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Donepezil in Parkinson’s disease dementia: a randomized, double-blind efficacy and safety study


Dubois, Bruno, Tolosa, Eduardo, Katzenschlager, Regina, Emre, Murat, Lees, Andrew J., Schumann, Günther, Pourcher, Emmanuelle, Gray, Julian, Thomas, Gail, Swartz, Jina, Hsu, Timothy, Moline, Margaret L.


Movement Disorders: Official Journal Of The Movement Disorder Society, Volume: 27, No.: 10, Pages.: 1230-1238

Year of Publication



Parkinson’s disease dementia (PDD) is associated with cholinergic deficits. This report presents an efficacy and safety study of the acetylcholinesterase inhibitor donepezil hydrochloride in PDD. PDD patients (n = 550) were randomized to donepezil (5 or 10 mg) or placebo for 24 weeks. Coprimary end points were the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) and Clinician’s Interview-Based Impression of Change plus caregiver input (CIBIC+; global function). Secondary end points measured executive function, attention, activities of daily living (ADLs), and behavioral symptoms. Safety and tolerability were assessed. ADAS-cog mean changes from baseline to week 24 (end point) were not significant for donepezil in the intent-to-treat population by the predefined statistical model (difference from placebo: -1.45, P = .050, for 5 mg; -1.45, P = .076, for 10 mg). Alternative ADAS-cog analysis, removing the treatment-by-country interaction term from the model, revealed significant, dose-dependent benefit with donepezil (difference from placebo: -2.08, P = .002, for 5 mg; -3.31, P < .001, for 10 mg). The 10-mg group, but not the 5-mg group, had significantly better CIBIC+ scores compared with placebo (3.7 vs 3.9, P = .113, for 5 mg; 3.6 vs 3.9, P = .040, for 10 mg). Secondary end points-Mini-Mental State Exam; Delis-Kaplan Executive Function System; Brief Test of Attention, representing cognitive functions particularly relevant to PDD-showed significant benefit for both donepezil doses (P ≤ .007). There were no significant differences in ADLs or behavior. Adverse events were more common with donepezil but mostly mild/moderate in severity. Although the study did not achieve its predefined primary end points, it presents evidence suggesting that donepezil can improve cognition, executive function, and global status in PDD. Tolerability was consistent with the known safety profile of donepezil. © 2012 Movement Disorder Society.; Copyright © 2012 Movement Disorder Society.

Bibtex Citation

@article{Dubois_2012, doi = {10.1002/mds.25098}, url = {}, year = 2012, month = {aug}, publisher = {Wiley-Blackwell}, volume = {27}, number = {10}, pages = {1230--1238}, author = {Bruno Dubois and Eduardo Tolosa and Regina Katzenschlager and Murat Emre and Andrew J. Lees and Günther Schumann and Emmanuelle Pourcher and Julian Gray and Gail Thomas and Jina Swartz and Timothy Hsu and Margaret L. Moline}, title = {Donepezil in Parkinson{textquotesingle}s disease dementia: A randomized, double-blind efficacy and safety study}, journal = {Mov. Disord.} }


adult, aged, aged, 80 and over, analysis of variance, cholinesterase inhibitors, complications, dementia, donepezil, double-blind method, drug therapy, europe, female, humans, indans, male, middle aged, parkinson disease, piperidines, psychiatric status rating scales, therapeutic use

Countries of Study


Types of Dementia

Parkinson’s Dementia

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Behaviour, Cognition

Type of Interventions

Pharmaceutical Interventions

Risk Factor Modifications

At risk population

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime