TY - JOUR
T1 - Long-term donepezil treatment in 565 patients with Alzheimer's disease (AD2000): randomised double-blind trial
AU - Gray, Richard
AU - Bentham, Peter
AU - Hills, Robert
AU - Lendon, Corinne
AU - Raftery, J
AU - Brettell, Elizabeth
AU - Courtney, Carol
AU - Crome, P
AU - Edwards, Stephen
AU - Farrell, D
AU - Hardyman, W
AU - Fulcher, Leanne
AU - Shaw, H
PY - 2004/6/26
Y1 - 2004/6/26
N2 - BACKGROUND: Cholinesterase inhibitors produce small improvements in cognitive and global assessments in Alzheimer's disease. We aimed to determine whether donepezil produces worthwhile improvements in disability, dependency, behavioural and psychological symptoms, carers' psychological wellbeing, or delay in institutionalisation. If so, which patients benefit, from what dose, and for how long? METHODS: 565 community-resident patients with mild to moderate Alzheimer's disease entered a 12-week run-in period in which they were randomly allocated donepezil (5 mg/day) or placebo. 486 who completed this period were rerandomised to either donepezil (5 or 10 mg/day) or placebo, with double-blind treatment continuing as long as judged appropriate. Primary endpoints were entry to institutional care and progression of disability, defined by loss of either two of four basic, or six of 11 instrumental, activities on the Bristol activities of daily living scale (BADLS). Outcome assessments were sought for all patients and analysed by logrank and multilevel models. FINDINGS: Cognition averaged 0.8 MMSE (mini-mental state examination) points better (95% CI 0.5-1.2; p
AB - BACKGROUND: Cholinesterase inhibitors produce small improvements in cognitive and global assessments in Alzheimer's disease. We aimed to determine whether donepezil produces worthwhile improvements in disability, dependency, behavioural and psychological symptoms, carers' psychological wellbeing, or delay in institutionalisation. If so, which patients benefit, from what dose, and for how long? METHODS: 565 community-resident patients with mild to moderate Alzheimer's disease entered a 12-week run-in period in which they were randomly allocated donepezil (5 mg/day) or placebo. 486 who completed this period were rerandomised to either donepezil (5 or 10 mg/day) or placebo, with double-blind treatment continuing as long as judged appropriate. Primary endpoints were entry to institutional care and progression of disability, defined by loss of either two of four basic, or six of 11 instrumental, activities on the Bristol activities of daily living scale (BADLS). Outcome assessments were sought for all patients and analysed by logrank and multilevel models. FINDINGS: Cognition averaged 0.8 MMSE (mini-mental state examination) points better (95% CI 0.5-1.2; p
UR - http://www.scopus.com/inward/record.url?scp=3042567016&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(04)16499-4
DO - 10.1016/S0140-6736(04)16499-4
M3 - Article
C2 - 15220031
SN - 1474-547X
VL - 363
SP - 2105
EP - 2115
JO - Lancet
JF - Lancet
ER -