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Memantina para la demencia

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Referencias

Referencias de los estudios incluidos en esta revisión

Ir a:

10116 (Lundbeck) {unpublished data only}

Completed memantine efficacy study. http://www.lundbecktrials.com/Completed.aspx?molecule=Memantine&indication=Moderate%20to%20severe%20alzheimer's%20disease&sponsor=lundbeck.

9202/Wilcock 2002 {published and unpublished data}

Orgogozo J, Forette F, Wilcock HG, Moebius HG, Stoeffler A. Memantine in vascular dementia.. Journal of the Neurological Sciences. Papers from the 2nd Congress on Vascular Dementia, Salzburg, Austria, 24‐27 January 2002.. 2002; Vol. 203‐204:318.
Stoeffler A, Wirth Y, Moebius HJ. Positive effects of one‐year treatment with memantine in vascular dementia.. Positive effects of one‐year treatment with memantine in vascular dementia.. 2005.
Wilcock G. Cognitive improvement by memantine in a placebo‐controlled trial in mild to moderate vascular dementia (The MMM 500 trial). 6th Internationa Stockholm/Sprinfield symposium on advances in Alzheimer Therapy. April 5‐8, 2000. Stockholm. 2000.
Wilcock G. Efficacy of memantine has been verified by two double‐blind studies [Wirkssamkeit von Memantine durch zwei Doppelblindstudien belegt]. Neurologie und Rehabilitation 2000;6(4):226‐7.
Wilcock G, Möbius HJ, Stöffler A on behalf of the MM 500 group. A double‐blind, placebo‐controlled multicentre study of memantine in mild to moderate vascular dementia. International Clinical Psychopharmacology 2002;17:297‐305.
Wilcock G, Stöffler A, Sahin K, Möbius HJ. Neuroradiological findings and the magnitude of cognitive benefit by memantine treatment. A subgroup analysis of two placebo controlled clinical trials. Proceedings of the 13th European College of Neuropsychopharmacology. 2000a; Vol. 10, issue suppl 3:S360.

9403/Winblad 1999 {published data only}

Doody R, Wirth Y, Schmitt F, Mobius H J. Specific functional effects of memantine treatment in patients with moderate to severe Alzheimer's disease.. Dementia and geriatric cognitive disorders 2004;18(2):227‐32.
Doody R, Wirth Y, Schmitt F, Moebius HJ. Functional benefits of memantine treatment for patients with moderate to severe Alzheimer's disease. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Winblad B, Poritis N. Memantine in severe dementia: results of the 9M‐BEST study (Benefit and efficacy in severly demented patients during treatment with memantine). International Journal of Geriatric Psychiatry 1999;14:135‐146.
Winblad B, Poritis N, Möbius HJ. Clinical improvement in a placebo‐controlled trial with memantine in care‐dependent patients with severe dementia (M‐BEST). In: Iqbal K, Swaab DF, Wisniewski HM editor(s). Alzheimer's disease and related disorders etiology, pathogenesis and therapeutics. Chichester, New York, Weinheim, Brisbane, Singapore, Toronto: John Wiley and Sons, 1999:633‐640.

9408/Orgogozo 2002 {published data only}

Orgogozo JM, Forette F. Efficacy of memantine in mild to moderate vascular dementia (The MMM300 Trial). 6th International Stockholm/ Springfield Symposium on Advances in Alzheimer Therapy; 2000 April 5‐8, Stockholm. 2000.
Orgogozo JM, Rigaud AS, Stöffler A, Möbius HJ, Forettte F. Efficacy and safety of memantine in patients with mild to moderate vascular dementia. A randomised, placebo‐controlled trial (MMM300 Trial Group). Stroke 2002;33:1834‐1839.

9605/Reisberg 2003 {published data only}

Doody R, Wirth Y, Schmitt F, Mobius H J. Specific functional effects of memantine treatment in patients with moderate to severe Alzheimer's disease. Dementia and geriatric cognitive disorders 2004;18(2):227‐32.
Doody R, Wirth Y, Schmitt F, Moebius HJ. Functional benefits of memantine treatment for patients with moderate to severe Alzheimer's disease.. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Feldman H, Schmitt FA, Doraiswamy PM, Graham SM, Bell JM. Memantine and Individual Activities of Daily Living in Moderate to Severe Alzheimer's Disease.. In: 57th Annual Meeting of the American Academy of Neurology, Miami Beach, April 2005. 2005.
Feldman H, Schmitt FA, PFeiffer E, Graham SM, Bell JM. Memantine and individual activities of daily living in moderate to severe Alzheimer's disease.. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Ferris S. Clinical trial of memantine in severe Alzheimer disease: rationale and design. Proceedings of the 9th Congress of the International Psychogeriatric Association, Aug 15‐20 1999, Vancouver. 1999.
Gauthier S, Wirth Y, Mobius HJ. Effects of memantine on behavioural symptoms in alzheimer's disease patients: an analysis of the neuropsychiatric inventory (npi) data of two randomised, controlled studies.. International Journal of Geriatric Psychiatry 2005;20(5):459‐64.
Gauthier S, Wirth Y, Moebius HJ. Positive behavioural effects of memantine treatment in patients with Alzheimer's disease. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005 2005. Positive behavioural effects of memantine treatment in patients with Alzheimer's disease. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Moebius HJ, Wirth Y, Gauthier S. Memantine: Behavioral Benefits for Moderate to Severe Alzheimer's Patients.. 57th Annual Meeting of the American Academy of Neurology, Miami Beach, April 2005. 2005:P02.095.
Reisberg B, Doody R, Stöffler A, Schimitt F, Ferris S, Möbius HJ for the Memantine Study group. Memantine in Moderate to Severe Alzheimer´s Disease. The New England Journal of Medicine 2003;348:1333‐1341.
Reisberg B, Ferris S. Experimental therapeutic shows promise for people with moderately severe to severe Alzheimer's disease. World Alzheimer Congress 2000. 2000.
Reisberg B, Ferris S, Sahin K, Windscheif U, Möbius HJ. Results of a placebo‐controlled 6 month trial with memantine in moderate to severe Alzheimer's disease. Journal of the European College of Neuropsychopharmacology 2000;10(suppl 3):S363‐4.
Reisberg B, Möbius HJ, Stöffler A, Schmitt F, Doody R, Ferris S. Long treatment with the NMDA antagonist memantine results of a 24 week open label extension study in moderately severe to severe Alzheimer's disease. The 8th Conference on Alzheimer's disease and related disorders, July 20‐25, 2002, Stockholm, Sweden. 2002.
Reisberg B, Stöffler A, Ferris SH, Schmitt F, Doody RS. A placebo controlled study of memantine in advanced Alzheimer's disease. Proceedings of the 15th Annual Meeting of the American Psychiatric Association; 2001 May 5‐10, New Orleans. 2001.
Reisberg B, Windscheif U, Ferris SH, Hingorani VN, Stöffler A, Möbius HJ. Memantine in moderately severe to severe Alzheimer's disease: Results of a placebo‐controlled 6 month trial. Conference proceedings Worl Alzheimer Congress; 9‐13 July, 2000. Washington. 2000.
Reisberg B, Windscheif U, Ferris SH, Stöffler A, Möbius HJ and the Memantine Study Group. Treatment of advanced Alzheimer's disease with memantine, an NMDA antagonist: results of a 6 month multicenter randomized controlled trial. Proceedings of the 39th Annual Meeting of the American College of Neuropsychopharmacology; Dec 10‐14, 2000. San Juan, Puerto Rico. 2000.
Wimo A, Winblad B, Stoeffler A, Wirth Y, Moebius HJ. Effect of long term treatment with memantine, an NMDA antagonist, on costs associated with advanced Alzheimer's disease: results of a 28‐week randomized double‐blind, placebo‐controlled study. Proceedings of the 8th International Conference on Alzheimer's Disease and Related Disorders; 2002 July 20‐25, Stockholm, Sweden. 2002:Abstract No 167.
Wimo A, Winblad B, Stoeffler A, Wirth Y, Moebius HJ. Resource utilisation and cost analysis of memantine in patients with moderate to severe Alzheimer's disease. PharmacoEconomics 2003;21(5):327‐40.

99679(Lundbeck) {unpublished data only}

Anon. Forest press release ‐ 7 Jan 03. http://ir.frx.com/phoenix.zhtml?c=83198&p=irol‐newsArticle&ID=482107&highlight=.
Bakchine S, Pascual‐Gangnant L, Loft H. Results of a randomised, placebo‐controlled 6‐month study of memantine in the treatment of mild to moderate Alzheimer's disease in Europe.. Conference proceeding. 2005.
Doody RS, Tariot PN, Pfeiffer E, Olin JT, Graham SM, & Bell JM. Meta‐analysis of six month memantine clinical trials. Conference Proceeding: New Clinical Drug Evaluation Unit 45 Annual Meeting. Boca Raton, Florida, June 6‐9 2005. 2005.

Ditzler 1991 {published data only}

Ditzler K. Efficacy and tolerability of memantine in patients with dementia syndrome. Arzneimittelforschung 1991;41(8):773‐80.

Gortelmeyer 1992 {published data only}

Gortelmeyer R, Erbler H. Memantine in the treatment of mild to moderate dementia syndrome. A double‐blind placebo‐controlled study. Arzneimittelforschung 1992;42(7):904‐913.

MD‐01 {unpublished data only}

FDA. Peripheral and Central Nervous System Drugs Advisory Committee September 24, 2003. Presentation by Forest, Slide 28.. http://www.fda.gov/ohrms/dockets/ac/03/slides/3979S1_01_F‐Forest‐Backup.ppt.
Forest Laboratories I. A randomized, double‐blind, placebo‐controlled evaluation of the safety and efficacy of memantine in patients with moderate to severe dementia of the Alzheimer's type. http://www.forestclinicaltrials.com/CTR/CTRController/CTRCompletedListStudies2005.
Peterson L. American Neurological Association. November 2003.. http://www.trends‐in‐medicine.com/Nov2003/AmNeuro113p.pdf.

MD‐02/Tariot 2004 {published data only}

Cummings JL, Schneider E, Peskind E, Tariot P, Graham SM, Bell JM. Effect of memantine on behavioral outcomes in Alzheimer's disease. In: IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Feldman H, Schmitt FA, Doraiswamy PM, Graham SM, Bell JM. Memantine and Individual Activities of Daily Living in Moderate to Severe Alzheimer's Disease. In: 57th Annual Meeting of the American Academy of Neurology, Miami Beach, April 2005. 2005.
Feldman H, Schmitt FA, PFeiffer E, Graham SM, Bell JM. Memantine and individual activities of daily living in moderate to severe Alzheimer's disease. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Finucane Thomas E. Memantine for Patients With Alzheimer Disease. JAMA: Journal of the American Medical Association 2004;291(14):1695.
Forest Laboratories I. A randomized, double‐blind, placebo‐controlled evaluation of the safety and efficacy of memantine in patients with moderate to severe dementia of the Alzheimer's type.. http://www.forestclinicaltrials.com/CTR/CTRController/CTRCompletedListStudies 2005..
Gauthier S, Wirth Y, Mobius HJ. Effects of memantine on behavioural symptoms in alzheimer's disease patients: an analysis of the neuropsychiatric inventory (npi) data of two randomised, controlled studies. International Journal of Geriatric Psychiatry 2005;20(5):459‐64.
Tariot P, Farlow M, Grossberg T, Graham S, McDonald S, Gergel I For the memantine study group. Memantine treatment in patients with moderate to severe Alzheimer Disease already receiving donopezil. A randomized controlled trial. JAMA 2004;291:317‐324.
Tariot PN. Memantine for Patients With Alzheimer Disease: Reply to Funicane. JAMA: Journal of the American Medical Association 2004;291(14):1695.

MD‐10/Peskind 2004 {published and unpublished data}

Bakchine S, Pascual‐Gangnant L, Loft H. Results of a randomised, placebo‐controlled 6‐month study of memantine in the treatment of mild to moderate Alzheimer's disease in Europe. Results of a randomised, placebo‐controlled 6‐month study of memantine in the treatment of mild to moderate Alzheimer's disease in Europe. 2005.
Cummings JL, Schneider E, Peskind E, Tariot P, Graham SM, Bell JM. Effect of memantine on behavioral outcomes in Alzheimer's disease. In: IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Peskind ER, Potkin SG, Pomara N, McDonald S, Xie Y, Gergel I. Memantine monotherapy is effective and safe for the treatment of mild to moderate Alzheimer's disease: A randomized controlled trial. American Association for Geriatric Psychiatry 17th Annual Meeting, Baltimore MD, February 21‐24. 2004.
Peskind ER, Potkin SG, Pomara N, Ott BR, McDonal S, Gergel I. Memantine monotherapy is effective and safe for the treatment of mild to moderate Alzheimer's disease: A randomized controlled trial. CINP Cogress, Paris. June 2‐24. 2004.
Pomara N, Ott B, Peskind E, Resnick EM. Efficacy of memantine for cognition in mild to moderate Alzheimer's disease.. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.
Potkin SG, Peskind ER, Pomara N, McDonald S, Xie Y, Gergel I. Memantine monotherapy is effective and safe for the treatment of mild to moderate Alzheimer's disease: Arandomized controlled trial. 56th Annual meeting of the American Academy of Neurology,San Francisco CA, April 24‐may 1. 2004.

MD‐12 {unpublished data only}

Doody RS, Tariot PN, Pfeiffer E, Olin JT, Graham SM, & Bell JM. Meta‐analysis of six month memantine clinical trials. New Clinical Drug Evaluation Unit 45 Annual Meeting. Boca Raton, Florida, June 6‐9 2005 .. 2005.

MRZ‐9104 {unpublished data only}

Anon. NDA Safety review ‐ August 2003. http://www.fda.gov/ohrms/dockets/ac/03/briefing/3979B1_04_FDA‐Safety%20Review.pdf.

MRZ‐9105 {unpublished data only}

Anon. NDA Safety review ‐ August 2003. http://www.fda.gov/ohrms/dockets/ac/03/briefing/3979B1_04_FDA‐Safety%20Review.pdf.

MRZ‐9206 {unpublished data only}

Anon. NDA Safety review ‐ August 2003. http://www.fda.gov/ohrms/dockets/ac/03/briefing/3979B1_04_FDA‐Safety%20Review.pdf.

Pantev 1993 {published data only}

Pantev M, Ritter R, Gortelmeyer R. Clinical and behavioural evaluation in long‐term care patients with mild to moderate dementia under memantine treatment. Zeitschrift fuer Gerontopsychologie und Psychiatrie 1993;6(2):103‐17.

Referencias de los estudios excluidos de esta revisión

Ir a:

Ambrozi 1988 {published data only}

Ambrozi L, Danielczyk W. Treatment of impaired cerebral function in psychogeriatric patients with memantine. Results of a Phase II double‐blind study. Pharmacopsychiatry 1988;21(3):144‐6.

Fleischhacker 1986 {published data only}

Fleischhacker WW, Buchgeher A, Schubert H. Memantine in the treatment of senile dementia of the Alzheimer type. Progress Neuro‐Psychopharmacology and Biological Psychiatry 1986;10:87‐93.

Gavrilova 1995 {published data only}

Gavrilova S, Selezneva N, Kolykhalov I, Mikhailova N, Kalyn Y, Roschina I. Glutaminergic approach to the treatment of Alzheimer type dementia. Xth World Cogress of Psychiatry. Vol 2; 1996 Aug 23‐28, Madrid. 1996.
Gavrilova S, Seleznyova N, Kolykhalov I, et al. [Heterogeneity of anti‐dementia drug response in Alzheimer type dementia]. Proceedings of the 8th European College of Neuropharmacology Congress (ECNP); 1995 Sep 30‐ 0ct 4, Venice. 1995.

Jones 2005 {published data only}

Jones R, Bayer A, Inglis F, Phul R. Once‐daily dosing of memantine found to be as safe and tolerable as twice‐daily dosing in a 12‐week, double‐blind study in moderate to severe Alzheimer's disease. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005 2005.

Riepe 2005 {published data only}

Riepe MW, Adler G, Ibach B, Weinkauf B, Tracik F. Adding Memantine to Therapy with Rivastigmine in Patients with Mild To Moderate Alzheimer's Disease: Results of a 12‐Week Pilot Study. 57th Annual Meeting of the American Academy of neurology, Miami Beach, April 2005. 2005, issue P06.081.

Scharre 2005 {published data only}

Scharre DW, Warner JL, Knick JA, Davis RA, Theado‐Miller N. Memantine in Frontotemporal Dementia. 57th Annual Meeting of the American Academy of Neurology, Miami Beach, April 2005. 2005, issue P02.078.

Referencias de los estudios en curso

Ir a:

95722/Ashford {published data only}

Ashford JW. The Effect of Memantine on Brain Structure and Chemistry in Alzheimer's Disease Patients: A Randomized, Placebo‐Controlled, 52‐Week Clinical Trial. Clinicaltrials.gov2005.

Bullock 2005 {published data only}

Bullock R. Making Evidence‐based Decisions Using Alzheimer Therapy (MEDUSA Therapy). ISRCTN Register //http://www.controlled‐trials.com/mrct2005.

CSP#546 {published data only}

Anon. CSP#546 ‐ A RANDOMIZED, MULTICENTER, DOUBLE‐BLIND, PLACEBO‐CONTROLLED TRIAL OF DL‐ALPHA‐TOCOPHEROL AND MEMANTINE FOR THE TREATMENT OF FUNCTIONAL DECLINE IN OUTPATIENTS WITH ALZHEIMER'S DISEASE ON DONEPEZIL. ClinicalTrials.gov2005.

MD‐22 {published data only (unpublished sought but not used)}

Forest Laboratories Inc. A randomised, double‐blind, placebo‐controlled evaluation of the effectiveness and safety of memantine in nursing home residents with moderate to severe Alzheimr's disease.. http://www.forestclinicaltrials.com2005.

MD‐23 {published data only (unpublished sought but not used)}

Forest Laboratories Inc. A randomised, double‐blind, placebo‐controlled evaluation of the effectiveness and safety of memantine in non‐institutionalised agitated patients with moderate to severe Alzheimr's disease. http://www.forestclinicaltrials.com2005.

MD‐51 {published data only}

Forest Laboratories Inc. An Open‐Label Evaluation of the Safety of Memantine in Patients with Moderate‐to‐Severe Dementia of the Alzheimer's Type. http://www.forestclinicaltrials.com2005.

MEM‐MD‐50 {published data only}

Forest Laboratories Inc. A Randomized, Double‐Blind, Placebo‐Controlled Evaluation of the Safety and Efficacy of Memantine in Patients with Moderate‐to‐Severe Dementia of the Alzheimer's Type.. http://www.forestclinicaltrials.com2005.

Reisberg 2005 {published data only}

Reisberg B. Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial. ClinicalTrials.gov2005.

SUN Y7017 {published data only (unpublished sought but not used)}

memantine versus placebo for severe to moderately severe AD. Ongoing study Starting date of trial not provided. Contact author for more information.

SUN Y7017m {published data only (unpublished sought but not used)}

memantine versus placebo for mild to moderate AD. Ongoing study Starting date of trial not provided. Contact author for more information.

Vasavan Nair 2004 {published data only}

Vasavan Nair NP. Memantine in moderate to advanced Alzheimer disease for patients with behavioural problems. http://www.douglasrecherche.qc.ca2004.

Alva 2005a

Alva G, Farlow MR, Lee G, Wirth Y, Graham S. Update of memantine safety in short‐and long‐term treatment of dementia. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.

Alva 2005b

Alva G, Farlow MR, Porsteinsson A, Graham SM, Schneider E, Jonas JM, Stöffler A. Update of Memantine Safety in Short‐ and Long‐Term Treatment of Dementia. 57th Annual Meeting of the American Academy of Neurology, Miami Beach, April 2005. 2005:P02.098.

Anonymous 2003

Anonymous. FDA approves memantine drug for treating AD. Am J Alzheimers Dis Other Demen 2003;18(6):329‐30.

Cacabelos 1999

Cacabelos R, Takeda M, Winblad B. The glutamatergic system and neurodegeneration in dementia: Preventive strategies in Alzheimer's disease. International Journal of Geriatric Psychiatry 1999;14:3‐47.

Chalmers 1983

Chalmers TC, Celano P, Sacks HS, Smith HJr. Bias in treatment assigment in controlled clinicals trials. New England Journal of Medicine 1983;309:1358‐61.

Cummings 1994

Cummings JL, Mega M, Gray K, Rosenberg‐Thompson S, Carusi DA, Gorrnbein J. The Neuropsychiatric inventory: comprehensive assessment of psychopathology in dementia. Neurology 1994;44:2308‐2314.

Dresser 2000

Dresser R. Weighing the benefits of new Alzheimer's treatments. Science 2000;289:869.

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American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 3th edition revised. Washington D.C.: American Psychiatric Association, 1987.

DSM IV

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th Edition. Washington D.C.: American Psychiatric Association, 1994.

EMEA 2004

European Medicines Agency. Ebixa. European Public Assessment Report. www.emea.eu.int/humandocs/Humans/EPAR/ebixa/ebixa.htm2004.

Emre 2001

Emre M, Qizilbash N. Experimental approaches and drug in development for the treatment of dementia. Expert Opinion on Investigational Drugs 2001;10(4):607‐17.

Folstein 1975

Folstein MF, Folstein SE, McHugh PR. Mini‐mental state: a practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatry Research 1975;12:189‐198.

Forest 2003

FDA approves Namenda(TM)(Memantine HCl) for the treatment of moderate to severe Alzheimer's disease. http://ir.frx.com/phoenix.zhtml?c=83198&p=irol‐newsArticle&ID=459801&highlight=..

Forest 2005a

Forest Labs, Inc, announces launch of clinical trial registry http://www.forestclinicaltrials.com. http://ir.frx.com/phoenix.zhtml?c=83198&p=irol‐newsArticle&ID=671761&highlight=..

Forest 2005b

Forest Laboratories announces FDA decision on supplemental new drug application for Namenda. http://www.frx.com/news/PressRelease.aspx?ID=734345.

Galasko 1997

Galasko D, Benett D, Sano M, Ernesto C, Thomas R, Grundman M, Ferris S. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's Disease Cooperative Study. Alzheimer's Disease and Associated Disorders 1997;11:S33‐S39.

Gottfries 1982

Gottfries CG, Brane G, Gullberg B, Steen G. A new rating scale for dementia syndromes.. Arch Gerontol Geriatr 1982;1:311‐330.

Guy 1976

Guy W. CGI: Clinical global impressions. In: Guy W editor(s). ECDEU Assessment Manual for Psychopharmacology. Rev. Rockville: National Institutes of Health, 1976:217‐20.

Honigfeld 1974

Honigfeld G, NOSIE 30. History and current status of its use in pharmaco‐psychiatric research. In: Pichot P editor(s). Modern Problems of Pharmacopsychiatry. Vol. 7 Psychological Measurements in Psychopharmacology, Germany: Karger, 1974:238.

Kalaria 1999

Kalaria RN, Ballard C. Overlap between pathology of Alzheimer disease and vascular dementia. Alzheimer Disease and Associated Disorders 1999;13(suppl 3):S115‐S123.

Kim 1993

Kim YS, Nibbelink DW, Overall JE. Factor structure and scoring of the SKT battery. Journal of Clinical Psychology 1993;49(1):61‐71.

Kornhuber 1997

Kornhuber J, Weller M. Psychotogenicity and N‐methyl‐D‐aspartate Receptor Antagonism: Implications for Neuroprotective Pharmacotherapy. Biological Psychiatry 1997;41:135‐44.

Lundbeck 2005

Ebixa extended approval for the treatment of moderate Alzheimer's disease. http://www.lunbeck.com/investor/releases/ReleaseDetails/Release_173_EN.asp.

McKhann 1984

McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS‐ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology 1994;34:939‐944.

Mulrow 1997

Mulrow CD, Oxman CD. Cochrane Collaboration Handbook (updated 9 December 1996). The Cochrane Library [database on disk and CDROM]. Oxford, UK: Update Software, 1997, issue 1.

Möbius 1999

Möbius HJ. Pharmacologic rationale for memantine in chronic cerebral hypoperfusion, especially vascular dementia. Alzheimer Disease and Associated Disorders 1999;13(suppl 3):S172‐S178.

NICE 2005

National Institute for Clinical Excellence. http://www.nice.org.uk/page.aspx?o=104058.

NICE 2006

National Institute for Clinical Excellence. National Institute for Clinical Excellence. http://www.nice.org.uk/page.aspx?o=104058..

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Parsons CG, Danysz W, Quack G. Memantine is a clinically well tolerated N‐methhyl‐D‐aspartate (NMDA) receptor antagonist‐ a review of preclinical data. Neuropharmacology 1999;38:735‐767.

Plosker 2005

Plosker GL, Lyseng Williamson KA. Memantine: a pharmacoeconomic review of its use in moderate‐to‐severe Alzheimer's disease. PharmacoEconomics 2005;23(2):193‐206.

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Post SG. Slowing the progression of Alzheimer disease: ethical issues. Alzheimer Disease and Associated Disorders 1997;11(suppl 5):S34‐9.

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Wimo A, Winblad B, Stoffler A, Wirth Y, Mobius HJ. Resource utilisation and cost analysis of memantine in patients with moderate to severe Alzheimer's disease. Pharmacoeconomics 2003;21(5):327‐40.

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Winblad B, Hefting N, Loft H. Memantine improves behavioural symptoms in patients with mild to severe Alzheimer's disease. IPA 12th International Congress, Stockholm, Sweden, 20‐24 September 2005. 2005.

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ir a:

10116 (Lundbeck)

Methods

Randomised
double‐blind
parallel‐group
placebo controlled

Participants

Interventions

Outcomes

'Efficacy, safety and tolerability'

Notes

Started in 2002
Further details not available
Lundbeck Trial Registry

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used
9202/Wilcock 2002

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 28 weeks

Participants

Country: UK
No of Centres: 57
Diagnosis: vascular dementia according to the NICDS‐AIREN criteria.
Inclusion: MMSE: 10‐22.
Exclusion: Secondary dementia, depressive pseudodementia, psychotic episodes, history of epilepsy or acute or poorly controlled illness. Other investigational drugs, psychotropic drugs, drugs with psychiatric side effects and oral anticoagulants were not allowed.
Total No: 579
Age (years+‐ SD): Memantine: 77,2+‐6,9; Placebo: 77,6+‐7.
Sex (female%): Memantine: 48%; Placebo: 49%

Interventions

Route: Oral
Treatment: Memantine: 20 mg /day
Control: Placebo

Outcomes

Primary end points: ADAS‐cog, CGI‐C
Secondary outcomes: NOSGER

Notes

ITT Population: 548 (95%).
PP Population: 368 (64%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
9403/Winblad 1999

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duaration: 12 weeks

Participants

Country: Latvia
No of centres: 7
Diagnosis: DSM‐III‐R for the diagnosis of dementia and used the Hachinski ischaemia score (HIS) modified by Rosen to separate subgroups with AD and VD.
Exclusion:
drugs affecting central nervous system, chronic or terminal diseases, progressive heart failure, severe renal impairment, impaired thyroid function, severe cardiac arrhythmia, unstable diabetes mellitus, chronic liver disease, low vitamin B12, abnormal blood chemistry, alcoholism, drug abuse, major depression, epilepsy, Parkinson's disease. Use of neuroleptics, tricyclic antidepressants, hypnotics, nootropics, drugs stimulating cerebral circulation, MAO inhibitors.
Total No: 166
Age: females: 73,9+‐5,6; males: 68,4+‐5,6
Sex (female %):
Memantine: 59,8%; placebo: 56%.

Interventions

Route: Oral
Treatment: memantine 10 mg/ day.
Treatment started at 5 mg/day and increased in one week to 10 mg/day
Control: Placebo: o.i.d.

Outcomes

Primary end points:
Clinical Global Impression of Change (CGI‐C).
Behavioural Rating Scale for Geriatric Patients (BGP).
‐ Secondary efficacy variables:
D‐scale
Adverse events describing spontaneous reports.

Notes

ITT Population: 166 (98%)
PP Population: 151 (90%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
9408/Orgogozo 2002

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 28 weeks

Participants

Country: France, Belgium and Switzerland
No of centres: 50
Diagnosis:
probable vascular dementia by NINDS‐AIREN and HIS >=5.
Inclusion: MMSE: 12‐20
Exclusion criteria: Alzheimer's disease and secondary types of dementia. History of seizures, alcoholism, drug abuse, chronic users of medications with the potential to interfere with the outcomes, psychotic episodes. Concomitant use of anticonvulsants, anti‐Parkinson medications, hypnotics, anxiolytics, antipsychotics, centrally‐ acting antihypertensives and cognition enhancers.
Total No of patients: 321
Age: Placebo: 76,1+‐8,68; Memantine: 76,6+‐6,6
Sex (%females): Memantine: 52,5%; Placebo: 43%.

Interventions

Route: Oral
Treatment: memantine 20 mg/day
Treatment started at 5 mg/day and increased in three weeks to 20 mg/day
Control: Placebo o.i.d.

Outcomes

‐ Primary endpoints:
ADAS‐Cog (Alzheimer's Disease Assessment Scale, cognitive subscale/11 items)
CIBIC‐PLUS (Clinician's Interview Based Impression of Change)
‐ Secondary efficacy variables:
MMSE (Mini Mental State Examination)
Gottsfries‐Brane‐Steen (GBS) scale.
Clinical Global Impression of Change.
Nurse's Observational Scale for Geriatric Patients (NOSGER)
Safe and tolerability

Notes

ITT population: 288 (90%)
PP Population: 188 (59%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
9605/Reisberg 2003

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 28 weeks

Participants

Country: USA
No of centres: 32
Diagnosis: Alzheimer's disease by DSM‐IV and NINCDS‐ADRDA
Inclusion: MMSE:3‐14; GDS:6; FAST: 6
Exclusion: vascular dementia, or other clinically significant neurological disease, major depressive disorder, or a score greater than 4 on the Modified Hachinski Ischaemia Rating Scale.
Total No of patients: 252
Age: 76,1+‐8,07.
Sex (females%): Memantine: 72,2; Placebo: 65,5.
Baseline SIB˜67

Interventions

Route: oral
Treatment: memantine 20 mg /day
Control:
Placebo

Outcomes

Primary end points: NYU CIBIC‐plus; Modified; Modified ADCS‐ADL Inventory
Secondary outcomes: Severe Impairment Battery (SIB); FAST, NPI

Notes

ITT Population: 236 (94%).
PP Population: 181 (72%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
99679(Lundbeck)

Methods

Randomized, double‐blind, parallel‐group, placebo‐controlled
Duration: 26 weeks

Participants

Mild to moderate AD 65 European sites

Interventions

20 mg monotherapy

Outcomes

Primary end points: CIBIC+, ADAS‐Cog; Secondary: ADCS‐ADL23, NPI

Notes

ITT population: 461/470
2:1 memantine to placebo allocation

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Ditzler 1991

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 6 weeks

Participants

Country: Germany
No. of centres: not stated
Diagnosis: dementia syndrome. No stated criteria.
Inclusion: Mild to moderate dementia according to the Lausanne scale and SCAG score of 50 or more.
Exclusion: kidney function disturbances, cholestasis, uncompensated congestive heart failure, stroke or head trauma 6 months before the study, brain tumours, endogenous psychoses, drugs or alcohol abuse, Parkinson's disease, intolerance to the test product. Not permitted: nootropics, neuroleptics, drugs for promoting cerebral blood flow, antidepressants, sleeping agents (except chloral hydrate or in exceptional cases a short‐acting benzodiazepine), antiparkinsonians, myotonolytics, reserpine, ergot alkaloids or their derivatives.
Total No. of patients: 66
Age: 72,2 (60‐84)
Sex (%females): 65%

Interventions

Route: Oral
Treatment: memantine: 30 mg. Treatment commenced at 10 mg/day and in 2 weeks increased to 30 mg/day

Outcomes

Physician's global impression,, SCAG, The Syndrom‐ Kurtztest, ADL test.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
Gortelmeyer 1992

Methods

Randomized
double‐blind
parallel‐group
placebo‐Controlled
Duration: 6 weeks

Participants

Country: Germany
No. of centres: 2
Diagnosis: dementia defined by DSM‐III.
Inclusion: SCAG score > 50. Exclusion: participation in a study the last 4 weeks, impaired renal function, cholestasis, decompensated heart failure, stroke or cerebral trauma in the last 6 months, brain tumour, endogenous psychoses, drug and alcohol abuse, Parkinson's disease, intolerance to the test product. Not permitted: nootropics, antidepressants, neuroleptics, hypnotics (except chloral hydrate and in exceptional cases benzodiazepine with a short half‐life), antiparkinsonian drugs, myotonolytics, reserpine containing drugs, ergot alkaloids and their derivatives.
Total No: 88
Age: 71,52 (59‐96).
Sex (%female): 75%

Interventions

Route: Oral
Treatment: memantine 20 mg/ day. Treatment commenced at 10 mg/day and after 3 days was increased to 20 mg/day.
Control: Placebo 1 tablet the first 3 days and after 2 tablets/day

Outcomes

SCAG, CGI, GBS, ADL behaviour investigation, Tapping test, trace test.

Notes

No. not included in the analysis: 83

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
MD‐01

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 24 weeks

Participants

Country: US
350 patients
moderate to severe AD.
Diagnosis: Alzheimer´s disease by NlNCDS‐ADRDA;
Inclusion: MMSE: 5‐14. Age at least 50.
Age: placebo: 78 +‐7.6, memantine:78 +‐8.2
Sex (%females): placebo: 70.3%, memantine: 72.5%. Baseline SIB: ˜76

Interventions

Route: oral
Treatment: 20 mg memantine daily
Control: placebo

Outcomes

Primary end points: SIB, ADCS‐ADL19.
Secondary outcomes: CIBIC‐Plus, NPI, BGP, FAST

Notes

ITT Population: 336 (96%)
PP Population: 260 (74%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
MD‐02/Tariot 2004

Methods

Randomized
double‐blind
parallel‐group placebo‐controlled.
Duration: 24 weeks

Participants

Country: USA
No of centers: 37
Diagnosis: Alzheimer´s disease by NlNCDS‐ADRDA;
Inclusion: MMSE: 5‐14; older than 50 years; ongoing donepezil therapy for more than 6 months before entrance into the trial and at a stable dose for at least 3 months, a knowledgeable and reliable caregiver, ambulatory ability and stable medical condition and medications.
Excluded:
Clinically significant B12 or folate defeciency; active pulmonary, gastrointestina, renal, hepatic, endocrine, or cardiovascular disease; other psychiatric or central nervous system disorders other than AD, HIS more than 4.
Baseline SIB ˜79

Interventions

Route: oral
Treatment: Memantine 20 mg/day and donepezil 5 or 10 mg/day.
Control: Placebo and donepezil 5‐10 mg/day.

Outcomes

Primary end points: SIB, ADCS‐ADL19.
Secondary outcomes: CIBIC‐Plus, NPI, BGP.

Notes

‐ ITT Population: 395 (98%)
‐ PP Population: 322 (80%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate
MD‐10/Peskind 2004

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Durantion: 24 weeks

Participants

Country: USA
No. of Centres: not stated
Diagnosis: Alzheimer's disease by NINCDS‐ADRDA
Inclusion: MMSE: 10‐22
Exclusion: not stated
Total No of patients: 403
Age: placebo: 77 +‐8,2, mamantine:78 +‐7,3
Sex (%females): placebo: 57,4%, memantine: 60,2%

Interventions

Route: oral
Treatment: memantine 20 mg/day (10 mg b.i.d. titrated over a 4‐week period) Control: placebo

Outcomes

Primary end points: ADAS‐Cog, CIBIC‐plus
Secondary outcomes: ADCS‐ADL, NPI, Safety

Notes

‐ ITT Population: 394 (98%)
‐ PP Population: 332 (82%)

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
MD‐12

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 24 weeks

Participants

Country: US
432 participants
mild to moderate AD on ChEI

Interventions

Route: oral
Treatment: memantine 20 mg/day (10 mg b.i.d. titrated over a 4‐week period). On stable dose of ChEI. Control: placebo plus continued ChEI

Outcomes

ADAS‐Cog; Secondary: ADCS‐ADL23, NPI

Notes

ITT population: 427/433

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear
MRZ‐9104

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled

Participants

Country: France
56 participants
AD of unknown severity

Interventions

13 weeks 20 mg memantine monotherapy

Outcomes

Notes

No results available

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used
MRZ‐9105

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled

Participants

Country: Portugal
27 participants
Mild to moderate severe stages of primary dementia

Interventions

12 weeks monotherapy 20 mg memantine

Outcomes

Notes

No results available

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used
MRZ‐9206

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled

Participants

56 participants
Moderately severe VD

Interventions

Monotherapy 20 mg memantine 14 weeks

Outcomes

Notes

No results available

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

D ‐ Not used
Pantev 1993

Methods

Randomized
double‐blind
parallel‐group
placebo‐controlled
Duration: 6 weeks

Participants

Country: Germany
No. of Centres: not stated.
Diagnosis: DSM III‐R.
Inclusion: Lausanne scale and SCAG >=80.
Exclusion: participation in a study within the preceding 4 weeks, drug and alcohol abuse, known intolerance, severe chronic or terminal disease, decompensated hypertension, relevant heart disease, stroke in the last 3 months, impairment of liver or kidney function, secondary dementia, Parkinson's disease, seizures.
No. of participants: 60
Age: 72,4
Sex (%female): 75%

Interventions

Route: Oral
Treatment: memantine 30 mg/day.
Treatment commenced at 10 mg/day, increased by 10 mg/day at 2 and 7 days.
Control: Placebo (the same regime)

Outcomes

Global assessment of clinical efficacy, SCAG, BGP, NOSIE‐Index, Physician's global rating of tolerability

Notes

No. not included in the analysis: 59?

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

Ambrozi 1988

Included patients suffering from any severe chronic disease of the Central Nervous System.

Fleischhacker 1986

Single‐blind trial

Gavrilova 1995

Open clinical trial

Jones 2005

Not placebo controlled

Riepe 2005

Open label study

Scharre 2005

Not AD but frontotemporal dementia

Characteristics of ongoing studies [ordered by study ID]

Ir a:

95722/Ashford

Trial name or title

A Randomized, Placebo‐Controlled, 52‐Week Clinical Trial in patients with AD

Methods

Participants

‐N=20
‐country: USA

Interventions

memantine versus placebos

Outcomes

‐MRS measures of brain
‐NAA and MRI measures of hippocampal volume
‐ADAS‐Cog and caregiver and clinician ratings

Starting date

‐recruiting at 110106
‐Study start:May 2005; Expected completion:June 2007

Contact information

‐[email protected]
‐ClinicalTrials.gov Identifier: NCT00255086

Notes

blinding unclear
Bullock 2005

Trial name or title

MEDUSA: randomized controlled trial in patients with AD

Methods

Participants

‐N=75 (15 in each arm of the trial)
‐Country: UK

Interventions

1.ChEi as usual
2. increased dose of ChEi
3. rivastigmine
4. memantine
5. ChEi as usual, plus memantine

Outcomes

what evidence is there that altering therapy, after initial treatment starts to fail, will benefit the patient?

Starting date

unknown

Contact information

ISRCTN55568578

Notes
CSP#546

Trial name or title

randomised placebo controlled double‐blind trial in patients with mild to moderate AD taking donopezil

Methods

Participants

‐N=840
‐

Interventions

1. alpha‐tocopherol plus memantine placebo
2. memantine (Namenda) plus alpha‐tocopherol placebo
3.alpha‐tocopherol plus memantine
4.alpha‐tocopherol placebo plus memantine placebo

Outcomes

‐ADCS
‐ADL
‐ADAS‐cog
‐MMSE//NPI

Starting date

Jan 2006: not yet open for recruitment

Contact information

ClinicalTrials.gov Identifier: NCT00235716

Notes
MD‐22

Trial name or title

A randomised, double‐blind, placebo‐controlled evaluation of the effectiveness and safety of memantine in nursing home residents with moderate to severe AD

Methods

Participants

‐three months trial ‐USA

Interventions

memantine versus placebo

Outcomes

Starting date

5 October 2004

Contact information

www.forestclinicaltrials.com

Notes

recruitment finished in March 2005
MD‐23

Trial name or title

A randomised, double‐blind, placebo‐controlled evaluation of the effectiveness and safety of memantine in non‐institutionalised agitated patients with moderate to severe AD

Methods

Participants

USA

Interventions

Outcomes

Starting date

27 October 2004

Contact information

www.forestclinicaltrials.com

Notes
MD‐51

Trial name or title

Open‐Label Evaluation of the Safety of Memantine in Patients with Moderate‐to‐Severe Dementia of the Alzheimer's Type

Methods

Participants

Interventions

Outcomes

safety and tolerability of memantine in outpatients

Starting date

Recruitment: Open (at August 2005)

Contact information

http://www.forestclinicaltrials.com/CTR/CTRController/CTROngoingListStudies

Notes
MEM‐MD‐50

Trial name or title

A Randomized, Double‐Blind, Placebo‐Controlled Evaluation of the Safety and Efficacy of Memantine in Patients with Moderate‐to‐Severe Dementia of the Alzheimer's Type

Methods

Participants

Interventions

Outcomes

safety

Starting date

Start Date: 19‐MAY‐2005 //recruiting.

Contact information

http://www.forestclinicaltrials.com/CTR/CTRController/CTROngoingListStudies

Notes
Reisberg 2005

Trial name or title

randomized, controlled, single blind trial

Methods

Participants

‐N=20
‐Moderate to severe AD
‐USA

Interventions

comprehensive individualized management approach and memantine versus ???

Outcomes

Clinician Interview‐Based Assessment of Change Plus Caregiver Input (CIBIC‐Plus)//Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory modified for severe dementia (ADCS‐ADLsev)//Severe Impairment Battery//Mini‐Mental State Examination (MMSE)//Functional Assessment Staging//Global Deterioration Scale//Behavioral Pathology in Alzheimer's Disease‐Frequency Weighted//Memory and Behavior Problems Checklist

Starting date

‐Begin date: August 2005
‐Enddate: April 2006

Contact information

ClinicalTrials.gov Identifier: NCT00120874

Notes

DH: Difficult to make out from info available if it is memantine which is on trial or the management approach. On balance it is probably the latter and if so this trial does NOT belong here.

SUN Y7017

Trial name or title

memantine versus placebo for severe to moderately severe AD

Methods

Participants

Japan

Interventions

Outcomes

Starting date

Contact information

http://www.dsup.co.jp/eg/research/index.html

Notes

Daiichi Suntori Pharma
SUN Y7017m

Trial name or title

memantine versus placebo for mild to moderate AD

Methods

Participants

Japan

Interventions

Outcomes

Starting date

Contact information

http://www.dsup.co.jp/eg/research/index.html

Notes

Daiichi Suntori Pharma
Vasavan Nair 2004

Trial name or title

randomized controlled trial of memantine versus placebo for moderate to severe AD

Methods

Participants

‐N= ?
‐Country: Canada
‐CHIs allowed

Interventions

memantine versus placebo

Outcomes

behavioural aspects of moderate to advanced Alzheimer Disease, such as moodiness, irritability, indifference or apathy, pacing or wandering, changing eating habits or types of food preferred

Starting date

‐duration 6 months

Contact information

[email protected]

Notes

Is Gauthier involved in this trial?

Data and analyses

Open in table viewer
Comparison 1. Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data.

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: CIBIC+ (24‐28 weeks) Show forest plot

3

964

Mean Difference (IV, Fixed, 95% CI)

0.28 [0.15, 0.41]
Analysis 1.1
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 1 Clinical Global: CIBIC+ (24‐28 weeks).

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 1 Clinical Global: CIBIC+ (24‐28 weeks).

2 Cognitive function: SIB (change from baseline at 24‐28 weeks) Show forest plot

3

976

Mean Difference (IV, Fixed, 95% CI)

2.97 [1.68, 4.26]
Analysis 1.2
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 2 Cognitive function: SIB (change from baseline at 24‐28 weeks).

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 2 Cognitive function: SIB (change from baseline at 24‐28 weeks).

3 Activities of daily living: ADCS‐ADLsev19 (change from baseline at 24‐28 weeks) Show forest plot

3

978

Mean Difference (IV, Fixed, 95% CI)

1.27 [0.44, 2.09]
Analysis 1.3
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 3 Activities of daily living: ADCS‐ADLsev19 (change from baseline at 24‐28 weeks).

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 3 Activities of daily living: ADCS‐ADLsev19 (change from baseline at 24‐28 weeks).

4 Behaviour and mood: NPI total (change from baseline at 24‐28 weeks) Show forest plot

3

936

Mean Difference (IV, Fixed, 95% CI)

2.76 [0.88, 4.63]
Analysis 1.4
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 4 Behaviour and mood: NPI total (change from baseline at 24‐28 weeks).

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 4 Behaviour and mood: NPI total (change from baseline at 24‐28 weeks).

5 Number of dropouts Show forest plot

3

1006

Odds Ratio (M‐H, Fixed, 95% CI)

0.66 [0.49, 0.88]
Analysis 1.5
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 5 Number of dropouts.

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 5 Number of dropouts.

6 Number suffering at least one adverse event Show forest plot

3

1005

Odds Ratio (M‐H, Fixed, 95% CI)

1.13 [0.84, 1.52]
Analysis 1.6
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 6 Number suffering at least one adverse event.

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 6 Number suffering at least one adverse event.

7 Number suffering agitation as an adverse event Show forest plot

3

1005

Odds Ratio (M‐H, Fixed, 95% CI)

0.60 [0.42, 0.86]
Analysis 1.7
Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 7 Number suffering agitation as an adverse event.

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 7 Number suffering agitation as an adverse event.

Open in table viewer
Comparison 2. Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical global: CIBIC+ (at 24 weeks) Show forest plot

3

1281

Mean Difference (IV, Fixed, 95% CI)

0.13 [0.01, 0.25]
Analysis 2.1
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 1 Clinical global: CIBIC+ (at 24 weeks).

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 1 Clinical global: CIBIC+ (at 24 weeks).

2 Cognitive function: ADAS‐Cog (change from baseline at 24 weeks) Show forest plot

3

1279

Mean Difference (IV, Fixed, 95% CI)

0.99 [0.21, 1.78]
Analysis 2.2
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 2 Cognitive function: ADAS‐Cog (change from baseline at 24 weeks).

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 2 Cognitive function: ADAS‐Cog (change from baseline at 24 weeks).

3 Activities of daily living: ADCS‐ADL23 (change from baseline at 24 weeks) Show forest plot

3

1271

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.87, 1.27]
Analysis 2.3
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 3 Activities of daily living: ADCS‐ADL23 (change from baseline at 24 weeks).

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 3 Activities of daily living: ADCS‐ADL23 (change from baseline at 24 weeks).

4 Mood and behaviour: NPI total (change from baseline at 24 weeks) Show forest plot

3

1252

Mean Difference (IV, Fixed, 95% CI)

‐0.25 [‐1.48, 0.98]
Analysis 2.4
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 4 Mood and behaviour: NPI total (change from baseline at 24 weeks).

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 4 Mood and behaviour: NPI total (change from baseline at 24 weeks).

5 Number of dropouts Show forest plot

3

1306

Odds Ratio (M‐H, Fixed, 95% CI)

1.16 [0.83, 1.60]
Analysis 2.5
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 5 Number of dropouts.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 5 Number of dropouts.

6 Number suffering agitation as an adverse event Show forest plot

3

1306

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.57, 1.46]
Analysis 2.6
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 6 Number suffering agitation as an adverse event.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 6 Number suffering agitation as an adverse event.

7 Number suffering fall as an adverse event Show forest plot

2

836

Odds Ratio (M‐H, Fixed, 95% CI)

0.83 [0.41, 1.67]
Analysis 2.7
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 7 Number suffering fall as an adverse event.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 7 Number suffering fall as an adverse event.

8 Number suffering somnolence as an adverse event Show forest plot

1

403

Odds Ratio (M‐H, Fixed, 95% CI)

7.49 [1.68, 33.38]
Analysis 2.8
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 8 Number suffering somnolence as an adverse event.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 8 Number suffering somnolence as an adverse event.

9 Number suffering confusion as an adverse event Show forest plot

2

836

Odds Ratio (M‐H, Fixed, 95% CI)

1.40 [0.72, 2.70]
Analysis 2.9
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 9 Number suffering confusion as an adverse event.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 9 Number suffering confusion as an adverse event.

10 Number suffering at least one adverse event Show forest plot

3

1306

Odds Ratio (M‐H, Fixed, 95% CI)

1.04 [0.81, 1.33]
Analysis 2.10
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 10 Number suffering at least one adverse event.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 10 Number suffering at least one adverse event.

11 Number suffering depression as an adverse event Show forest plot

2

836

Odds Ratio (M‐H, Fixed, 95% CI)

0.71 [0.38, 1.32]
Analysis 2.11
Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 11 Number suffering depression as an adverse event.

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 11 Number suffering depression as an adverse event.

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Comparison 3. Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: CGI (at 28 weeks) ITT‐LOCF or OC Show forest plot

2

775

Mean Difference (IV, Fixed, 95% CI)

0.03 [‐0.13, 0.19]
Analysis 3.1
Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 1 Clinical Global: CGI (at 28 weeks) ITT‐LOCF or OC.

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 1 Clinical Global: CGI (at 28 weeks) ITT‐LOCF or OC.

2 Cognitive function ADAS‐Cog (change from baseline at 28 weeks) ITT‐LOCF Show forest plot

2

815

Mean Difference (IV, Fixed, 95% CI)

1.85 [0.88, 2.83]
Analysis 3.2
Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 2 Cognitive function ADAS‐Cog (change from baseline at 28 weeks) ITT‐LOCF.

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 2 Cognitive function ADAS‐Cog (change from baseline at 28 weeks) ITT‐LOCF.

3 Activities of daily living : NOSGER self care subscale (change from baseline at 28 weeks) OC Show forest plot

2

542

Mean Difference (IV, Fixed, 95% CI)

0.12 [‐0.43, 0.67]
Analysis 3.3
Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 3 Activities of daily living : NOSGER self care subscale (change from baseline at 28 weeks) OC.

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 3 Activities of daily living : NOSGER self care subscale (change from baseline at 28 weeks) OC.

4 Behaviour: NOSGER disturbing behaviour subscale (change from baseline at 28 weeks) OC Show forest plot

2

541

Mean Difference (IV, Fixed, 95% CI)

0.48 [0.06, 0.91]
Analysis 3.4
Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 4 Behaviour: NOSGER disturbing behaviour subscale (change from baseline at 28 weeks) OC.

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 4 Behaviour: NOSGER disturbing behaviour subscale (change from baseline at 28 weeks) OC.

Open in table viewer
Comparison 4. Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Activities of daily living (change from baseline at 12 weeks) Show forest plot

1

166

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐5.65, 1.65]
Analysis 4.1
Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 1 Activities of daily living (change from baseline at 12 weeks).

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 1 Activities of daily living (change from baseline at 12 weeks).

1.1 Dose 10 mg/day, BGP subscore care dependence (change from baseline at 12 weeks)

1

166

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐5.65, 1.65]

2 CGIC (numbers improved at 12 weeks) Show forest plot

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

3.30 [1.72, 6.33]
Analysis 4.2
Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 2 CGIC (numbers improved at 12 weeks).

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 2 CGIC (numbers improved at 12 weeks).

2.1 Dose 10mg/day

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

3.30 [1.72, 6.33]

3 Number of drop‐outs Show forest plot

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

1.03 [0.25, 4.25]
Analysis 4.3
Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 3 Number of drop‐outs.

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 3 Number of drop‐outs.

4 Number suffering at least one adverse event Show forest plot

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

1.03 [0.49, 2.16]
Analysis 4.4
Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 4 Number suffering at least one adverse event.

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 4 Number suffering at least one adverse event.

Open in table viewer
Comparison 5. Memantine vs placebo for dementia (cause not specified) (4‐6 weeks)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global Show forest plot

3

213

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.76 [‐1.04, ‐0.48]
Analysis 5.1
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 1 Global.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 1 Global.

1.1 Dose 30mg/day, Physicians global impression (6 weeks)

1

66

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.82 [‐1.33, ‐0.32]

1.2 Dose 30mg/day, SCAG Clinical global impression of disturbances (4 weeks)

1

59

Std. Mean Difference (IV, Fixed, 95% CI)

‐1.04 [‐1.58, ‐0.49]

1.3 Dose 20mg/day, CGI (6 weeks)

1

88

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.55 [‐0.98, ‐0.13]

2 Cognition Show forest plot

1

59

Mean Difference (IV, Fixed, 95% CI)

‐3.04 [‐5.68, ‐0.40]
Analysis 5.2
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 2 Cognition.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 2 Cognition.

2.1 Dose 30mg/day, SKT (change from baseline at 6 weeks)

1

59

Mean Difference (IV, Fixed, 95% CI)

‐3.04 [‐5.68, ‐0.40]

3 Activities of daily living Show forest plot

2

126

Std. Mean Difference (IV, Fixed, 95% CI)

‐1.34 [‐1.73, ‐0.94]
Analysis 5.3
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 3 Activities of daily living.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 3 Activities of daily living.

3.1 Dose 30mg/day, BGP care dependence subsscale (change from baseline at 6 weeks)

1

60

Std. Mean Difference (IV, Fixed, 95% CI)

‐2.05 [‐2.68, ‐1.42]

3.2 Dose 30mg/day, ADL‐test total time (6 weeks)

1

66

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.88 [‐1.39, ‐0.37]

4 Mood and behaviour Show forest plot

3

208

Std. Mean Difference (IV, Fixed, 95% CI)

‐1.16 [‐1.46, ‐0.86]
Analysis 5.4
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 4 Mood and behaviour.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 4 Mood and behaviour.

4.1 Dose 30mg/day, NOSIE (change from baseline at 4 weeks)

1

60

Std. Mean Difference (IV, Fixed, 95% CI)

‐2.02 [‐2.65, ‐1.39]

4.2 Dose 30mg/day, SCAG total (change from baseline at 6 weeks)

2

148

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.91 [‐1.25, ‐0.57]

5 Number of dropouts Show forest plot

2

154

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.27, 2.67]
Analysis 5.5
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 5 Number of dropouts.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 5 Number of dropouts.

6 Number suffering at least one adverse event Show forest plot

1

82

Odds Ratio (M‐H, Fixed, 95% CI)

2.00 [0.83, 4.81]
Analysis 5.6
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 6 Number suffering at least one adverse event.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 6 Number suffering at least one adverse event.

7 Number suffering agitation as an adverse event Show forest plot

1

59

Odds Ratio (M‐H, Fixed, 95% CI)

2.7 [0.48, 15.19]
Analysis 5.7
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 7 Number suffering agitation as an adverse event.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 7 Number suffering agitation as an adverse event.

8 Number suffering restlessness as an adverse event Show forest plot

1

59

Odds Ratio (M‐H, Fixed, 95% CI)

13.5 [2.71, 67.18]
Analysis 5.8
Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 8 Number suffering restlessness as an adverse event.

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 8 Number suffering restlessness as an adverse event.

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Comparison 6. Memantine vs placebo for mild to severe dementia. All published, 6 month studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: CIBIC+ or CGI‐C Show forest plot

8

3020

Stand. Tx effect (Fixed, 95% CI)

0.15 [0.07, 0.23]
Analysis 6.1
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 1 Clinical Global: CIBIC+ or CGI‐C.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 1 Clinical Global: CIBIC+ or CGI‐C.

2 Cognitive function: standardised Show forest plot

8

3070

Stand. Tx effect (Fixed, 95% CI)

0.24 [0.17, 0.30]
Analysis 6.2
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 2 Cognitive function: standardised.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 2 Cognitive function: standardised.

3 Activities of daily living: standardised Show forest plot

8

2791

Stand. Tx effect (Fixed, 95% CI)

0.08 [0.01, 0.15]
Analysis 6.3
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 3 Activities of daily living: standardised.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 3 Activities of daily living: standardised.

4 Behaviour and mood: standardised Show forest plot

8

2729

Stand. tx effect (Fixed, 95% CI)

0.11 [0.04, 0.19]
Analysis 6.4
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 4 Behaviour and mood: standardised.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 4 Behaviour and mood: standardised.

5 Number of dropouts Show forest plot

8

3212

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.76, 1.09]
Analysis 6.5
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 5 Number of dropouts.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 5 Number of dropouts.

6 Number suffering at least one adverse event Show forest plot

8

3211

Odds Ratio (M‐H, Fixed, 95% CI)

1.09 [0.93, 1.27]
Analysis 6.6
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 6 Number suffering at least one adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 6 Number suffering at least one adverse event.

7 Number suffering agitation as an adverse event Show forest plot

8

3612

Odds Ratio (M‐H, Fixed, 95% CI)

0.78 [0.61, 0.99]
Analysis 6.7
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 7 Number suffering agitation as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 7 Number suffering agitation as an adverse event.

8 Number suffering confusion as an adverse event Show forest plot

6

2489

Odds Ratio (M‐H, Fixed, 95% CI)

1.31 [0.93, 1.87]
Analysis 6.8
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 8 Number suffering confusion as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 8 Number suffering confusion as an adverse event.

9 Number suffering hypertension Show forest plot

1

350

Odds Ratio (M‐H, Fixed, 95% CI)

3.59 [1.16, 11.12]
Analysis 6.9
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 9 Number suffering hypertension.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 9 Number suffering hypertension.

10 Number suffering dizziness as an adverse event Show forest plot

6

2489

Odds Ratio (M‐H, Fixed, 95% CI)

1.18 [0.86, 1.60]
Analysis 6.10
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 10 Number suffering dizziness as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 10 Number suffering dizziness as an adverse event.

11 Number suffering headache as an adverse event Show forest plot

4

1765

Odds Ratio (M‐H, Fixed, 95% CI)

1.02 [0.67, 1.56]
Analysis 6.11
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 11 Number suffering headache as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 11 Number suffering headache as an adverse event.

12 Number suffering fall as an adverse event Show forest plot

6

2420

Odds Ratio (M‐H, Fixed, 95% CI)

0.96 [0.71, 1.30]
Analysis 6.12
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 12 Number suffering fall as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 12 Number suffering fall as an adverse event.

13 Number suffering insomnia as an adverse event Show forest plot

4

1614

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.59, 1.43]
Analysis 6.13
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 13 Number suffering insomnia as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 13 Number suffering insomnia as an adverse event.

14 Number suffering accidental injury as an adverse event Show forest plot

6

2308

Odds Ratio (M‐H, Fixed, 95% CI)

0.70 [0.50, 0.98]
Analysis 6.14
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 14 Number suffering accidental injury as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 14 Number suffering accidental injury as an adverse event.

15 Number suffering urinary incontinence as an adverse event Show forest plot

3

1234

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.67, 1.85]
Analysis 6.15
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 15 Number suffering urinary incontinence as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 15 Number suffering urinary incontinence as an adverse event.

16 Number suffering from diarrhoea as an adverse event Show forest plot

4

1584

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.56, 1.33]
Analysis 6.16
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 16 Number suffering from diarrhoea as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 16 Number suffering from diarrhoea as an adverse event.

17 Number suffering from influenza like symptoms as an adverse event Show forest plot

4

1589

Odds Ratio (M‐H, Fixed, 95% CI)

1.08 [0.72, 1.63]
Analysis 6.17
Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 17 Number suffering from influenza like symptoms as an adverse event.

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 17 Number suffering from influenza like symptoms as an adverse event.

Open in table viewer
Comparison 7. Memantine vs placebo for mild to severe dementia. All 4‐12 week studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: standardised Show forest plot

4

377

Stand. Tx effect (Fixed, 95% CI)

0.62 [0.41, 0.82]
Analysis 7.1
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 1 Clinical Global: standardised.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 1 Clinical Global: standardised.

2 Cognitive function: standardised Show forest plot

1

59

Stand. Tx effect (Fixed, 95% CI)

0.59 [0.11, 1.07]
Analysis 7.2
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 2 Cognitive function: standardised.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 2 Cognitive function: standardised.

3 Activities of daily living: standardised Show forest plot

3

292

Stand. Tx effect (Fixed, 95% CI)

0.73 [0.50, 0.96]
Analysis 7.3
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 3 Activities of daily living: standardised.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 3 Activities of daily living: standardised.

4 Mood and behaviour: standardised Show forest plot

3

208

Stand. Tx effect (Fixed, 95% CI)

1.27 [0.99, 1.54]
Analysis 7.4
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 4 Mood and behaviour: standardised.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 4 Mood and behaviour: standardised.

5 Number of drop‐outs Show forest plot

3

320

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.38, 2.23]
Analysis 7.5
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 5 Number of drop‐outs.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 5 Number of drop‐outs.

6 Number suffering at least one adverse event Show forest plot

2

248

Odds Ratio (M‐H, Fixed, 95% CI)

1.36 [0.77, 2.38]
Analysis 7.6
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 6 Number suffering at least one adverse event.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 6 Number suffering at least one adverse event.

7 Number suffering agitation as an adverse event Show forest plot

1

59

Odds Ratio (M‐H, Fixed, 95% CI)

2.7 [0.48, 15.19]
Analysis 7.7
Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 7 Number suffering agitation as an adverse event.

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 7 Number suffering agitation as an adverse event.

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 1 Clinical Global: CIBIC+ (24‐28 weeks).
Figuras y tablas -
Analysis 1.1

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 1 Clinical Global: CIBIC+ (24‐28 weeks).

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Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 2 Cognitive function: SIB (change from baseline at 24‐28 weeks).
Figuras y tablas -
Analysis 1.2

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 2 Cognitive function: SIB (change from baseline at 24‐28 weeks).

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Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 3 Activities of daily living: ADCS‐ADLsev19 (change from baseline at 24‐28 weeks).
Figuras y tablas -
Analysis 1.3

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 3 Activities of daily living: ADCS‐ADLsev19 (change from baseline at 24‐28 weeks).

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Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 4 Behaviour and mood: NPI total (change from baseline at 24‐28 weeks).
Figuras y tablas -
Analysis 1.4

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 4 Behaviour and mood: NPI total (change from baseline at 24‐28 weeks).

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Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 5 Number of dropouts.
Figuras y tablas -
Analysis 1.5

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 5 Number of dropouts.

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Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 6 Number suffering at least one adverse event.
Figuras y tablas -
Analysis 1.6

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 6 Number suffering at least one adverse event.

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Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 7 Number suffering agitation as an adverse event.
Figuras y tablas -
Analysis 1.7

Comparison 1 Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data., Outcome 7 Number suffering agitation as an adverse event.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 1 Clinical global: CIBIC+ (at 24 weeks).
Figuras y tablas -
Analysis 2.1

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 1 Clinical global: CIBIC+ (at 24 weeks).

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 2 Cognitive function: ADAS‐Cog (change from baseline at 24 weeks).
Figuras y tablas -
Analysis 2.2

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 2 Cognitive function: ADAS‐Cog (change from baseline at 24 weeks).

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 3 Activities of daily living: ADCS‐ADL23 (change from baseline at 24 weeks).
Figuras y tablas -
Analysis 2.3

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 3 Activities of daily living: ADCS‐ADL23 (change from baseline at 24 weeks).

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 4 Mood and behaviour: NPI total (change from baseline at 24 weeks).
Figuras y tablas -
Analysis 2.4

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 4 Mood and behaviour: NPI total (change from baseline at 24 weeks).

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 5 Number of dropouts.
Figuras y tablas -
Analysis 2.5

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 5 Number of dropouts.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 6 Number suffering agitation as an adverse event.
Figuras y tablas -
Analysis 2.6

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 6 Number suffering agitation as an adverse event.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 7 Number suffering fall as an adverse event.
Figuras y tablas -
Analysis 2.7

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 7 Number suffering fall as an adverse event.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 8 Number suffering somnolence as an adverse event.
Figuras y tablas -
Analysis 2.8

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 8 Number suffering somnolence as an adverse event.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 9 Number suffering confusion as an adverse event.
Figuras y tablas -
Analysis 2.9

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 9 Number suffering confusion as an adverse event.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 10 Number suffering at least one adverse event.
Figuras y tablas -
Analysis 2.10

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 10 Number suffering at least one adverse event.

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Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 11 Number suffering depression as an adverse event.
Figuras y tablas -
Analysis 2.11

Comparison 2 Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data, Outcome 11 Number suffering depression as an adverse event.

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Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 1 Clinical Global: CGI (at 28 weeks) ITT‐LOCF or OC.
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Analysis 3.1

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 1 Clinical Global: CGI (at 28 weeks) ITT‐LOCF or OC.

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Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 2 Cognitive function ADAS‐Cog (change from baseline at 28 weeks) ITT‐LOCF.
Figuras y tablas -
Analysis 3.2

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 2 Cognitive function ADAS‐Cog (change from baseline at 28 weeks) ITT‐LOCF.

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Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 3 Activities of daily living : NOSGER self care subscale (change from baseline at 28 weeks) OC.
Figuras y tablas -
Analysis 3.3

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 3 Activities of daily living : NOSGER self care subscale (change from baseline at 28 weeks) OC.

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Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 4 Behaviour: NOSGER disturbing behaviour subscale (change from baseline at 28 weeks) OC.
Figuras y tablas -
Analysis 3.4

Comparison 3 Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data, Outcome 4 Behaviour: NOSGER disturbing behaviour subscale (change from baseline at 28 weeks) OC.

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Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 1 Activities of daily living (change from baseline at 12 weeks).
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Analysis 4.1

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 1 Activities of daily living (change from baseline at 12 weeks).

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Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 2 CGIC (numbers improved at 12 weeks).
Figuras y tablas -
Analysis 4.2

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 2 CGIC (numbers improved at 12 weeks).

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Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 3 Number of drop‐outs.
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Analysis 4.3

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 3 Number of drop‐outs.

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Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 4 Number suffering at least one adverse event.
Figuras y tablas -
Analysis 4.4

Comparison 4 Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks), Outcome 4 Number suffering at least one adverse event.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 1 Global.
Figuras y tablas -
Analysis 5.1

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 1 Global.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 2 Cognition.
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Analysis 5.2

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 2 Cognition.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 3 Activities of daily living.
Figuras y tablas -
Analysis 5.3

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 3 Activities of daily living.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 4 Mood and behaviour.
Figuras y tablas -
Analysis 5.4

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 4 Mood and behaviour.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 5 Number of dropouts.
Figuras y tablas -
Analysis 5.5

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 5 Number of dropouts.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 6 Number suffering at least one adverse event.
Figuras y tablas -
Analysis 5.6

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 6 Number suffering at least one adverse event.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 7 Number suffering agitation as an adverse event.
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Analysis 5.7

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 7 Number suffering agitation as an adverse event.

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Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 8 Number suffering restlessness as an adverse event.
Figuras y tablas -
Analysis 5.8

Comparison 5 Memantine vs placebo for dementia (cause not specified) (4‐6 weeks), Outcome 8 Number suffering restlessness as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 1 Clinical Global: CIBIC+ or CGI‐C.
Figuras y tablas -
Analysis 6.1

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 1 Clinical Global: CIBIC+ or CGI‐C.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 2 Cognitive function: standardised.
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Analysis 6.2

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 2 Cognitive function: standardised.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 3 Activities of daily living: standardised.
Figuras y tablas -
Analysis 6.3

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 3 Activities of daily living: standardised.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 4 Behaviour and mood: standardised.
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Analysis 6.4

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 4 Behaviour and mood: standardised.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 5 Number of dropouts.
Figuras y tablas -
Analysis 6.5

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 5 Number of dropouts.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 6 Number suffering at least one adverse event.
Figuras y tablas -
Analysis 6.6

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 6 Number suffering at least one adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 7 Number suffering agitation as an adverse event.
Figuras y tablas -
Analysis 6.7

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 7 Number suffering agitation as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 8 Number suffering confusion as an adverse event.
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Analysis 6.8

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 8 Number suffering confusion as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 9 Number suffering hypertension.
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Analysis 6.9

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 9 Number suffering hypertension.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 10 Number suffering dizziness as an adverse event.
Figuras y tablas -
Analysis 6.10

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 10 Number suffering dizziness as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 11 Number suffering headache as an adverse event.
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Analysis 6.11

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 11 Number suffering headache as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 12 Number suffering fall as an adverse event.
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Analysis 6.12

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 12 Number suffering fall as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 13 Number suffering insomnia as an adverse event.
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Analysis 6.13

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 13 Number suffering insomnia as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 14 Number suffering accidental injury as an adverse event.
Figuras y tablas -
Analysis 6.14

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 14 Number suffering accidental injury as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 15 Number suffering urinary incontinence as an adverse event.
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Analysis 6.15

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 15 Number suffering urinary incontinence as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 16 Number suffering from diarrhoea as an adverse event.
Figuras y tablas -
Analysis 6.16

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 16 Number suffering from diarrhoea as an adverse event.

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Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 17 Number suffering from influenza like symptoms as an adverse event.
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Analysis 6.17

Comparison 6 Memantine vs placebo for mild to severe dementia. All published, 6 month studies, Outcome 17 Number suffering from influenza like symptoms as an adverse event.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 1 Clinical Global: standardised.
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Analysis 7.1

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 1 Clinical Global: standardised.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 2 Cognitive function: standardised.
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Analysis 7.2

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 2 Cognitive function: standardised.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 3 Activities of daily living: standardised.
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Analysis 7.3

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 3 Activities of daily living: standardised.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 4 Mood and behaviour: standardised.
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Analysis 7.4

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 4 Mood and behaviour: standardised.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 5 Number of drop‐outs.
Figuras y tablas -
Analysis 7.5

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 5 Number of drop‐outs.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 6 Number suffering at least one adverse event.
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Analysis 7.6

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 6 Number suffering at least one adverse event.

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Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 7 Number suffering agitation as an adverse event.
Figuras y tablas -
Analysis 7.7

Comparison 7 Memantine vs placebo for mild to severe dementia. All 4‐12 week studies, Outcome 7 Number suffering agitation as an adverse event.

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Table 1. Baseline characteristics of participants in the included studies

Study

Number randomized

Diagnosis

Severity of disease

Mean age (s.e.)

Mean MMSE (s.e.)

Mean SCAG (s.e.)

Mean ADAS‐Cog (s.e.)

% female

duration (weeks)

Ditzler 1991

66

AD (6%), VD (79%), MD (15%)

mild to moderate

72.2

63.3

65

6

Gortelmeyer 1992

88

AD (9%), VD (76%), MD (15%)

mild to moderate

71.5

24.1

64.2

68

6

9408/Orgogozo 2002

321

VD

mild to moderate

76.4 (6.7)

16.9 (2.5)

21.0 (9.1)

47

28

Pantev 1993

60

all dementias

mild to moderately severe

72.4 (5.7)

85.3 (3.8)

75

4

9605/Reisberg 2003

252

AD

moderately severe to severe

76.1(8.07)

7,9 (3,64)

67

28

9202/Wilcock 2002

579

VD

mild to moderate

77

17.6 (3.25)

48

28

Winblad 1999

167

AD (48%), VD + MD (52%)

severe

71.6 (5.6)

6.3 (2.7)

58

12

MD‐02/Tariot 2004

404

AD

moderate to severe

75.5

9,9 (3,13)

64,8

24

MD‐10/Peskind 2004

403

AD

mild to moderate

77.5 (7.8)

17.1 (3.6)

27.3 (10.6)

58.8

24

MD‐01

350

AD

moderate to severe

78.2 (7.9)

71.4

24

MD‐12

432

AD

mild to moderate

24

99679

470

AD

mild to moderate

26

MRZ‐9104

56

AD

13

MRZ‐9105

27

primary dementia

mild to severe

12

MRZ‐9206

56

VD

moderate to severe

77.5 (7.8)

M: 17.2 (3.4), P: 17.4 (3.7)

M: 27.3 (9.7) P: 27.2 (11)

58.8

14
Figuras y tablas -
Table 1. Baseline characteristics of participants in the included studies
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Table 2. Outcome measures

Study

ADAS‐Cog

SIB

ADCS‐ADL

ADL

BGP

CIBIC‐Plus

CGIC

NPI

Other

9202/Wilcock 2002

X

X

NOSGER

9408/Orgogozo 2000

X

X

X

GBS, MMSE, NOSGER

9403/Winblad 1999

X

X

9605/Reisberg 2003

X

X

X

X

FAST, SIB

Ditzler 1991

X

Physician's Global Impression, Syndrom Kurztest, SCAG

Gortelmeyer 1992

X

CGI, GBS, Tapping test, Trace test, SCAG

99679 (Lundbeck)

MD‐01

X

X

X

X

X

FAST, SIB

MD‐02/Tariot 2004

X

X

X

X

X

SIB

MD‐10/Peskind 2004

X

X

X

X

MD‐12

MRZ‐9104

MRZ‐9105

MRZ‐9206

Pantev 1993

X

Global assessment of clinical efficacy, NOSIE‐Index, Physician's global rating of tolerability, SCAG

Figuras y tablas -
Table 2. Outcome measures
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Comparison 1. Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data.

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: CIBIC+ (24‐28 weeks) Show forest plot

3

964

Mean Difference (IV, Fixed, 95% CI)

0.28 [0.15, 0.41]

2 Cognitive function: SIB (change from baseline at 24‐28 weeks) Show forest plot

3

976

Mean Difference (IV, Fixed, 95% CI)

2.97 [1.68, 4.26]

3 Activities of daily living: ADCS‐ADLsev19 (change from baseline at 24‐28 weeks) Show forest plot

3

978

Mean Difference (IV, Fixed, 95% CI)

1.27 [0.44, 2.09]

4 Behaviour and mood: NPI total (change from baseline at 24‐28 weeks) Show forest plot

3

936

Mean Difference (IV, Fixed, 95% CI)

2.76 [0.88, 4.63]

5 Number of dropouts Show forest plot

3

1006

Odds Ratio (M‐H, Fixed, 95% CI)

0.66 [0.49, 0.88]

6 Number suffering at least one adverse event Show forest plot

3

1005

Odds Ratio (M‐H, Fixed, 95% CI)

1.13 [0.84, 1.52]

7 Number suffering agitation as an adverse event Show forest plot

3

1005

Odds Ratio (M‐H, Fixed, 95% CI)

0.60 [0.42, 0.86]
Figuras y tablas -
Comparison 1. Memantine vs placebo for moderate‐to‐severe Alzheimer's disease. 6 month studies. ITT‐LOCF data.
Ir a la tabla de la revisión
Comparison 2. Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical global: CIBIC+ (at 24 weeks) Show forest plot

3

1281

Mean Difference (IV, Fixed, 95% CI)

0.13 [0.01, 0.25]

2 Cognitive function: ADAS‐Cog (change from baseline at 24 weeks) Show forest plot

3

1279

Mean Difference (IV, Fixed, 95% CI)

0.99 [0.21, 1.78]

3 Activities of daily living: ADCS‐ADL23 (change from baseline at 24 weeks) Show forest plot

3

1271

Mean Difference (IV, Fixed, 95% CI)

0.20 [‐0.87, 1.27]

4 Mood and behaviour: NPI total (change from baseline at 24 weeks) Show forest plot

3

1252

Mean Difference (IV, Fixed, 95% CI)

‐0.25 [‐1.48, 0.98]

5 Number of dropouts Show forest plot

3

1306

Odds Ratio (M‐H, Fixed, 95% CI)

1.16 [0.83, 1.60]

6 Number suffering agitation as an adverse event Show forest plot

3

1306

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.57, 1.46]

7 Number suffering fall as an adverse event Show forest plot

2

836

Odds Ratio (M‐H, Fixed, 95% CI)

0.83 [0.41, 1.67]

8 Number suffering somnolence as an adverse event Show forest plot

1

403

Odds Ratio (M‐H, Fixed, 95% CI)

7.49 [1.68, 33.38]

9 Number suffering confusion as an adverse event Show forest plot

2

836

Odds Ratio (M‐H, Fixed, 95% CI)

1.40 [0.72, 2.70]

10 Number suffering at least one adverse event Show forest plot

3

1306

Odds Ratio (M‐H, Fixed, 95% CI)

1.04 [0.81, 1.33]

11 Number suffering depression as an adverse event Show forest plot

2

836

Odds Ratio (M‐H, Fixed, 95% CI)

0.71 [0.38, 1.32]
Figuras y tablas -
Comparison 2. Memantine vs placebo for mild‐to‐moderate Alzheimer's disease. Published, 6 month studies. ITT‐LOCF data
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Comparison 3. Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: CGI (at 28 weeks) ITT‐LOCF or OC Show forest plot

2

775

Mean Difference (IV, Fixed, 95% CI)

0.03 [‐0.13, 0.19]

2 Cognitive function ADAS‐Cog (change from baseline at 28 weeks) ITT‐LOCF Show forest plot

2

815

Mean Difference (IV, Fixed, 95% CI)

1.85 [0.88, 2.83]

3 Activities of daily living : NOSGER self care subscale (change from baseline at 28 weeks) OC Show forest plot

2

542

Mean Difference (IV, Fixed, 95% CI)

0.12 [‐0.43, 0.67]

4 Behaviour: NOSGER disturbing behaviour subscale (change from baseline at 28 weeks) OC Show forest plot

2

541

Mean Difference (IV, Fixed, 95% CI)

0.48 [0.06, 0.91]
Figuras y tablas -
Comparison 3. Memantine vs placebo for mild‐to‐moderate vascular dementia. 6 month studies. LOCF or OC data
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Comparison 4. Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Activities of daily living (change from baseline at 12 weeks) Show forest plot

1

166

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐5.65, 1.65]

1.1 Dose 10 mg/day, BGP subscore care dependence (change from baseline at 12 weeks)

1

166

Mean Difference (IV, Fixed, 95% CI)

‐2.0 [‐5.65, 1.65]

2 CGIC (numbers improved at 12 weeks) Show forest plot

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

3.30 [1.72, 6.33]

2.1 Dose 10mg/day

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

3.30 [1.72, 6.33]

3 Number of drop‐outs Show forest plot

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

1.03 [0.25, 4.25]

4 Number suffering at least one adverse event Show forest plot

1

166

Odds Ratio (M‐H, Fixed, 95% CI)

1.03 [0.49, 2.16]
Figuras y tablas -
Comparison 4. Memantine vs placebo for severe Alzheimer disease, vascular and mixed dementia (12 weeks)
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Comparison 5. Memantine vs placebo for dementia (cause not specified) (4‐6 weeks)

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Global Show forest plot

3

213

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.76 [‐1.04, ‐0.48]

1.1 Dose 30mg/day, Physicians global impression (6 weeks)

1

66

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.82 [‐1.33, ‐0.32]

1.2 Dose 30mg/day, SCAG Clinical global impression of disturbances (4 weeks)

1

59

Std. Mean Difference (IV, Fixed, 95% CI)

‐1.04 [‐1.58, ‐0.49]

1.3 Dose 20mg/day, CGI (6 weeks)

1

88

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.55 [‐0.98, ‐0.13]

2 Cognition Show forest plot

1

59

Mean Difference (IV, Fixed, 95% CI)

‐3.04 [‐5.68, ‐0.40]

2.1 Dose 30mg/day, SKT (change from baseline at 6 weeks)

1

59

Mean Difference (IV, Fixed, 95% CI)

‐3.04 [‐5.68, ‐0.40]

3 Activities of daily living Show forest plot

2

126

Std. Mean Difference (IV, Fixed, 95% CI)

‐1.34 [‐1.73, ‐0.94]

3.1 Dose 30mg/day, BGP care dependence subsscale (change from baseline at 6 weeks)

1

60

Std. Mean Difference (IV, Fixed, 95% CI)

‐2.05 [‐2.68, ‐1.42]

3.2 Dose 30mg/day, ADL‐test total time (6 weeks)

1

66

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.88 [‐1.39, ‐0.37]

4 Mood and behaviour Show forest plot

3

208

Std. Mean Difference (IV, Fixed, 95% CI)

‐1.16 [‐1.46, ‐0.86]

4.1 Dose 30mg/day, NOSIE (change from baseline at 4 weeks)

1

60

Std. Mean Difference (IV, Fixed, 95% CI)

‐2.02 [‐2.65, ‐1.39]

4.2 Dose 30mg/day, SCAG total (change from baseline at 6 weeks)

2

148

Std. Mean Difference (IV, Fixed, 95% CI)

‐0.91 [‐1.25, ‐0.57]

5 Number of dropouts Show forest plot

2

154

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.27, 2.67]

6 Number suffering at least one adverse event Show forest plot

1

82

Odds Ratio (M‐H, Fixed, 95% CI)

2.00 [0.83, 4.81]

7 Number suffering agitation as an adverse event Show forest plot

1

59

Odds Ratio (M‐H, Fixed, 95% CI)

2.7 [0.48, 15.19]

8 Number suffering restlessness as an adverse event Show forest plot

1

59

Odds Ratio (M‐H, Fixed, 95% CI)

13.5 [2.71, 67.18]
Figuras y tablas -
Comparison 5. Memantine vs placebo for dementia (cause not specified) (4‐6 weeks)
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Comparison 6. Memantine vs placebo for mild to severe dementia. All published, 6 month studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: CIBIC+ or CGI‐C Show forest plot

8

3020

Stand. Tx effect (Fixed, 95% CI)

0.15 [0.07, 0.23]

2 Cognitive function: standardised Show forest plot

8

3070

Stand. Tx effect (Fixed, 95% CI)

0.24 [0.17, 0.30]

3 Activities of daily living: standardised Show forest plot

8

2791

Stand. Tx effect (Fixed, 95% CI)

0.08 [0.01, 0.15]

4 Behaviour and mood: standardised Show forest plot

8

2729

Stand. tx effect (Fixed, 95% CI)

0.11 [0.04, 0.19]

5 Number of dropouts Show forest plot

8

3212

Odds Ratio (M‐H, Fixed, 95% CI)

0.91 [0.76, 1.09]

6 Number suffering at least one adverse event Show forest plot

8

3211

Odds Ratio (M‐H, Fixed, 95% CI)

1.09 [0.93, 1.27]

7 Number suffering agitation as an adverse event Show forest plot

8

3612

Odds Ratio (M‐H, Fixed, 95% CI)

0.78 [0.61, 0.99]

8 Number suffering confusion as an adverse event Show forest plot

6

2489

Odds Ratio (M‐H, Fixed, 95% CI)

1.31 [0.93, 1.87]

9 Number suffering hypertension Show forest plot

1

350

Odds Ratio (M‐H, Fixed, 95% CI)

3.59 [1.16, 11.12]

10 Number suffering dizziness as an adverse event Show forest plot

6

2489

Odds Ratio (M‐H, Fixed, 95% CI)

1.18 [0.86, 1.60]

11 Number suffering headache as an adverse event Show forest plot

4

1765

Odds Ratio (M‐H, Fixed, 95% CI)

1.02 [0.67, 1.56]

12 Number suffering fall as an adverse event Show forest plot

6

2420

Odds Ratio (M‐H, Fixed, 95% CI)

0.96 [0.71, 1.30]

13 Number suffering insomnia as an adverse event Show forest plot

4

1614

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.59, 1.43]

14 Number suffering accidental injury as an adverse event Show forest plot

6

2308

Odds Ratio (M‐H, Fixed, 95% CI)

0.70 [0.50, 0.98]

15 Number suffering urinary incontinence as an adverse event Show forest plot

3

1234

Odds Ratio (M‐H, Fixed, 95% CI)

1.12 [0.67, 1.85]

16 Number suffering from diarrhoea as an adverse event Show forest plot

4

1584

Odds Ratio (M‐H, Fixed, 95% CI)

0.86 [0.56, 1.33]

17 Number suffering from influenza like symptoms as an adverse event Show forest plot

4

1589

Odds Ratio (M‐H, Fixed, 95% CI)

1.08 [0.72, 1.63]
Figuras y tablas -
Comparison 6. Memantine vs placebo for mild to severe dementia. All published, 6 month studies
Ir a la tabla de la revisión
Comparison 7. Memantine vs placebo for mild to severe dementia. All 4‐12 week studies

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Clinical Global: standardised Show forest plot

4

377

Stand. Tx effect (Fixed, 95% CI)

0.62 [0.41, 0.82]

2 Cognitive function: standardised Show forest plot

1

59

Stand. Tx effect (Fixed, 95% CI)

0.59 [0.11, 1.07]

3 Activities of daily living: standardised Show forest plot

3

292

Stand. Tx effect (Fixed, 95% CI)

0.73 [0.50, 0.96]

4 Mood and behaviour: standardised Show forest plot

3

208

Stand. Tx effect (Fixed, 95% CI)

1.27 [0.99, 1.54]

5 Number of drop‐outs Show forest plot

3

320

Odds Ratio (M‐H, Fixed, 95% CI)

0.92 [0.38, 2.23]

6 Number suffering at least one adverse event Show forest plot

2

248

Odds Ratio (M‐H, Fixed, 95% CI)

1.36 [0.77, 2.38]

7 Number suffering agitation as an adverse event Show forest plot

1

59

Odds Ratio (M‐H, Fixed, 95% CI)

2.7 [0.48, 15.19]
Figuras y tablas -
Comparison 7. Memantine vs placebo for mild to severe dementia. All 4‐12 week studies
Ir a la tabla de la revisión