Therapeutic Development Paths for Cognitive Impairment in Parkinson's Disease: Report of a Regulatory Roundtable
Identifieur interne : 001813 ( Ncbi/Merge ); précédent : 001812; suivant : 001814Therapeutic Development Paths for Cognitive Impairment in Parkinson's Disease: Report of a Regulatory Roundtable
Auteurs : Jamie Eberling [États-Unis] ; Lona Vincent [États-Unis] ; Jennifer G. Goldman ; Daniel Weintraub ; Jaime Kulisevsky ; Connie Marras ; Glenn Stebbins ; Karl KieburtzSource :
- Journal of Parkinson's disease [ 1877-7171 ] ; 2014.
English descriptors
- KwdEn :
- MESH :
- complications : Parkinson Disease.
- diagnosis : Cognition Disorders.
- etiology : Cognition Disorders.
- psychology : Parkinson Disease.
- therapy : Cognition Disorders.
- Clinical Trials as Topic, Disease Progression, Humans, Neuropsychological Tests, Quality of Life.
Abstract
Cognitive impairment is a common occurrence in Parkinson's disease (PD), although the severity and specific presentation varies across patients. Initial deficits, including mild cognitive impairment (PD-MCI), may remain stable or in many cases, may progress over variable lengths of time to Parkinson's disease dementia (PDD). As there are currently no marketed treatments for milder forms of cognitive impairment, an opportunity exists to define the path for therapeutic development in this area. In the absence of a well-defined path for the approval of therapies that target PD-MCI, pharmaceutical companies are unlikely to pursue this indication. In order to move forward and improve the quality of life for PD patients, it is imperative for the field to have consensus on the definition of PD-MCI, the best instruments to measure cognitive decline, and a strategy for future clinical trials.
Url:
DOI: 10.3233/JPD-140385
PubMed: 24989876
PubMed Central: 4371591
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PMC:4371591Le document en format XML
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<front><div type="abstract" xml:lang="en"><p id="P1">Cognitive impairment is a common occurrence in Parkinson's disease (PD), although the severity and specific presentation varies across patients. Initial deficits, including mild cognitive impairment (PD-MCI), may remain stable or in many cases, may progress over variable lengths of time to Parkinson's disease dementia (PDD). As there are currently no marketed treatments for milder forms of cognitive impairment, an opportunity exists to define the path for therapeutic development in this area. In the absence of a well-defined path for the approval of therapies that target PD-MCI, pharmaceutical companies are unlikely to pursue this indication. In order to move forward and improve the quality of life for PD patients, it is imperative for the field to have consensus on the definition of PD-MCI, the best instruments to measure cognitive decline, and a strategy for future clinical trials.</p>
</div>
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<front><div type="abstract" xml:lang="en"><p id="P1">Cognitive impairment is a common occurrence in Parkinson's disease (PD), although the severity and specific presentation varies across patients. Initial deficits, including mild cognitive impairment (PD-MCI), may remain stable or in many cases, may progress over variable lengths of time to Parkinson's disease dementia (PDD). As there are currently no marketed treatments for milder forms of cognitive impairment, an opportunity exists to define the path for therapeutic development in this area. In the absence of a well-defined path for the approval of therapies that target PD-MCI, pharmaceutical companies are unlikely to pursue this indication. In order to move forward and improve the quality of life for PD patients, it is imperative for the field to have consensus on the definition of PD-MCI, the best instruments to measure cognitive decline, and a strategy for future clinical trials.</p>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Therapeutic development paths for cognitive impairment in Parkinson's disease: report of a regulatory roundtable.</title>
<author><name sortKey="Eberling, Jamie" sort="Eberling, Jamie" uniqKey="Eberling J" first="Jamie" last="Eberling">Jamie Eberling</name>
<affiliation wicri:level="2"><nlm:affiliation>Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Michael J. Fox Foundation for Parkinson's Research, New York, NY</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Vincent, Lona" sort="Vincent, Lona" uniqKey="Vincent L" first="Lona" last="Vincent">Lona Vincent</name>
<affiliation wicri:level="2"><nlm:affiliation>Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Michael J. Fox Foundation for Parkinson's Research, New York, NY</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Goldman, Jennifer G" sort="Goldman, Jennifer G" uniqKey="Goldman J" first="Jennifer G" last="Goldman">Jennifer G. Goldman</name>
<affiliation wicri:level="2"><nlm:affiliation>Rush University Medical Center, Chicago, IL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Rush University Medical Center, Chicago, IL</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Weintraub, Daniel" sort="Weintraub, Daniel" uniqKey="Weintraub D" first="Daniel" last="Weintraub">Daniel Weintraub</name>
<affiliation wicri:level="2"><nlm:affiliation>University of Pennsylvania, Philadelphia, PA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Pennsylvania, Philadelphia, PA</wicri:regionArea>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kulisevsky, Jaime" sort="Kulisevsky, Jaime" uniqKey="Kulisevsky J" first="Jaime" last="Kulisevsky">Jaime Kulisevsky</name>
<affiliation wicri:level="3"><nlm:affiliation>Sant Pau Hospital, Barcelona, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Sant Pau Hospital, Barcelona</wicri:regionArea>
<placeName><settlement type="city">Barcelone</settlement>
<region nuts="2" type="region">Catalogne</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Marras, Connie" sort="Marras, Connie" uniqKey="Marras C" first="Connie" last="Marras">Connie Marras</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Toronto, Toronto, Canada.</nlm:affiliation>
<country xml:lang="fr">Canada</country>
<wicri:regionArea>University of Toronto, Toronto</wicri:regionArea>
<orgName type="university">Université de Toronto</orgName>
<placeName><settlement type="city">Toronto</settlement>
<region type="state">Ontario</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Stebbins, Glenn" sort="Stebbins, Glenn" uniqKey="Stebbins G" first="Glenn" last="Stebbins">Glenn Stebbins</name>
<affiliation wicri:level="2"><nlm:affiliation>Rush University Medical Center, Chicago, IL, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Rush University Medical Center, Chicago, IL</wicri:regionArea>
<placeName><region type="state">Illinois</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name>
<affiliation wicri:level="2"><nlm:affiliation>University of Rochester, Rochester, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>University of Rochester, Rochester, NY</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
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</analytic>
<series><title level="j">Journal of Parkinson's disease</title>
<idno type="eISSN">1877-718X</idno>
<imprint><date when="2014" type="published">2014</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical Trials as Topic</term>
<term>Cognition Disorders (diagnosis)</term>
<term>Cognition Disorders (etiology)</term>
<term>Cognition Disorders (therapy)</term>
<term>Disease Progression</term>
<term>Humans</term>
<term>Neuropsychological Tests</term>
<term>Parkinson Disease (complications)</term>
<term>Parkinson Disease (psychology)</term>
<term>Quality of Life</term>
</keywords>
<keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Cognition Disorders</term>
</keywords>
<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Cognition Disorders</term>
</keywords>
<keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Cognition Disorders</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Clinical Trials as Topic</term>
<term>Disease Progression</term>
<term>Humans</term>
<term>Neuropsychological Tests</term>
<term>Quality of Life</term>
</keywords>
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<front><div type="abstract" xml:lang="en">Cognitive impairment is a common occurrence in Parkinson's disease (PD), although the severity and specific presentation varies across patients. Initial deficits, including mild cognitive impairment (PD-MCI), may remain stable or in many cases, may progress over variable lengths of time to Parkinson's disease dementia (PDD). As there are currently no marketed treatments for milder forms of cognitive impairment, an opportunity exists to define the path for therapeutic development in this area. In the absence of a well-defined path for the approval of therapies that target PD-MCI, pharmaceutical companies are unlikely to pursue this indication. In order to move forward and improve the quality of life for PD patients, it is imperative for the field to have consensus on the definition of PD-MCI, the best instruments to measure cognitive decline, and a strategy for future clinical trials.</div>
</front>
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