Donepezil

DALLAS -- Donepezil preserves the ability to perform both basic and complex activities of daily living in patients with Alzheimer's disease, Dr. John R. Ieni reported at the annual meeting of the American Academy of Family Physicians.

He presented the results of a 1-year placebo-controlled double-blind study involving 431 patients with Alzheimer's disease. Unlike prior studies of donepezil (Aricept) that focused on cognition, this trial assessed preservation of functional ability.

Donepezil is approved and in widespread clinical use for improvement of cognition in patients with mild to moderate Alzheimer's disease. But this new finding that donepezil-treated patients also had significantly less impairment of functional skills has important clinical, social, and economic implications. It suggests that treatment with the cholinesterase inhibitor should reduce the burden on caregivers and help postpone the need for nursing home placement, said Dr. Ieni of Eisai Inc., Teaneck, N.J., the company that sponsored the study along with Pfizer Inc.

Donepezil-treated patients maintained their activities of daily living 72% longer--5 months--than those on placebo. The median time to clinically evident functional decline was 357 days with donepezil, compared with 208 days in the placebo group. Clinically evident functional decline was defined as loss of the ability to perform at least one basic self-care activity of daily living--bathing, feeding, dressing, walking--that was present at baseline, or a decline in the ability to perform 20% of higher-order activities of daily living that were present at baseline. These complex activities of daily living included housekeeping, shopping; managing money and hobbies and leisure activities, Dr. Ieni said.

At the 1-year mark, patients on donepezil had a statistically significant advantage in the ability to perform five of the higher-order activities of daily living: use of the telephone, handling personal mail, handling money, household tasks, and grasp of situations or explanations.

The risk of clinically evident functional decline in patients on donepezil was 62% of that in placebo-treated patients over 1 year. The probability of remaining in the study with no clinically evident functional decline at 48 weeks was 51% with donepezil and 35% with placebo.

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