| Efficacy of donepezil in early-stage Alzheimer disease: a randomized placebo-controlled trial. | |
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MedLine Citation:
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PMID: 15596605 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To evaluate the efficacy of donepezil in patients with early-stage Alzheimer disease. DESIGN: Multicenter, randomized, double-blind, 24-week, placebo-controlled study that enrolled patients with early-stage Alzheimer disease. Patients were randomized in an approximately 2:1 ratio to donepezil, 5 mg/d, for the first 6 weeks, with a forced escalation to 10 mg/d thereafter (n = 96), or placebo (n = 57). The primary efficacy measure was the modified Alzheimer Disease Assessment Scale-cognitive subscale. Secondary efficacy measures included the Mini-Mental State Examination, the Computerized Memory Battery Test, the Clinical Dementia Rating Scale-Sum of the Boxes, the Patient Global Assessment Scale, and the Apathy Scale. RESULTS: Improvements favoring donepezil on the Alzheimer Disease Assessment Scale-cognitive subscale were found at weeks 12 and 24 and at the end point (last observation carried forward); treatment differences were 1.9 (P = .03), 2.3 (P = .008), and 2.3 (P = .001) points, respectively. Improvements favoring donepezil on the Mini-Mental State Examination were found at weeks 6, 12, and 24 and at the end point (last observation carried forward); treatment differences were 1.4 (P = .02), 1.2 (P = .04), 1.4 (P = .03), and 1.8 (P = .002) points, respectively. Donepezil-treated patients showed greater mean improvement compared with placebo-treated patients on the following Computerized Memory Battery Test subscales: facial recognition (P = .007 in the intent-to-treat population and P = .04 in the fully evaluable population), first and last name total acquisition (P = .02), and name-face association delayed recall (P = .04). Donepezil was safe and well tolerated in this population; serious adverse events occurred in similar numbers of donepezil- and placebo-treated patients. CONCLUSION: These data suggest significant treatment benefits of donepezil in early-stage Alzheimer disease, supporting the initiation of therapy early in the disease course to improve daily cognitive functioning. |
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Authors:
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Ben Seltzer; Parvaneh Zolnouni; Margarita Nunez; Robert Goldman; Dinesh Kumar; John Ieni; Sharon Richardson; |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Archives of neurology Volume: 61 ISSN: 0003-9942 ISO Abbreviation: Arch. Neurol. Publication Date: 2004 Dec |
Date Detail:
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Created Date: 2004-12-14 Completed Date: 2005-01-11 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0372436 Medline TA: Arch Neurol Country: United States |
Other Details:
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Languages: eng Pagination: 1852-6 Citation Subset: AIM; IM |
Affiliation:
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Department of Psychiatry and Neurology, Tulane University School of Medicine, 1430 Tulane Avenue, New Orleans, LA 70112-2699, USA. seltzer@tulane.edu |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Alzheimer Disease / drug therapy*, psychology Chi-Square Distribution Double-Blind Method Female Gastrointestinal Diseases / chemically induced Humans Indans / adverse effects, therapeutic use* Male Middle Aged Piperidines / adverse effects, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Indans; 0/Piperidines; 120011-70-3/donepezil |
| Comments/Corrections | |
Erratum In:
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Arch Neurol. 2005 May;62(5):825 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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