To determine the efficacy of Donepezil in the treatment of behavioural and psychological symptoms of dementia in patients with Alzheimer's disease (AD).
Design: A multi-centre, randomised, double-Blind, placebo-controlled study
Materials andMmethods: Patients with mild-to-moderate AD,attending 16 memory clinics in the UK, with significant BPSD (defined as NPI scores at baseline > 11 points) were treated with open label 5mg donepezil for 6 weeks followed by open label 10mg donepezil for a further 6 weeks. Patients were then randomized to placebo or 10mg donepezil on a 3:2 ratio for a further 6 weeks. Providing there was no significant cognitive deterioration, then treatment with placebo or 10mg donepezil was continued for a further 6 weeks. Patients were assessed at baseline and at weekly intervals throughout the study for the presence of BPSD using the NPI (10 items)and with the MMSE.
Results: A total of 134 patients participated. The frequency of patients with symptoms of delusions, hallucinations, agitation, anxiety and depression was significantly (all p < 0.05 after Bonferonni correction)lower following 12 weeks treatment with open label donepezil compared with the frequency of patients with these symptoms at baseline. Following randomization, those patients that continued on donepezil (10mg) for a further 12 weeks also showed further BPSD improvements with further significant reductions in the frequency of patients with symptoms of irritability and motor hyperactivity and continued improvement in symptoms of delusions, agitation and anxiety compared with baseline frequencies. Patients allocated to placebo showed increased frequencies, or did not show any significant improvement in these symptoms following randomization.
Conclusions: Donepezil has significant efficacy in the treatment of BPSD in patients with mild to moderate AD.
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