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• W2029183641 abstract "<i>Background/Aims:</i> A 24-week, randomized, parallel-group, double-blind placebo-controlled study was conducted to evaluate the efficacy and tolerability of donepezil in severe Alzheimer’s disease (AD). <i>Methods:</i> Patients with severe AD (Mini-Mental State Examination score 1–12; modified Hachinski Ischemic Score ≤6; Functional Assessment Staging ≧6) were enrolled in this study in Japan. A total of 325 patients were randomized to donepezil 5 mg/day (n = 110), donepezil 10 mg/day (n = 103) or placebo (n = 112). Primary outcome measures were change from baseline to endpoint in the Severe Impairment Battery (SIB) and Clinician’s Interview-Based Impression of Change-plus caregiver input (CIBIC-plus) at the endpoint visit. <i>Results:</i> Donepezil 5 mg/day and 10 mg/day were significantly superior to placebo on the SIB, with a least-squares mean treatment difference of 6.7 and 9.0, respectively (p < 0.001 compared with placebo). CIBIC-plus analyses showed significant differences in favor of donepezil 10 mg/day over placebo at endpoint (p = 0.003). A statistically significant dose-response relationship was demonstrated with the SIB and CIBIC-plus. Donepezil was well tolerated. <i>Conclusion:</i> This study confirmed the effectiveness of donepezil 10 mg/day in patients with severe AD and demonstrated a significant dose-response relationship. Donepezil at dosages of both 5 mg/day and 10 mg/day is safe and well tolerated in Japanese patients with severe AD." @default.
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• W2029183641 date "2008-01-01" @default.
• W2029183641 modified "2023-10-18" @default.
• W2029183641 title "Donepezil Treatment of Patients with Severe Alzheimer’s Disease in a Japanese Population: Results from a 24-Week, Double-Blind, Placebo-Controlled, Randomized Trial" @default.
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• W2029183641 doi "https://doi.org/10.1159/000122961" @default.
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