The objective of this study was to assess the efficacy of donepezil in pati
ents with mild to moderate Alzheimer's disease (AD) in clinical practice. T
his was an open-label study in which patients were referred to an elderly m
ental health clinic in Southampton, UK. Eighty patients with mild to modera
te AD received 5 mg/day donepezil for the first 4 weeks, after which, if to
lerated, the dose was increased to 10 mg/day. Efficacy and safety assessmen
ts were carried out every 3 months. Efficacy was assessed by the Alzheimer'
s Disease Assessment Scale-cognitive subscale (ADAS-cog), Mini-Mental State
Examination (MMSE), Neuropsychiatric Inventory (NPI), Neuropsychiatric Inv
entory-carer Distress Scale (NPI-D). Mean improvements from baseline were o
bserved at the 3-month assessment on all four efficacy measures. At 3 month
s, 39% of patients showed an improvement of at least 4 points on the ADAS-c
og, and 37% of patients had improved by 4 points or more on the NPI. In tho
se patients who showed improvement and were maintained on donepezil, improv
ements were sustained for 18 months on the MMSE and NPI, 15 months on the N
PI-D, and for 6 months on the ADAS-cog. Six per cent of patients discontinu
ed medication due to adverse events. In a typical clinical practice setting
, patients with mild to moderate AD tolerated donepezil well. Clinically me
aningful improvements in cognitive function and a reduction in neuropsychia
tric symptoms were demonstrated in nearly 40% of patients with associated r
eduction in carer distress. Continued benefit was seen for up to 18 months
in the selected group of patients who initially responded to treatment. Cop
yright (C) 2000 John Wiley & Sons, Ltd.