MovDisordV3, PascalFrancis, Checkpoint, bibRecord, 000216

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

Identifieur interne : 000216 ( PascalFrancis/Checkpoint ); précédent : 000215; suivant : 000217

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:

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Donepezil in Parkinson's Disease Dementia: A Randomized, Double-Blind Efficacy and Safety Study</title>
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<author><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Neurology Service, Centro de Investigación Biomédica en Red sobre Enfermedades Neurodegenerativas (CIBERNED), Hospital Clinic, IDIBAPS, Universitat de Barcelona</s1>
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<author><name sortKey="Pourcher, Emmanuelle" sort="Pourcher, Emmanuelle" uniqKey="Pourcher E" first="Emmanuelle" last="Pourcher">Emmanuelle Pourcher</name>
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<author><name sortKey="Swartz, Jina" sort="Swartz, Jina" uniqKey="Swartz J" first="Jina" last="Swartz">Jina Swartz</name>
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<s3>GBR</s3>
<sZ>9 aut.</sZ>
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<author><name sortKey="Hsu, Timothy" sort="Hsu, Timothy" uniqKey="Hsu T" first="Timothy" last="Hsu">Timothy Hsu</name>
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<s2>New Jersey</s2>
<s3>USA</s3>
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</placeName>
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<author><name sortKey="Moline, Margaret L" sort="Moline, Margaret L" uniqKey="Moline M" first="Margaret L." last="Moline">Margaret L. Moline</name>
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<series><title level="j" type="main">Movement disorders</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Cholinesterase</term>
<term>Cognition</term>
<term>Dementia</term>
<term>Donepezil</term>
<term>Double blind study</term>
<term>Executive function</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Safety</term>
</keywords>
<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>
<term>Cholinesterase</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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<sZ>1 aut.</sZ>
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<s3>ESP</s3>
<sZ>2 aut.</sZ>
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<fA14 i1="03"><s1>Department of Neurology, Donauspital/SMZ-Ost</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Istanbul University, Department of Neurology, Behavioral Neurology and Movement Disorders Unit</s1>
<s2>Istanbul</s2>
<s3>TUR</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Reta Lila Weston Institute of Neurological Studies and the National Hospital for Neurology and Neurosurgery, Queen Square</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>5 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>Castroper Hellweg 422 44805</s1>
<s2>Bochum</s2>
<s3>DEU</s3>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Quebec Memory and Motor Skills Disorders Research Center, Clinique Sainte Anne</s1>
<s2>Quebec</s2>
<s3>CAN</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="08"><s1>McArthur and Associates GmbH</s1>
<s2>Basel</s2>
<s3>CHE</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Eisai Limited</s1>
<s2>Hatfield</s2>
<s3>GBR</s3>
<sZ>9 aut.</sZ>
<sZ>10 aut.</sZ>
</fA14>
<fA14 i1="10"><s1>Eisai Inc., Woodcliff Lake</s1>
<s2>New Jersey</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
<sZ>12 aut.</sZ>
</fA14>
<fA20><s1>1230-1238</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>20953</s2>
<s5>354000502011860090</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>31 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>12-0369631</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Movement disorders</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>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.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B17G</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Maladie de Parkinson</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Démence</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Dementia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Demencia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Pathologie du   système nerveux</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>03</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>03</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Donépézil</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Donepezil</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Donepezilo</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Etude double insu</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Double blind study</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Estudio doble ciego</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Sécurité</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Safety</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Seguridad</s0>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Cognition</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Cognition</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Cognición</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Fonction exécutive</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Executive function</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Función ejecutiva</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE"><s0>Cholinesterase</s0>
<s2>FE</s2>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG"><s0>Cholinesterase</s0>
<s2>FE</s2>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA"><s0>Cholinesterase</s0>
<s2>FE</s2>
<s5>14</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Carboxylic ester hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Carboxylic ester hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Carboxylic ester hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Esterases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Esterases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Esterases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Hydrolases</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Enzyme</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Enzima</s0>
<s2>FE</s2>
</fC07>
<fC07 i1="05" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>37</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Syndrome extrapyramidal</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="07" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="07" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>39</s5>
</fC07>
<fC07 i1="08" i2="X" l="FRE"><s0>Pathologie du   système nerveux central</s0>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="08" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>40</s5>
</fC07>
<fN21><s1>289</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations><list><country><li>Allemagne</li>
<li>Autriche</li>
<li>Canada</li>
<li>Espagne</li>
<li>France</li>
<li>Royaume-Uni</li>
<li>Suisse</li>
<li>Turquie</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Catalogne</li>
<li>Grand Londres</li>
<li>New Jersey</li>
<li>Vienne (Autriche)</li>
</region>
<settlement><li>Barcelone</li>
<li>Londres</li>
<li>Paris</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName><li>National Hospital for Neurology and Neurosurgery</li>
</orgName>
</list>
<tree><country name="France"><noRegion><name sortKey="Dubois, Bruno" sort="Dubois, Bruno" uniqKey="Dubois B" first="Bruno" last="Dubois">Bruno Dubois</name>
</noRegion>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Tolosa, Eduardo" sort="Tolosa, Eduardo" uniqKey="Tolosa E" first="Eduardo" last="Tolosa">Eduardo Tolosa</name>
</region>
</country>
<country name="Autriche"><region name="Vienne (Autriche)"><name sortKey="Katzenschlager, Regina" sort="Katzenschlager, Regina" uniqKey="Katzenschlager R" first="Regina" last="Katzenschlager">Regina Katzenschlager</name>
</region>
</country>
<country name="Turquie"><noRegion><name sortKey="Emre, Murat" sort="Emre, Murat" uniqKey="Emre M" first="Murat" last="Emre">Murat Emre</name>
</noRegion>
</country>
<country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Lees, Andrew J" sort="Lees, Andrew J" uniqKey="Lees A" first="Andrew J." last="Lees">Andrew Lees (neurologue)</name>
</region>
<name sortKey="Swartz, Jina" sort="Swartz, Jina" uniqKey="Swartz J" first="Jina" last="Swartz">Jina Swartz</name>
<name sortKey="Thomas, Gail" sort="Thomas, Gail" uniqKey="Thomas G" first="Gail" last="Thomas">Gail Thomas</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="Schumann, Gunther" sort="Schumann, Gunther" uniqKey="Schumann G" first="Gunther" last="Schumann">Gunther Schumann</name>
</noRegion>
</country>
<country name="Canada"><noRegion><name sortKey="Pourcher, Emmanuelle" sort="Pourcher, Emmanuelle" uniqKey="Pourcher E" first="Emmanuelle" last="Pourcher">Emmanuelle Pourcher</name>
</noRegion>
</country>
<country name="Suisse"><noRegion><name sortKey="Gray, Julian" sort="Gray, Julian" uniqKey="Gray J" first="Julian" last="Gray">Julian Gray</name>
</noRegion>
</country>
<country name="États-Unis"><region name="New Jersey"><name sortKey="Hsu, Timothy" sort="Hsu, Timothy" uniqKey="Hsu T" first="Timothy" last="Hsu">Timothy Hsu</name>
</region>
<name sortKey="Moline, Margaret L" sort="Moline, Margaret L" uniqKey="Moline M" first="Margaret L." last="Moline">Margaret L. Moline</name>
</country>
</tree>
</affiliations>
</record>

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	Movement Disorders (revue)
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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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