Functional, Cognitive and Behavioral Effects of Donepezil in Patients with Moderate Alzheimer's Disease

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Abstract
SummaryObjective: To investigate the efficacy and safety of donepezil in a subgroup of patients with Alzheimer's disease (AD) of moderate severity from a previous trial.Methods: Two hundred and seven patients with moderate AD (standardized Mini-Mental State Examination [sMMSE] score 10-17) were randomized to treatment in this 24-week, double-blind, placebo-controlled trial. Patients received either donepezil, 5mg/day for the first 28 days and 10mg/day thereafter according to the clinician's judgement (n = 102), or placebo (n = 105). The primary outcome measure was the Clinician's Interview-Based Impression of Change with caregiver input (CIBIC-plus) at week 24 using a last observation carried forward (LOCF) analysis.Results: Baseline patient demographics were similar between treatment groups. Mean age was 74.3 years (range 48–92). Least-squares (LS) mean sMMSE scores at baseline were 13.6 ± 0.3 for the donepezil group and 13.9 ± 0.3 for the placebo group. LS meanCIBIC-plus scores for donepezil-treated pat...