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Title: Long-Term Donepezil Not Associated with Reduced Institutionalisation or Progress of Disability in Patients with Alzheimer's Disease

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Lancet 2004;363:2105-15
06/25/2004 02:00:00 PM
By Joene Hendry

Patients with Alzheimer's disease who underwent long-term therapy with donepezil experienced small improvements in cognition and activities of daily living but did not see a reduction in the institutionalisation rate or the progress of disability compared with patients taking placebo, according to the findings of the AD2000 trial. A total of 565 community-residing patients with mild to moderate Alzheimer's disease, who had a regular carer, were not taking a cholinesterase inhibitor, and had no contraindications to donepezil therapy, participated in a 12-week run-in period that randomly assigned patients to either 5 mg/day donepezil or placebo. The 486 patients who completed the run-in phase underwent a second randomisation to either 5 mg/day or 10 mg/day donepezil, or placebo for as long as judged appropriate. For the primary endpoints of institutionalisation and progression of disability, as defined by a loss of either 2 or 4 basic, or 6 of 11 instrumental activities on the Bristol activities of daily living scale (BADLS), the 3 year assessment revealed institutionalisation in 42% of the donepezil patients compared with 44% of the placebo patients. Progression of disability occurred in 58% of the donepezil patients compared with 59% of the placebo group at 3 years. While cognition averaged 0.8 points better on the mini-mental state examination, and the functionality was 1.0 points better on the BADLS among patients taking donepezil compared with placebo at 2 years, the investigators identified no significant between group differences in behavioural and psychological symptoms, carer psychopathology, formal care costs, unpaid caregiver time, or according to treatment with 5 mg or 10 mg donepezil. Serious adverse events occurred in 29 donepezil patients and in 23 placebo patients ([P = .4), and deaths occurred in 63 and 50 patients, respectively, (P = .2), with 16 and 11 deaths, respectively, certified as dementia related. This trial consisted of "a fairly unselected group of patients with Alzheimer's disease who would be candidates for cholinesterase-inhibitor treatment in a clinical setting," the authors note. "The findings of the AD2000 trial accord with those of previous reports that donepezil produces small improvements in cognition and activities of daily living in patients with mild to moderate Alzheimer's disease," the AD2000 Collaborative Group authors write. However, "Donepezil produced no measurable reduction in rate of institutionalisation or progress of disability," they conclude, adding "more effective medical or non-medical treatments than cholinesterase inhibitors are needed for Alzheimer's disease."

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