Journal
NEUROLOGY
Volume 76, Issue 17, Pages 1500-1507Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1212/WNL.0b013e318218107a
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Funding
- NIH [2 R01 HD38107]
- National Center for Research Resources [M01 RR10710]
- Biogen Idec
- EMD Serono, Inc.
- Acorda Therapeutics Inc.
- BioMS Medical
- Teva Pharmaceutical Industries Ltd.
- Novartis
- Genentech, Inc.
- National Multiple Sclerosis Society
- Montel Williams Foundation
- Lourie Foundation
- Slomo and Cindy Silvian Foundation
- Cephalon, Inc.
- Shire plc
- Actelion Pharmaceuticals Ltd
- Avanir Pharmaceuticals
- Bayer Schering Pharma
- Genzyme Corporation
- Pfizer Inc
- sanofi-aventis
- Cyberonics, Inc.
- NIH/NINDS
- Merck Serono
- US Department of Defense
- Dartmouth Center for Clinical and Translational Science
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Objectives: The goal of this study was to determine if memory would be improved by donepezil as compared to placebo in a multicenter, double-blind, randomized clinical trial (RCT). Methods: Donepezil 10 mg daily was compared to placebo to treat memory impairment. Eligibility criteria included the following: age 18-59 years, clinically definite multiple sclerosis (MS), and performance <= 1/2 SD below published norms on the Rey Auditory Verbal Learning Test (RAVLT). Neuropsychological assessments were performed at baseline and 24 weeks. Primary outcomes were change on the Selective Reminding Test (SRT) of verbal memory and the participant's impression of memory change. Secondary outcomes included changes on other neuropsychological tests and the evaluating clinician's impression of memory change. Results: A total of 120 participants were enrolled and randomized to either donepezil or placebo. No significant treatment effects were found between groups on either primary outcome of memory or any secondary cognitive outcomes. A trend was noted for the clinician's impression of memory change in favor of donepezil (37.7%) vs placebo (23.7%) (p = 0.097). No serious or unanticipated adverse events attributed to study medication developed. Conclusions: Donepezil did not improve memory as compared to placebo on either of the primary outcomes in this study. Classification of evidence: This study provides Class I evidence which does not support the hypothesis that 10 mg of donepezil daily for 24 weeks is superior to placebo in improving cognition as measured by the SRT in people with MS whose baseline RAVLT score was 0.5 SD or more below average. Neurology (R) 2011;76:1500-1507
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