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From the Alzheimer's Disease and Memory Disorders Center (R.S.D.), Baylor College of Medicine, Houston, TX; Alzheimer's Disease Center (S.H.F.), Silberstein Institute, New York University School of Medicine, New York, and Nathan Kline Institute, Orangeburg, NY; Memory and Aging Program (S.S.), Butler Hospital, Warren Alpert Medical School, Brown University, Providence, RI; Eisai Inc. (Y.S., A.K.M.), Woodcliff Lake, NJ; Pfizer Inc. (R.G., Y.X.), New York, NY; and PAREXEL (W.E.W.), Stamford, CT.
Background: Treatment of mild cognitive impairment (MCI) with cholinesterase inhibitors may improve symptoms.
Methods: In this multicenter, randomized, placebo-controlled trial, subjects with MCI entered a 3-week placebo run-in period followed by 48 weeks of double-blind donepezil (5 mg/day for 6 weeks, then 10 mg/day for 42 weeks) or placebo treatment. Primary efficacy variables included change from baseline in the modified Alzheimer Disease Assessment Scale–cognitive subscale (ADAS-Cog) and Clinical Dementia Rating Scale–sum of boxes (CDR-SB) after 48 weeks of treatment (modified intention-to-treat analysis). Secondary efficacy measures evaluated cognition, behavior, and function.
Results: The dual primary efficacy endpoint was not reached. We noted a small, but significant, decrease in modified ADAS-Cog scores in favor of donepezil at study endpoint. Little change from baseline in CDR-SB and secondary variables was observed for either group. Patient Global Assessment scores favored donepezil at all time points except week 12 (p 
0.05). Perceived Deficits Questionnaire scores favored donepezil at week 24 (p = 0.05). Clinical Global Impression of Change–MCI scores favored donepezil only at week 6 (p = 0.04). Adverse events were generally mild or moderate. More donepezil-treated subjects (18.4%) discontinued treatment due to adverse events than placebo-treated subjects (8.3%).
Conclusions: Donepezil demonstrated small but significant improvement on the primary measure of cognition but there was no change on the primary measure of global function. Most other measures of global impairment, cognition, and function were not improved, possibly because these measures are insensitive to change in MCI. Responses on subjective measures suggest subjects perceived benefits with donepezil treatment.
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