An Open-label Clinical Trial Evaluating the Safety and Efficacy of Donepezil in Patients with Mild to Moderate Alzheimer's Disease
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Alzheimer's disease is a deficit in intellectual functioning characterized by a gradual onset of difficulty with memory, cognition, and activities of daily living. The Alzheimer's brain is identified by neuritic plaques and neurofibrillary tangles. According to the cholinergic hypothesis, memory deficits are also related to decreased cholinergic functioning. Acetylcholinesterase inhibitors, such as donepezil, work to increase acetylcholine levels by inhibiting the enzyme that breaks down this neurotransmitter in the synapse. In this study, donepezil was tested on seven subjects with Alzheimer's for both safety and efficacy over at least twelve weeks. Safety measures included vital signs, electrocardiograms, physical examinations, laboratory assessments, and adverse event tracking. Efficacy was tracked by the Mini Mental State Examination and the Physician's Evaluation Form. Donepezil proved to be a very safe medication in this subject pool. However, gastrointestinal side effects were present in three of the seven subjects. Generally, stablilzation was noted in scores on the Mini Mental State Examination and the cognition section of the Physician's Evaluation Form. Initial improvement was found in several subjects, but only during the first two to three months of treatment. No dramatic stabilization occurred in activities of daily living or behavior as measured by the Physician's Evaluation Form. Thus, donepezil is an effective medication to slow the cognitive decline of Alzheimer's disease. These results are consistent with the mechanism of acetylcholinesterase inhibitors, as they work to improve memory. Donepezil can best be used to treat Alzheimer's when used in combination with medications that improve other symptoms of the disease, such as anxiety or depression.