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Clinical Pharmacology
CLINICAL PHARMACOLOGY
Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer’s Disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. If this proposed mechanism of action is correct, donepezil’s effect may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. There is no evidence that donepezil alters the course of the underlying dementing process. Text Continues Below
Clinical Trial Data The effectiveness of ARICEPT® as a treatment for Alzheimer’s Disease is demonstrated by the results of two randomized, double-blind, placebo-controlled clinical investigations in patients with Alzheimer’s Disease (diagnosed by NINCDS and DSM III-R criteria, Mini-Mental State Examination = 10 and = 26 and Clinical Dementia Rating of 1 or 2). The mean age of patients participating in ARICEPT® trials was 73 years with a range of 50 to 94. Approximately 62% of patients were women and 38% were men. The racial distribution was white 95%, black 3% and other races 2%. Study Outcome Measures: In each study, the effectiveness of treatment with ARICEPT® was evaluated using a dual outcome assessment strategy. The ability of ARICEPT® to improve cognitive performance was assessed with the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-cog), a multi-item instrument that has been extensively validated in longitudinal cohorts of Alzheimer’s Disease patients. The ADAS-cog examines selected aspects of cognitive performance including elements of memory, orientation, attention, reasoning, language and praxis. The ADAS-cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher. Page: 1 | 2 | 3 | 4 | 5 | Next >>
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