A 24-week randomized, controlled trial of memantine in patients with moderate-to-severe Alzheimer disease

This study examined the efficacy and safety of memantine monotherapy in patients with moderate-to-severe Alzheimer disease (AD). Patients not receiving a cholinesterase inhibitor (N=350) were randomized to receive memantine (20 mg/d) or placebo during this 24-week, double-blind, placebo-controlled t...

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Bibliographic Details
Published in:	Alzheimer disease and associated disorders Vol. 21; no. 2; pp. 136 - 143
Main Authors:	VAN DVCK, Christopher H, TARIOT, Pierre N, MEVERS, Barnett, MALCA RESNICK, E
Format:	Journal Article
Language:	English
Published:	Hagerstown, MD Lippincott Williams & Wilkins 01-04-2007
Subjects:	Activities of Daily Living Aged Aged, 80 and over Alzheimer Disease - drug therapy Biological and medical sciences Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases Dopamine Agents - therapeutic use Double-Blind Method Female Humans Male Medical sciences Memantine - therapeutic use Middle Aged Neurology Neuropharmacology Neuropsychological Tests Pharmacology. Drug treatments Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease) Psychology. Psychoanalysis. Psychiatry Psychopharmacology Treatment Outcome Vascular diseases and vascular malformations of the nervous system Prognosis Cognitive disorder severe impairment battery Alzheimer disease Caregiver Esterases Glutamate receptor Incidence Complication Degenerative disease Antagonist Human Blind Nervous system diseases Enzyme Daily living Antialzheimer agent Antiparkinson agent Cholinesterase Carboxylic ester hydrolases Cerebral disorder Memantine Treatment Amantadine dérivatives Central nervous system disease Hydrolases post hoc analysis NMDA receptor Dementia
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Summary:	This study examined the efficacy and safety of memantine monotherapy in patients with moderate-to-severe Alzheimer disease (AD). Patients not receiving a cholinesterase inhibitor (N=350) were randomized to receive memantine (20 mg/d) or placebo during this 24-week, double-blind, placebo-controlled trial. Prospectively defined analyses failed to demonstrate a statistically significant benefit of memantine treatment compared with placebo on the Severe Impairment Battery (SIB) at week 24 end point, although a significant advantage was observed for memantine at weeks 12 and 18. The 19-item Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL19) did not differ significantly between groups in any analysis. Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-Plus) did not significantly favor memantine at week 24 despite a significant advantage for memantine at weeks 12 and 18. Other secondary outcomes showed no significant treatment differences. Post hoc analyses of potentially confounding covariates and alternative methods of imputing missing data did not substantially alter the results. Because of the violations of normality assumptions for the SIB and ADCS-ADL19, nonparametric analyses were performed; statistically significant benefit of memantine over placebo was demonstrated at week 24 for the SIB but not the ADCS-ADL19. The type and incidence of adverse events were similar in both groups.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 ObjectType-News-3 content type line 23
ISSN:	0893-0341 1546-4156
DOI:	10.1097/WAD.0b013e318065c495