Aricept late-stage study finds possible benefit, spurs debate
Donepezil (Aricept), a drug currently approved to treat mild to moderate Alzheimer’s disease, may also help nursing home residents with advanced disease, according to a study by Bengt Winblad and colleagues in the March 23 Lancet.
Compared with study participants receiving a placebo, those on donepezil scored somewhat better on various tests designed to assess the capabilities of individuals with severe Alzheimer’s. These tests measure such functions as memory, language, social interaction, eating, bathing, operating water taps, and turning on light switches.
The report has triggered debate about whether the higher scores seen with donepezil translate into any meaningful benefit for severely impaired individuals, their caregivers or their families. Contributing to the debate is the fact that the researchers in advance defined levels of score increases likely to indicate a real-world effect. The boost in scores did not meet those predefined thresholds, although they came close and were statistically significant.
An accompanying editorial by a doctor not involved in the research summarizes the practical, ethical and economic issues raised by the study.
“What this study demonstrates most compellingly is that late-stage Alzheimer’s is a devastating disease that raises terrible dilemmas,” says William H. Thies, Ph.D., Alzheimer’s Association vice president, medical and scientific relations. “There’s general agreement that treatment at this stage should focus on quality of life, but reasonable people may differ in how they define quality. Decisions are highly personal, and what people need is good, realistic, clearly presented information about risks and benefits of options. These issues also highlight the importance of creating advance directives to guide decision making, whenever possible.”
The average age of study participants was about 85 years, and the number of deaths in the donepezil and placebo groups was about the same. Last week, Eisai Co. Ltd., donepezil’s manufacturer, reported an excess number of deaths in the donepezil group in a study of the drug as a treatment for vascular dementia.





