The New England Journal of Medicine has published the results of a study that examined the efficacy of donepezil in the treatment of behavioural disturbance in patients with Alzheimer's disease (AD).
The study recruited 272 patients with AD and clinically significant agitation. 259 patients were randomly assigned to treatment with donepezil 10mg per day (n = 128) or placebo (n = 131) for a period of 12 weeks. Patients were assessed for a change in score on the Cohen-Mansfield Agitation Inventory (CMAI).
20.4% (22/108) of patients in the placebo group and 19.5% (22/113) in the donepezil group had a 30% or greater reduction in their CMAI score. The difference was not significant. There were also no significant differences in the several other assessments: Neuropsychiatric Inventory, the Neuropsychiatric Inventory Caregiver Distress Scale and the Clinician's Global Impression of Change.
Action: Neuroleptic drugs are commonly used to treat agitation in AD but have known adverse effects. Donepezil would appear to be ineffective and should not be used as an alternative.