Alzheimer's Drug Donepezil Maintains Activities of Daily Living
Benefits Shown Up to Year After Starting Therapy
By Aman Shah, MD
WebMD Medical News
Reviewed by Michael W. Smith, MD
Aug. 13, 2001 -- Two new studies show that the cholinesterase inhibitor donepezil (Aricept) can prolong the ability of Alzheimer's disease patients to continue to perform activities of daily living. The prospective, randomized, controlled studies, published in the Aug. 14 issue of Neurology, show that the benefits of the drug, which is already known to improve memory and language skills, extend at least a year after a patient starts taking it.
The lead author of one of the studies, Richard Mohs, PhD, tells WebMD, "Our study shifts the emphasis away from looking at acute improvement in memory and language to an emphasis on the preservation of functions that the patient came into treatment with. ... What it shows is that patients treated with donepezil are much less likely to experience a significant loss of function over a period of at least a year."
That's crucial, he says, because if patients begin treatment early, when they still have the ability to perform at a relatively high level of functioning, the drug may help them preserve that ability. "One of the things we have learned about this disease is that once a patient has lost some functional ability, it is very rare for that function to come back," says Mohs, associate chief of staff for research at the Bronx VA Medical Center and professor at the Mt. Sinai School of Medicine in New York.
In this study, 431 patients with probable Alzheimer's disease and a relatively high level of functioning on activities of daily living were randomly assigned to receive either placebo or donepezil (5 mg/day for 28 days and 10 mg/day after that) for up to 54 weeks.
Beginning at week 6, caregivers were asked to assess how well patients were able to perform the following basic activities of daily living: toileting, feeding, dressing, personal hygiene and grooming, bathing, and walking. The caregivers also assessed patients' ability to do household tasks such as using the telephone, managing money, and shopping.
The results showed that donepezil extended the median time to functional decline by 5 months compared to placebo. At 48 weeks, 51% of the donepezil group had no clinically evident functional decline compared to 35% of the placebo group. Overall, donepezil patients were 38% less likely to have a decline in functional ability.
In the second study, Bengt Winblad, MD, of the Karolinska Institutet in Stockholm, Sweden, and colleagues found similar results. They randomized 286 patients with possible or probable Alzheimer's disease to receive donepezil at the same dose as the Mohs et al. study or placebo and followed them for a year. Approximately two-thirds of the patients completed the study.
Both studies showed an acceptable side effect profile for donepezil, with between 7% and 11% discontinuing due to side effects, most of which were mild.
"It's good news for patients and their families," says Robert Daroff, MD, chief of staff at University Hospitals of Cleveland, Ohio, and editor-in-chief emeritus of the journal Neurology. "This drug will maintain its effectiveness beyond 6 months. Not only will memory and [thinking] skills be stabilized, but activities of daily living, which are so essential to independent function, also show less deterioration."
"When a really effective stabilizing drug is available, there will be more patients in a state of readiness to benefit," Daroff tells WebMD. "For clinicians, the study gives them something upon which to project hope when they talk to families and patients."