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Donepezil

Donepezil, marketed under the trade name Aricept® (Eisai), is a centrally acting reversible acetyl cholinesterase inhibitor. Its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. It is well absorbed in the gut with an oral bioavailability of 100% and easily crosses the blood-brain barrier. Because it has a half life of about 70 hours, it can be taken once a day. Initial dose is 5 mg per day, which can be increased to 10 mg per day after an adjustment period of at least 4 weeks. more...

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The clinical utility of donepezil is controversial. Presently, there is no proof that use of donepezil or other similar agents alters the course or progression of Alzheimer's disease. However, controlled studies have shown modest benefits in cognition and behavior with this and similar agents. Therefore, many neurologists, psychiatrists, and primary care physicians use donepezil in patients with Alzheimer's disease. As of the 22 March 2005, the UK National Institute for Clinical Excellence (NICE) withdrew its recommendation for use of the drug for mild-to-moderate AD, on the basis that there is no significant improvement in functional outcome; of quality of life or of behavioral symptoms. However, these data conflict with those of other reports, as is often the case in medicine.

Donepezil is sometimes used in combination with Memantine, a new agent for Alzheimer's disease which is in the same chemical class. The response to both together is superior to either alone.

Donepezil has been tested in other disorders which cause dementia including Lewy body dementia and Vascular dementia, but it is not currently approved for these indications.

Sources

Brenner, G. M. (2000). Pharmacology. Philadelphia, PA: W.B. Saunders Company. ISBN 0-7216-7757-6
Canadian Pharmacists Association (2000). Compendium of Pharmaceuticals and Specialties (25th ed.). Toronto, ON: Webcom. ISBN 0-919115-76-4

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Donepezil shows short-term benefit in slowing MCI progression to AD; vitamin E use has little advantage
From Geriatrics, 10/1/04

Donepezil therapy, compared to placebo, may reduce the rate of progression to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI), according to Ronald Petersen, MD, PhD, of the Mayo Clinic in Rochester, Minn., who presented data at the Alzheimer's conference. The study found no apparent benefit from use of vitamin E.

Although researchers found an AD risk reduction with donepezil therapy, the effect appears to be short in duration, lasting for the first 18 months of a 3-year trial. Of individuals in the study who progressed to Alzheimer's, donepezil therapy delayed onset for an average of 6 months longer than those taking placebo.Researchers found a subtle, statistically insignificant effect on cognitive improvement and language in subjects who took vitamin E.

"This is the first study to demonstrate a positive treatment effect on progression to Alzheimer's disease from MCI," said Dr. Petersen, principal investigator in the study funded by the National Institute on Aging, Pfizer, Eisai, and DSM Nutritional Products. "It looks like the drug had a modest, time-limited effect. Nonetheless, we are optimistic because we have begun to make progress toward delaying the development of Alzheimer's."

The Alzheimer's Disease Cooperative Study was a randomized, double-blind, placebo-controlled trial. Researchers examined 769 people with MCI (average age 72, 54% male) in the United States and Canada who had been assigned to treatment arms of donepezil, 10 mg/d, vitamin E, 2,000 IU/d, or placebo. All subjects received a multivitamin.

In 3 years, MCI progression to AD was 13% annually, compared with about 1 to 2 percent per year in people of similar age without MCI. A total of 193 subjects converted to possible or probable AD and 2 to other dementias. Apolipoprotein (Apo) E4 carrier status was a strong predictor of conversion in the combined groups. The implications of the Apo E4 finding are still under discussion, according to Dr. Petersen, who was unable to comment on its clinical significance.

Researchers concluded that further investigation is needed before making clinical recommendations about whether to prescribe donepezil in the early stages of cognitive impairment.

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