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.