Donepezil in Parkinson's disease dementia: A randomized, double‐blind efficacy and safety study
Identifieur interne : 001293 ( Main/Exploration ); précédent : 001292; suivant : 001294Donepezil in Parkinson's disease dementia: A randomized, double‐blind efficacy and safety study
Auteurs : Bruno Dubois [France] ; Eduardo Tolosa [Espagne] ; Regina Katzenschlager [Autriche] ; Murat Emre [Turquie] ; Andrew J. Lees [Royaume-Uni] ; Günther Schumann [Allemagne] ; Emmanuelle Pourcher [Canada] ; Julian Gray [Suisse] ; Gail Thomas [Royaume-Uni] ; Jina Swartz [Royaume-Uni] ; Timothy Hsu [États-Unis] ; Margaret L. Moline [États-Unis]Source :
- Movement Disorders [ 0885-3185 ] ; 2012-09-01.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Analysis of Variance, Cholinesterase, Cholinesterase Inhibitors (therapeutic use), Cognition, Dementia, Dementia (complications), Dementia (drug therapy), Donepezil, Dose-Response Relationship, Drug, Double blind study, Double-Blind Method, Europe, Executive function, Female, Humans, Indans (therapeutic use), Male, Middle Aged, Nervous system diseases, Parkinson Disease (complications), Parkinson Disease (drug therapy), Parkinson disease, Piperidines (therapeutic use), Psychiatric Status Rating Scales, Safety, cholinesterase inhibition, cognition, dementia, executive function.
- MESH :
- chemical , therapeutic use : Cholinesterase Inhibitors, Indans, Piperidines.
- geographic : Europe.
- complications : Dementia, Parkinson Disease.
- drug therapy : Dementia, Parkinson Disease.
- Adult, Aged, Aged, 80 and over, Analysis of Variance, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales.
Abstract
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
Url:
DOI: 10.1002/mds.25098
Affiliations:
- Allemagne, Autriche, Canada, Espagne, France, Royaume-Uni, Suisse, Turquie, États-Unis
- Angleterre, Catalogne, Grand Londres, New Jersey, Vienne (Autriche), Île-de-France
- Barcelone, Londres, Paris, Vienne (Autriche)
- Université Pierre-et-Marie-Curie, Université de Barcelone
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Le document en format XML
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<term>Analysis of Variance</term>
<term>Cholinesterase</term>
<term>Cholinesterase Inhibitors (therapeutic use)</term>
<term>Cognition</term>
<term>Dementia</term>
<term>Dementia (complications)</term>
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<term>Parkinson Disease (drug therapy)</term>
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<term>Piperidines (therapeutic use)</term>
<term>Psychiatric Status Rating Scales</term>
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<front><div type="abstract" xml:lang="en">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</div>
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