DOCTOR'S VIEW ARCHIVE
The following is provided from an FDA information release regarding a newly approved drug (1996) for Alzheimer's disease, a progressive brain disorder. The drug, called Aricept (donepezil), has received approval for use for mild to moderate symptoms of Alzheimer's disease.
Alzheimer's disease, which affects an estimated four million Americans, is a progressive condition affecting memory, judgment, and the ability to reason. Aricept is a cholinesterase inhibitor that increases levels of acetylcholine, a chemical messenger in the brain (neurotransmitter) which is important for normal thinking. Although the drug has not been shown to have an effect on the underlying cause of Alzheimer's disease, it may diminish some of the disease symptoms.
In a 30-week study of 473 patients, patients on Aricept improved on two assessment scales compared to those on a placebo. A second 15- week study confirmed these results. The ability of Aricept to modify the ability to think clearly (cognitive performance) was assessed with the Alzheimer's Disease Assessment Scale -- cognitive subscale score (ADAS Cog), a measurement including a specific performance test that assesses memory, attention, language and reasoning abilities. A physician's interview-based assessment provided clinical confirmation of the benefit associated with treatment.
The two clinical trials showed that the majority of patients can tolerate the typical side effects such as diarrhea and nausea. The labeling also warns that the drug has the potential to cause bradycardia (slow heart rate), especially in patients with underlying abnormalities of the heart's electrical system. Syncope (fainting spells) has been reported in some patients.
FDA approved Aricept, the first for the drug worldwide, in less than 7.5 months. Aricept is only the second drug approved to treat the symptoms of this disease; Tacrine (cognex), manufactured by Warner Lambert was approved in l993). Aricept will be marketed by Eisai America Inc. of Teaneck, NJ and Pfizer of New York, NY.