Therapeutic development paths for cognitive impairment in Parkinson's disease: report of a regulatory roundtable.
Identifieur interne : 000622 ( PubMed/Checkpoint ); précédent : 000621; suivant : 000623Therapeutic 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 [États-Unis] ; Daniel Weintraub [États-Unis] ; Jaime Kulisevsky [Espagne] ; Connie Marras [Canada] ; Glenn Stebbins [États-Unis] ; Karl Kieburtz [États-Unis]Source :
- Journal of Parkinson's disease [ 1877-718X ] ; 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.
DOI: 10.3233/JPD-140385
PubMed: 24989876
Affiliations:
- Canada, Espagne, États-Unis
- Catalogne, Illinois, Ontario, Pennsylvanie, État de New York
- Barcelone, Toronto
- Université de Toronto
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:24989876Le document en format XML
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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></affiliation></author></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></biblStruct></sourceDesc></fileDesc><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></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24989876</PMID><DateCreated><Year>2014</Year><Month>12</Month><Day>03</Day></DateCreated><DateCompleted><Year>2015</Year><Month>08</Month><Day>19</Day></DateCompleted><DateRevised><Year>2016</Year><Month>12</Month><Day>15</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1877-718X</ISSN><JournalIssue CitedMedium="Internet"><Volume>4</Volume><Issue>4</Issue><PubDate><Year>2014</Year></PubDate></JournalIssue><Title>Journal of Parkinson's disease</Title><ISOAbbreviation>J Parkinsons Dis</ISOAbbreviation></Journal><ArticleTitle>Therapeutic development paths for cognitive impairment in Parkinson's disease: report of a regulatory roundtable.</ArticleTitle><Pagination><MedlinePgn>585-9</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.3233/JPD-140385</ELocationID><Abstract><AbstractText>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.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Eberling</LastName><ForeName>Jamie</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Vincent</LastName><ForeName>Lona</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Michael J. Fox Foundation for Parkinson's Research, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goldman</LastName><ForeName>Jennifer G</ForeName><Initials>JG</Initials><AffiliationInfo><Affiliation>Rush University Medical Center, Chicago, IL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weintraub</LastName><ForeName>Daniel</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>University of Pennsylvania, Philadelphia, PA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kulisevsky</LastName><ForeName>Jaime</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Sant Pau Hospital, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marras</LastName><ForeName>Connie</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>University of Toronto, Toronto, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stebbins</LastName><ForeName>Glenn</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Rush University Medical Center, Chicago, IL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kieburtz</LastName><ForeName>Karl</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>University of Rochester, Rochester, NY, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>P50 NS053488</GrantID><Acronym>NS</Acronym><Agency>NINDS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>Netherlands</Country><MedlineTA>J Parkinsons Dis</MedlineTA><NlmUniqueID>101567362</NlmUniqueID><ISSNLinking>1877-7171</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2007 Sep 15;22(12):1689-707; quiz 1837</RefSource><PMID Version="1">17542011</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2014 Apr 15;29(5):622-33</RefSource><PMID Version="1">24757111</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2008 May 15;23(7):998-1005</RefSource><PMID Version="1">18381647</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>N Engl J Med. 2009 Sep 24;361(13):1268-78</RefSource><PMID Version="1">19776408</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arch Neurol. 1999 Mar;56(3):303-8</RefSource><PMID Version="1">10190820</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Am J 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Version="1">19933974</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Arch Neurol. 2010 Jan;67(1):64-70</RefSource><PMID Version="1">20065131</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2010 Jul 15;25(9):1170-6</RefSource><PMID Version="1">20310053</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Neurology. 2010 Nov 9;75(19):1717-25</RefSource><PMID Version="1">21060094</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2012 Mar;27(3):349-56</RefSource><PMID Version="1">22275317</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Geriatr Psychiatry Neurol. 2012 Jun;25(2):100-6</RefSource><PMID Version="1">22689702</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>JAMA Neurol. 2013 May;70(5):580-6</RefSource><PMID Version="1">23529397</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Neurology. 2013 Jul 23;81(4):346-52</RefSource><PMID Version="1">23794682</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Parkinsonism Relat Disord. 2013 Sep;19(9):812-7</RefSource><PMID Version="1">23773412</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2013 Jul;28(8):1034-49</RefSource><PMID Version="1">23426759</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2013 Jul;28(8):1097-103</RefSource><PMID Version="1">23630134</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>J Neurol Neurosurg Psychiatry. 2013 Nov;84(11):1258-64</RefSource><PMID Version="1">23781007</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2014 Apr 15;29(5):584-96</RefSource><PMID Version="1">24757108</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Mov Disord. 2014 Apr 15;29(5):608-21</RefSource><PMID Version="1">24757110</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Parkinsonism Relat Disord. 2008;14(2):93-101</RefSource><PMID Version="1">17707678</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="Y">Clinical Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003072" MajorTopicYN="N">Cognition Disorders</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000209" MajorTopicYN="Y">etiology</QualifierName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018450" MajorTopicYN="N">Disease Progression</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009483" MajorTopicYN="N">Neuropsychological 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