An independent study published in The Lancet suggests thatEisai/Pfizer's blockbuster Aricept (donepezil) is only minimally-effective in the treatment of Alzheimer's disease and therefore not a cost-effective therapy for the condition.
The AD2000 trial, conducted by scientists at Birmingham University in the UK, involved 565 community-resident patients with mild-to-moderate AD who entered a 12-week run-in period in which they were randomized to receive donepezil (5mg/day) or placebo. Of these, 486 completed this part of the study and were re-randomized to either donepezil (5mg/day or 10mg/day) or placebo, with double-blind treatment continuing as long as thought appropriate, noted the researchers.
The primary endpoints of the trial 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). Secondary outcome measures included: functional ability (BADLS: range 0-60); cognition, as measured by the mini-mental state examination (MMSE); presence and severity of behavioral and psychological symptoms and signs of dementia, assessed by the neuropsychiatric inventory; and safety.
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