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Donepezil no better than placebo to treat behavioural symptoms of Alzheimer's

Published on October 4, 2007 at 9:10 PM · No Comments

New research has found that donepezil (known commercially as Aricept) is no more effective than a placebo at tackling the agitation which often accompanies Alzheimer's disease.

The findings, published in the New England Journal of Medicine, result from the CALM-AD trial which was set up by the Medical Research Council to look into the potential use of donepezil, to address the behavioural symptoms associated with Alzheimer's disease. Donepezil is part of a family of drugs called cholinesterase inhibitors which are primarily used to help enhance cognitive function.

A significant proportion of Alzheimer's patients suffer from behavioural disturbances which are particularly distressing for both patients and their caregivers. Amongst the most troubling of these are symptoms grouped under the term ‘agitation' which lead patients to pace, wander, shout or become aggressive. These symptoms are particularly hard to manage, both in the home and in residential care settings and have traditionally been addressed by sedation through the use of tranquilisers.

The team of UK researchers, led by Professor Robert Howard of the Institute of Psychiatry, King's College London, are keen to find effective and acceptable alternatives to the use of tranquillising medication in the treatment of these symptoms. The trial began by comparing the efficacy of risperidone (a major tranquilliser commonly used to treat agitated behaviour in Alzheimer's disease) with donepezil and a placebo in a group of almost 300 Alzheimer patients with severely agitated behaviour. During the course of the trial however, the Committee for the Safety of Medicines issued guidance warning that drugs like risperidone should not be given to Alzheimer's patients because of an increased incidence of stroke seen in patients taking them. The participants in the tranquiliser branch of the trial were immediately taken off the drugs and the trial continued as a comparison of donepezil against placebo.

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