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Table of Contents
Vol. 10, No. 3, 1999
Issue release date: May–June 1999
Section title: Clinical Review
Dement Geriatr Cogn Disord 1999;10:237–244
(DOI:10.1159/000017126)

The Effects of Donepezil in Alzheimer’s Disease – Results from a Multinational Trial1

Burns A. · Rossor M. · Hecker J. · Gauthier S. · Petit H. · Möller H.-J. · Rogers S.L. · Friedhoff L.T.
aWithington Hospital, Manchester, UK; bThe Institute of Neurology, London, UK; cRepatriation General Hospital, Daw Park, Australia; dMcGill Center for Studies in Aging, Quebec, Canada; eUniversity of Lille, Lille, France; fLudwig-Maximilians-Universität, München, Germany; and gEisai Inc., Teaneck, N.J., USA

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Article / Publication Details

First-Page Preview
Abstract of Clinical Review

Published online: 5/11/1999

Number of Print Pages: 8
Number of Figures: 4
Number of Tables: 4

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM

Abstract

Donepezil has been shown to be well tolerated and to improve cognition and global function in patients with mild to moderately severe Alzheimer’s disease (AD). The current trial was undertaken to investigate further the efficacy and safety of donepezil, in a multinational setting, in patients with mild to moderately severe AD. This 30-week, placebo-controlled, parallel-group study consisted of a 24-week, double-blind treatment phase followed by a 6-week, single-blind, placebo washout. Eight hundred and eighteen patients with mild to moderately severe AD were randomly allocated to treatment with single, daily doses of 5 or 10 mg donepezil, or placebo. The two primary efficacy measures were: a cognitive performance test, the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and a global evaluation, the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC plus). Secondary outcome measures included the Sum of the Boxes of the Clinical Dementia Rating Scale (CDR-SB), a modified Interview for Deterioration in Daily living activities in Dementia (IDDD) and a patientrated quality of life assessment. Statistically significant improvements in cognitive and global function were observed, as evaluated by ADAS-cog and CIBIC plus, respectively, in both the 5 and 10 mg/day donepezil groups, compared with placebo. Treatment-associated changes were also observed in functional skills, as shown by improved scores on the CDR-SB and the complex-tasks component of the IDDD. A dose–response effect was evident, with the 10 mg/day donepezil group demonstrating greater benefits in all outcome measures than the 5 mg/day group. Donepezil was well tolerated by this patient population and did not produce any clinically significant laboratory test abnormalities. The results of this study confirm that donepezil is effective and well tolerated in treating the symptoms of mild to moderately severe AD.


  

Author Contacts

Medical Communications
Eisai Inc.
Glenpointe Centre West
500 Frank W. Burr Blvd.
Teaneck, NJ 07666-6741 (USA)

  

Article Information

Accepted: March 7, 1999
Number of Print Pages : 8
Number of Figures : 4, Number of Tables : 4, Number of References : 31

  

Publication Details

Dementia and Geriatric Cognitive Disorders

Vol. 10, No. 3, Year 1999 (Cover Date: May-June 1999)

Journal Editor: V. Chan-Palay, New York, N.Y.
ISSN: 1420–8008 (print), 1421–9824 (Online)

For additional information: http://www.karger.com/journals/dem


Article / Publication Details

First-Page Preview
Abstract of Clinical Review

Published online: 5/11/1999

Number of Print Pages: 8
Number of Figures: 4
Number of Tables: 4

ISSN: 1420-8008 (Print)
eISSN: 1421-9824 (Online)

For additional information: http://www.karger.com/DEM


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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