Donepezil in the treatment of Alzheimer's disease: long-term efficacy and safety.

OBJECTIVES: The aim of this study was to evaluate the long-term efficacy, safety and tolerability of donepezil in the treatment of Alzheimer's disease (AD). METHODS: Twenty-five patients (15 females and 10 males) with mild to moderate AD, according to DSM IV criteria, were recruited in the study. The principal efficacy measures were Alzheimer Disease Assessment Scale-cognitive subscale score (ADAS-cog), Mini Mental State Examination (MMSE) and Physical Self-Maintenance Scale (PSMS). Patients were treated with donepezil 5 mg/day for 1 month, after which an increase to 10 mg/day was encouraged. Evaluations were carried out prior to the start of the treatment and every 3 months for a period of 1 year. RESULTS: A significant improvement from baseline score of cognitive performances was seen through Week 24. Beginning with Week 36, performances declined relative to baseline, indicating continued disease progression. CONCLUSIONS: Donepezil improved cognition and global functioning and was well tolerated especially considered the long duration of the observation period.