MovDisordV3, Main, Exploration, bibRecord, 001143

Donepezil in Parkinson's Disease Dementia: A Randomized, Double-Blind Efficacy and Safety Study

Identifieur interne : 001143 ( Main/Exploration ); précédent : 001142; suivant : 001144

Donepezil 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 Lees (neurologue) [Royaume-Uni] ; Gunther 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.

RBID : Pascal:12-0369631

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Démence, Pathologie du système nerveux, Donépézil, Etude double insu, Sécurité, Cognition, Fonction exécutive, Cholinesterase.

English descriptors

KwdEn :
- Cholinesterase, Cognition, Dementia, Donepezil, Double blind study, Executive function, Nervous system diseases, Parkinson disease, Safety.

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.

Affiliations:

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cholinesterase</term>
<term>Cognition</term>
<term>Dementia</term>
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<term>Executive function</term>
<term>Nervous system diseases</term>
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<term>Safety</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term>
<term>Démence</term>
<term>Pathologie du   système nerveux</term>
<term>Donépézil</term>
<term>Etude double insu</term>
<term>Sécurité</term>
<term>Cognition</term>
<term>Fonction exécutive</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.</div>
</front>
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   |texte=   Donepezil in Parkinson's Disease Dementia: A Randomized, Double-Blind Efficacy and Safety Study
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	Movement Disorders (revue)
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

Movement Disorders (revue)

Donepezil in Parkinson's Disease Dementia: A Randomized, Double-Blind Efficacy and Safety Study

Donepezil in Parkinson's Disease Dementia: A Randomized, Double-Blind Efficacy and Safety Study

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