Randomized placebo-controlled trial of donepezil in cognitive impairment in Parkinson's disease
Version of Record online: 5 JAN 2004
Copyright © 2004 John Wiley & Sons, Ltd.
International Journal of Geriatric Psychiatry
Volume 19, Issue 1, pages 1–8, January 2004
How to Cite
Leroi, I., Brandt, J., Reich, S. G., Lyketsos, C. G., Grill, S., Thompson, R. and Marsh, L. (2004), Randomized placebo-controlled trial of donepezil in cognitive impairment in Parkinson's disease. Int. J. Geriat. Psychiatry, 19: 1–8. doi: 10.1002/gps.993
- Issue online: 5 JAN 2004
- Version of Record online: 5 JAN 2004
- Manuscript Accepted: 2 JUL 2003
- Manuscript Received: 3 MAR 2003
- Eisai/Pfizer Inc.
- Morris K. Udall Parkinson's Disease Research Center of Excellence at Johns Hopkins. Grant Number: NIH P50-NS-58377
- General Clinical Research Center at Johns Hopkins University School of Medicine
- National Center for Research Resources. Grant Number: NIH M01-RR00052
- Parkinson' s disease;
- cognitive impairment;
- cholinesterase inhibitors;
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).
Using a randomized, double-blind, placebo-controlled design, nine patients received placebo and seven patients received donepezil (2.5–10 mg/day) for a mean (SD) duration of 15.2 (3.4) weeks. The primary efficacy outcomes were derived from a neuropsychological battery that assessed global cognitive status as well as memory, attention, psychomotor speed, and visuospatial and executive functions. Secondary efficacy outcomes were psychiatric symptom and activities of daily living ratings. Primary safety measures were motor signs and assessments of adverse effects.
Patients on donepezil showed selective and significant (p<0.05) improvement on the memory subscale of the Dementia Rating Scale. There was also a trend toward 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 or end-point. Adverse effects resulted in premature withdrawal of four patients on donepezil, two for peripheral cholinergic effects and one for increased parkinsonism. Side effects were associated with dosage increases.
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 to patients with PD, especially with dosage increases. Copyright © 2004 John Wiley & Sons, Ltd.