A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Alzheimer's disease. Donepezil Study Group.

Abstract:

:The efficacy and safety of donepezil as a treatment for patients with mild to moderate Alzheimer's disease (AD) was investigated in a multicenter, double-blind study. Patients were randomly assigned to treatment with placebo (n = 162), 5 mg/d donepezil (n = 154), or 10 mg/d donepezil (n = 157) for 24 weeks followed by a 6-week, single-blind placebo washout. The primary efficacy measures were the cognitive portion of the Alzheimer's Disease Assessment Scale (ADAS-cog) and the Clinician's Interview Based Assessment of Change-Plus (CIBIC plus), with the Mini-Mental State Examination (MMSE), Clinical Dementia Rating Scale-Sum of the Boxes (CDR-SB), and patient rated Quality of Life (QoL) used as secondary measures. Cognitive function, as measured by the ADAS-cog, was significantly improved in the 5- and 10-mg/d donepezil groups as compared with the placebo group at weeks 12, 18, and 24. Clinician's global ratings on the CIBIC plus also improved in both the 5- and 10-mg/d donepezil groups relative to placebo. At the end of the 6-week placebo washout phase, ADAS-cog scores and CIBIC plus ratings were not significantly different for the three groups. Significant treatment benefits were also observed consistently in both the 5- and 10-mg/d groups on the MMSE and the CDR-SB, but there was no consistent effect on the patient-rated QoL. Cholinergic side effects (primarily diarrhea, nausea, and vomiting) were reported more often in the 10-mg/d group than either the 5-mg/d or placebo groups. Side effects were transient and generally mild in severity. These data indicate that donepezil is a well-tolerated drug that improves cognition and global function in patients with mild to moderate AD.

journal_name

Neurology

journal_title

Neurology

authors

Rogers SL,Farlow MR,Doody RS,Mohs R,Friedhoff LT

doi

10.1212/wnl.50.1.136

subject

Has Abstract

pub_date

1998-01-01 00:00:00

pages

136-45

issue

1

eissn

0028-3878

issn

1526-632X

journal_volume

50

pub_type

临床试验,杂志文章,多中心研究,随机对照试验
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    authors: Smith DB,Sidman RD,Flanigin H,Henke J,Labiner D

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    pub_type: 杂志文章,meta分析

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    journal_title:Neurology

    pub_type: 杂志文章,评审

    doi:

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    更新日期:1995-03-01 00:00:00

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    pub_type: 杂志文章,随机对照试验

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    更新日期:2007-07-03 00:00:00

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    doi:10.1212/wnl.47.3.827

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    更新日期:1996-09-01 00:00:00

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    pub_type: 杂志文章

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    pub_type: 临床试验,杂志文章,随机对照试验

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