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Reference: Howard, RJ, Juszczak, E, Ballard, CG et al., (2007). Donepezil for the treatment of agitation in Alzheimer's disease. The New England journal of medicine, 357 (14), 1382-1392.Citable link to this page:


Donepezil for the treatment of agitation in Alzheimer's disease.

Abstract: BACKGROUND: Agitation is a common and distressing symptom in patients with Alzheimer's disease. Cholinesterase inhibitors improve cognitive outcomes in such patients, but the benefits of these drugs for behavioral disturbances are unclear. METHODS: We randomly assigned 272 patients with Alzheimer's disease who had clinically significant agitation and no response to a brief psychosocial treatment program to receive 10 mg of donepezil per day (128 patients) or placebo (131 patients) for 12 weeks. The primary outcome was a change in the score on the Cohen-Mansfield Agitation Inventory (CMAI) (on a scale of 29 to 203, with higher scores indicating more agitation) at 12 weeks. RESULTS: There was no significant difference between the effects of donepezil and those of placebo on the basis of the change in CMAI scores from baseline to 12 weeks (estimated mean difference in change [the value for donepezil minus that for placebo], -0.06; 95% confidence interval [CI], -4.35 to 4.22). Twenty-two of 108 patients (20.4%) in the placebo group and 22 of 113 (19.5%) in the donepezil group had a reduction of 30% or greater in the CMAI score (the value for donepezil minus that for placebo, -0.9 percentage point; 95% CI, -11.4 to 9.6). There were also no significant differences between the placebo and donepezil groups in scores for the Neuropsychiatric Inventory, the Neuropsychiatric Inventory Caregiver Distress Scale, or the Clinician's Global Impression of Change. CONCLUSIONS: In this 12-week trial, donepezil was not more effective than placebo in treating agitation in patients with Alzheimer's disease. ( number, NCT00142324 [].).

Peer Review status:Peer reviewedPublication status:PublishedVersion:Publisher's version Funder: Medical Research Council   Funder: Alzheimer's Society   Notes:From New England Journal of Medicine, Robert J. Howard, Edmund Juszczak, Clive G. Ballard, Peter Bentham, Richard G. Brown, Roger Bullock, Alistair S. Burns, Clive Holmes, Robin Jacoby, Tony Johnson, Martin Knapp, James Lindesay, John T. O'Brien, Gordon Wilcock, Cornelius Katona, Roy W. Jones, Julia DeCesare, Michaela Rodger, Donepezil for the Treatment of Agitation in Alzheimer's Disease, 357, 1382-1392. Copyright © 2007 Massachusetts Medical Society. Reprinted with permission.

Bibliographic Details

Publisher: Massachusetts Medical Society

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Journal: The New England journal of medicinesee more from them

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Issue Date: 2007-10


Urn: uuid:7c793175-5022-4a6a-be4e-43efe035946e

Source identifier: 60824

Eissn: 1533-4406


Issn: 0028-4793 Item Description

Type: Journal article;

Language: eng

Version: Publisher's versionKeywords: CALM-AD Trial Group Humans Alzheimer Disease Psychomotor Agitation Piperidines Indans Cholinesterase Inhibitors Treatment Failure Double-Blind Method Psychotherapy Social Support Aged Aged, 80 and over Female Male Tiny URL: pubs:60824


Autor: Howard, RJ - - - Juszczak, E - institutionUniversity of Oxford Oxford, MSD, Nuffield Department of Population Health, NPEU - - -



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