Aricept ineffective for agitation of Alzheimer's

By Anthony J. Brown, MD

NEW YORK (Reuters Health) - Donepezil (Aricept), a drug used to help preserve brain function in patients with Alzheimer's disease, does little it seems to help control the agitation often seen in patients with Alzheimer's disease, according to a report in this week's New England Journal of Medicine.

Donepezil and other so-called "cholinesterase inhibitors" were developed to improve thinking, memory and concentration in patients Alzheimer's disease. "Some studies, primarily of cognitive change, also included behavior changes as a secondary outcome and reported positive changes," Dr. Robert J. Howard, the lead author of the new study, told Reuters Health.

"We were first to use one of these drugs to treat patients with Alzheimer's disease whose main problem is disturbed and agitated behavior," he added.

The new study by Howard and colleagues involved 272 patients with significant Alzheimer's disease-related agitation, refractory to a brief psychosocial treatment, who were randomized to receive donepezil (10 mg daily) or placebo for 12 weeks.

Results showed that donepezil was no better than inactive placebo in reducing agitation. Roughly 20 percent of patients in each group experienced a 30 percent or greater improvement in their level of agitation.

Regarding the main study finding, Howard, from King's College London, said "we were surprised and disappointed." Donepezil "didn't work at all."

"Although many doctors believe that (cholinesterase inhibitors) improve behavior disturbance in Alzheimer's disease and the companies that manufacture the drugs mention this potential effect in their advertising, we have to keep on looking for a treatment," Howard said.

SOURCE: The New England Journal of Medicine, October 4, 2007.