Efficacy of Donepezil on Behavioral Symptoms in Patients With Moderate to Severe Alzheimer's Disease

International Psychogeriatrics - Tập 14 Số 4 - Trang 389-404 - 2002
Serge Gauthier1, Howard Feldman2, Jane Hecker3, Bruno Vellas4, David Ames5, Ponni Subbiah6, Edward Whalen7, Birol Emir8
1Alzheimer's Disease Research Unit, McGill Centre for Studies in Aging, Verdun, Canada
2Division of Neurology, UBC Hospital, Clinic for Alzheimer's Disease and Related Disorders, Vancouver, Canada
3Department of Rehabilitation and Aged Care, Repatriation General Hospital, Daw Park, Australia
4Toulouse
University Alzheimer's Center, Toulouse, France;
5University of Melbourne, Department of Psychiatry, Royal Melbourne Hospital, Parkville, Australia
6CNS, Pfizer Pharmaceuticals Group, Pfizer Inc., New York, New York, US.
7Biometrics Department, Pfizer Pharmaceuticals Group, Pfizer Inc., New York, New York, US.
8Clinical Data Operations, Pfizer Pharmaceuticals Group, Pfizer Inc., New York, New York, US.

Tóm tắt

Objective: This subanalysis of a large, double-blind, placebo-controlled trial examined the prevalence of behavioral symptoms in moderate to severe Alzheimer's disease (AD), and the effect of treatment with donepezil. Methods: Two hundred ninety patients with moderate to severe AD (standardized Mini-Mental State Examination scores 5–17) were randomized to receive 24 weeks of once-daily doses of donepezil 5 mg/day for 28 days, and 10 mg/day thereafter per the clinician's judgment (n = 144), or placebo (n = 146). The outcome measure of interest was the 12-item Neuropsychiaric Inventory (NPI). Results: Baseline demographics were similar between the treatment groups. Least squares mean (± SE) baseline NPI 12-item total scores were 19.55 ± 1.48 and 19.30 ± 1.45, respectively. At baseline, the most common symptoms were apathy/indifference (67%), aberrant motor behavior (53%), depression/dysphoria (52%), anxiety (49%), and agitation/aggression (45%). NPI individual item change from baseline scores at Week 24 using a last observation carried forward (LOCF) analysis showed benefits with donepezil treatment compared with placebo for all items, with significant treatment differences for depression/dysphoria, anxiety, and apathy/indifference (p < .05). Symptoms present at baseline that improved significantly for donepezil- compared with placebo-treated patients at Week 24 LOCF included anxiety, apathy/indifference, and irritability/lability (p < .05). When patients who were not receiving psychoactive medications at baseline were analyzed separately, significant improvements in NPI 12-item total score were observed with donepezil compared with placebo at most visits and at Week 24 LOCF (p < .05). Conclusions: Behavioral symptoms of the magnitude observed in this moderate to severe AD population improved with donepezil.

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International Psychogeriatrics

Tập 14 Số 4

389-404

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