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Published online before print July 21, 2006, 10.1097/01.JGP.0000224350.82719.83
Am J Geriatr Psychiatry 14:704-715, August 2006
© 2006 American Association for Geriatric Psychiatry
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Article

Memantine Treatment in Mild to Moderate Alzheimer Disease: A 24-Week Randomized, Controlled Trial

Elaine R. Peskind, M.D., Steven G. Potkin, M.D., Nunzio Pomara, M.D., Brian R. Ott, M.D., Stephen M. Graham, Ph.D., Jason T. Olin, Ph.D., Scott McDonald, Ph.D. for the Memantine MEM-MD-10 Study Group

From the Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine and Veterans Affairs Northwest Network Mental Illness Research, Education, and Clinical Center, Seattle, WA (ERP); Department of Psychiatry and Human Behavior, University of California, Irvine, CA (SGP); Nathan S. Kline Institute for Psychiatric Research (NP); Department of Clinical Neurosciences, Brown University (BRO); and Forest Research Institute, Jersey City, NJ (SMG, JTO, SM).

Objective: The objective of this study was to compare the efficacy and safety of the moderate-affinity, uncompetitive N-methyl-d-aspartate receptor antagonist, memantine, versus placebo in patients with mild to moderate Alzheimer disease (AD).

Method: This was a randomized, double-blind, placebo-controlled clinical trial conducted at 42 U.S. sites. Participants were 403 outpatients with mild to moderate AD and Mini-Mental State Examination scores of 10–22 randomized to memantine (20 mg/day; N=201) or placebo (N=202) for 24 weeks. Primary outcomes were change from baseline at 24 weeks on the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-cog), a measure of cognition, and on the Clinician’s Interview-Based Impression of Change Plus Caregiver Input (CIBIC-Plus), a global measure. Secondary outcomes included change on the Neuropsychiatric Inventory (NPI) and the Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL23), measures of behavior and function, respectively.

Results: Most (82.4%) participants completed the trial. Memantine resulted in significantly better outcomes than placebo on measures of cognition, global status, and behavior when based on the protocol-specified primary last observation carried forward imputation as well as a mixed-models repeated-measures approach applied to the continuous outcomes. Treatment discontinuations because of adverse events for memantine versus placebo were 19 (9.5%) and 10 (5.0%), respectively.

Conclusions: These results support the safety and efficacy of memantine for the treatment of mild to moderate AD.

Key Words: Memantine • Alzheimer disease • dementia






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