Objective: To evaluate the efficacy and safety of Donepezil, an acetylcholinesterase inhibitor, as a treatment for cognitive impairment and dementia in patients with Parkinson’s disease (PD).
Design: The study was a randomized, double-blind, placebo-controlled trial.
Materials and Methods: Nine patients received placebo and 7 patients received Donepezil (2.5-10 mg/day) for a mean (SD) of 15.2(3.4) weeks. The primary efficacy outcome measures were derived from a neuropsychological battery that assessed global cognitive status as well as memory, attention, psychomotor speed, and visuospatial and exectuve functions. Secondary efficacy outcomes included psychiatric symptom ratings. Primary safety measures were motor status and activities of daily living and assessments of adverse effects.
Results: Patients on Donepezil showed selective and significant (p<.05)improvement on the memory subscale of the Mattis Dementia Rating Scale. There was also a pattern of selective improvement on a measure of psychomotor speed and attention. There were no group differences in psychiatric status, motor function, or activities of daily living as measured at baseline and end-point between the two groups. Adverse effects resulted in premature withdrawal of four patients on Donepezil, including two with peripheral cholinergic effects and one with increased parkinsonism. Side effects were associated with dosage increases.
Conclusion: Donepezil has a beneficial effect on memory, and may improve other cognitive deficits in patients with PD and cognitive impairment. However, variable tolerability in our sample underscores the need for careful monitoring when prescribing Donepezil in patients with PD, especially with dosage increases.
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