A longitudinal program for biomarker development in Parkinson's disease: A feasibility study
Identifieur interne : 000628 ( Main/Corpus ); précédent : 000627; suivant : 000629A longitudinal program for biomarker development in Parkinson's disease: A feasibility study
Auteurs : Bernard Ravina ; Caroline Tanner ; Diane Dieuliis ; Shirley Eberly ; Emily Flagg ; Wendy R. Galpern ; Stanley Fahn ; Christopher G. Goetz ; Stephen Grate ; Roger Kurlan ; Anthony E. Lang ; Kenneth Marek ; Karl Kieburtz ; David Oakes ; Robin Elliott ; Ira ShoulsonSource :
- Movement Disorders [ 0885-3185 ] ; 2009-10-30.
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Abstract
Long‐term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS‐PD) is an observational study designed to prospectively measure the evolution of motor and non‐motor features of PD and sample promising biomarkers from early to late stage illness. LABS‐PD is organized on the premise that cohorts from completed clinical trials can be re‐recruited for long‐term follow up. LABS‐PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow‐up. A biomarker sub‐study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α‐synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS‐PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society
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DOI: 10.1002/mds.22690
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Galpern</name><affiliation><mods:affiliation>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Fahn, Stanley" sort="Fahn, Stanley" uniqKey="Fahn S" first="Stanley" last="Fahn">Stanley Fahn</name><affiliation><mods:affiliation>Department of Neurology, Columbia University, New York, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Goetz, Christopher G" sort="Goetz, Christopher G" uniqKey="Goetz C" first="Christopher G." last="Goetz">Christopher G. Goetz</name><affiliation><mods:affiliation>Department of Neurosciences, Rush University Medical Center, Chicago, Illinois, USA</mods:affiliation></affiliation></author><author><name sortKey="Grate, Stephen" sort="Grate, Stephen" uniqKey="Grate S" first="Stephen" last="Grate">Stephen Grate</name><affiliation><mods:affiliation>Telemedicine and Advanced Technology Research Center, Fort Detrick, Maryland, USA</mods:affiliation></affiliation></author><author><name sortKey="Kurlan, Roger" sort="Kurlan, Roger" uniqKey="Kurlan R" first="Roger" last="Kurlan">Roger Kurlan</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name><affiliation><mods:affiliation>Department of Medicine, Division of Neurology, Univerisity of Toronto, Toronto, Ontario, Canada</mods:affiliation></affiliation></author><author><name sortKey="Marek, Kenneth" sort="Marek, Kenneth" uniqKey="Marek K" first="Kenneth" last="Marek">Kenneth Marek</name><affiliation><mods:affiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</mods:affiliation></affiliation></author><author><name sortKey="Kieburtz, Karl" sort="Kieburtz, Karl" uniqKey="Kieburtz K" first="Karl" last="Kieburtz">Karl Kieburtz</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Oakes, David" sort="Oakes, David" uniqKey="Oakes D" first="David" last="Oakes">David Oakes</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Elliott, Robin" sort="Elliott, Robin" uniqKey="Elliott R" first="Robin" last="Elliott">Robin Elliott</name><affiliation><mods:affiliation>The Parkinson's Disease Foundation, New York, New York, USA</mods:affiliation></affiliation></author><author><name sortKey="Shoulson, Ira" sort="Shoulson, Ira" uniqKey="Shoulson I" first="Ira" last="Shoulson">Ira Shoulson</name><affiliation><mods:affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-10-30">2009-10-30</date><biblScope unit="volume">24</biblScope><biblScope unit="issue">14</biblScope><biblScope unit="page" from="2081">2081</biblScope><biblScope unit="page" to="2090">2090</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">C459F8C897606D94073150044749C8A83D0A7482</idno><idno type="DOI">10.1002/mds.22690</idno><idno type="ArticleID">MDS22690</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>biomarker</term><term>progression</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Long‐term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS‐PD) is an observational study designed to prospectively measure the evolution of motor and non‐motor features of PD and sample promising biomarkers from early to late stage illness. LABS‐PD is organized on the premise that cohorts from completed clinical trials can be re‐recruited for long‐term follow up. LABS‐PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow‐up. A biomarker sub‐study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α‐synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS‐PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Bernard Ravina MD, MSCE</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Caroline Tanner MD, PhD</name><affiliations><json:string>The Parkinson's Institute, Sunnyvale, California, USA</json:string></affiliations></json:item><json:item><name>Diane DiEuliis PhD</name><affiliations><json:string>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</json:string></affiliations></json:item><json:item><name>Shirley Eberly MS</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Emily Flagg BA</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Wendy R. Galpern MD, PhD</name><affiliations><json:string>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</json:string></affiliations></json:item><json:item><name>Stanley Fahn MD</name><affiliations><json:string>Department of Neurology, Columbia University, New York, New York, USA</json:string></affiliations></json:item><json:item><name>Christopher G. Goetz MD</name><affiliations><json:string>Department of Neurosciences, Rush University Medical Center, Chicago, Illinois, USA</json:string></affiliations></json:item><json:item><name>Stephen Grate DVM</name><affiliations><json:string>Telemedicine and Advanced Technology Research Center, Fort Detrick, Maryland, USA</json:string></affiliations></json:item><json:item><name>Roger Kurlan MD</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Anthony E. Lang MD</name><affiliations><json:string>Department of Medicine, Division of Neurology, Univerisity of Toronto, Toronto, Ontario, Canada</json:string></affiliations></json:item><json:item><name>Kenneth Marek MD</name><affiliations><json:string>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</json:string></affiliations></json:item><json:item><name>Karl Kieburtz MD, MPH</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>David Oakes PhD</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item><json:item><name>Robin Elliott MA</name><affiliations><json:string>The Parkinson's Disease Foundation, New York, New York, USA</json:string></affiliations></json:item><json:item><name>Ira Shoulson MD</name><affiliations><json:string>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Parkinson's disease</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>progression</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>biomarker</value></json:item></subject><articleId><json:string>MDS22690</json:string></articleId><language><json:string>eng</json:string></language><abstract>Long‐term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS‐PD) is an observational study designed to prospectively measure the evolution of motor and non‐motor features of PD and sample promising biomarkers from early to late stage illness. LABS‐PD is organized on the premise that cohorts from completed clinical trials can be re‐recruited for long‐term follow up. LABS‐PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow‐up. A biomarker sub‐study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α‐synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS‐PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society</abstract><qualityIndicators><score>8</score><pdfVersion>1.3</pdfVersion><pdfPageSize>612 x 810 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>3</keywordCount><abstractCharCount>1689</abstractCharCount><pdfWordCount>5841</pdfWordCount><pdfCharCount>39479</pdfCharCount><pdfPageCount>10</pdfPageCount><abstractWordCount>256</abstractWordCount></qualityIndicators><title>A longitudinal program for biomarker development in Parkinson's disease: A feasibility study</title><genre><json:string>article</json:string></genre><host><volume>24</volume><publisherId><json:string>MDS</json:string></publisherId><pages><total>10</total><last>2090</last><first>2081</first></pages><issn><json:string>0885-3185</json:string></issn><issue>14</issue><subject><json:item><value>Research Article</value></json:item></subject><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1531-8257</json:string></eissn><title>Movement Disorders</title><doi><json:string>10.1002/(ISSN)1531-8257</json:string></doi></host><publicationDate>2009</publicationDate><copyrightDate>2009</copyrightDate><doi><json:string>10.1002/mds.22690</json:string></doi><id>C459F8C897606D94073150044749C8A83D0A7482</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/C459F8C897606D94073150044749C8A83D0A7482/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/C459F8C897606D94073150044749C8A83D0A7482/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/C459F8C897606D94073150044749C8A83D0A7482/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">A longitudinal program for biomarker development in Parkinson's disease: A feasibility study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><availability><p>WILEY</p></availability><date>2009</date></publicationStmt><notesStmt><note type="content">*Potential conflict of interest: None reported.</note><note>National Institute of Neurological Disorders and Stroke - No. 5U01NS050095‐05;</note><note>Department of Defense Neurotoxin Exposure Treatment Parkinson's Research Program - No. W23RRYX7022N606;</note><note>Michael J Fox Foundation</note><note>Parkinson's Disease Foundation</note><note>Lundbeck Pharmaceuticals</note><note>Cephalon Inc</note><note>Lundbeck Inc</note><note>John Blume Foundation</note><note>Smart Family Foundation</note><note>RJG Foundation</note><note>Kinetics Foundation</note><note>National Parkinson Foundation</note><note>Amarin Neuroscience LTD</note><note>CHDI Foundation Inc</note><note>National Institutes of Health (NHGRI, NINDS)</note><note>Columbia Parkinson's Disease Research Center</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">A longitudinal program for biomarker development in Parkinson's disease: A feasibility study</title><author><persName><forename type="first">Bernard</forename><surname>Ravina</surname></persName><roleName type="degree">MD, MSCE</roleName><note type="correspondence"><p>Correspondence: 1351 Mt. Hope Ave., Suite 223, Rochester, NY 14620</p></note><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Caroline</forename><surname>Tanner</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>The Parkinson's Institute, Sunnyvale, California, USA</affiliation></author><author><persName><forename type="first">Diane</forename><surname>DiEuliis</surname></persName><roleName type="degree">PhD</roleName><affiliation>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</affiliation></author><author><persName><forename type="first">Shirley</forename><surname>Eberly</surname></persName><roleName type="degree">MS</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Emily</forename><surname>Flagg</surname></persName><roleName type="degree">BA</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Wendy R.</forename><surname>Galpern</surname></persName><roleName type="degree">MD, PhD</roleName><affiliation>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</affiliation></author><author><persName><forename type="first">Stanley</forename><surname>Fahn</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, Columbia University, New York, New York, USA</affiliation></author><author><persName><forename type="first">Christopher G.</forename><surname>Goetz</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurosciences, Rush University Medical Center, Chicago, Illinois, USA</affiliation></author><author><persName><forename type="first">Stephen</forename><surname>Grate</surname></persName><roleName type="degree">DVM</roleName><affiliation>Telemedicine and Advanced Technology Research Center, Fort Detrick, Maryland, USA</affiliation></author><author><persName><forename type="first">Roger</forename><surname>Kurlan</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Anthony E.</forename><surname>Lang</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Medicine, Division of Neurology, Univerisity of Toronto, Toronto, Ontario, Canada</affiliation></author><author><persName><forename type="first">Kenneth</forename><surname>Marek</surname></persName><roleName type="degree">MD</roleName><affiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</affiliation></author><author><persName><forename type="first">Karl</forename><surname>Kieburtz</surname></persName><roleName type="degree">MD, MPH</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">David</forename><surname>Oakes</surname></persName><roleName type="degree">PhD</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author><author><persName><forename type="first">Robin</forename><surname>Elliott</surname></persName><roleName type="degree">MA</roleName><affiliation>The Parkinson's Disease Foundation, New York, New York, USA</affiliation></author><author><persName><forename type="first">Ira</forename><surname>Shoulson</surname></persName><roleName type="degree">MD</roleName><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation></author></analytic><monogr><title level="j">Movement Disorders</title><title level="j" type="sub">Official Journal of the Movement Disorder Society</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="pISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><idno type="DOI">10.1002/(ISSN)1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2009-10-30"></date><biblScope unit="volume">24</biblScope><biblScope unit="issue">14</biblScope><biblScope unit="page" from="2081">2081</biblScope><biblScope unit="page" to="2090">2090</biblScope></imprint></monogr><idno type="istex">C459F8C897606D94073150044749C8A83D0A7482</idno><idno type="DOI">10.1002/mds.22690</idno><idno type="ArticleID">MDS22690</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2009</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Long‐term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS‐PD) is an observational study designed to prospectively measure the evolution of motor and non‐motor features of PD and sample promising biomarkers from early to late stage illness. LABS‐PD is organized on the premise that cohorts from completed clinical trials can be re‐recruited for long‐term follow up. LABS‐PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow‐up. A biomarker sub‐study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α‐synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS‐PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society</p></abstract><textClass xml:lang="en"><keywords scheme="keyword"><list><head>Keywords</head><item><term>Parkinson's disease</term></item><item><term>progression</term></item><item><term>biomarker</term></item></list></keywords></textClass><textClass><keywords scheme="Journal Subject"><list><head>article category</head><item><term>Research Article</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="2009-04-22">Received</change><change when="2009-06-10">Registration</change><change when="2009-10-30">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/C459F8C897606D94073150044749C8A83D0A7482/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Wiley Subscription Services, Inc., A Wiley Company</publisherName><publisherLoc>Hoboken</publisherLoc></publisherInfo><doi registered="yes">10.1002/(ISSN)1531-8257</doi><issn type="print">0885-3185</issn><issn type="electronic">1531-8257</issn><idGroup><id type="product" value="MDS"></id></idGroup><titleGroup><title type="main" xml:lang="en" sort="MOVEMENT DISORDERS">Movement Disorders</title><title type="subtitle">Official Journal of the Movement Disorder Society</title><title type="short">Mov. 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Hope Ave., Suite 223, Rochester, NY 14620</correspondenceTo><objectNameGroup><objectName elementName="appendix">APPENDIX</objectName></objectNameGroup><linkGroup><link type="toTypesetVersion" href="file:MDS.MDS22690.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="3"></count><count type="referenceTotal" number="39"></count><count type="wordTotal" number="7191"></count></countGroup><titleGroup><title type="main" xml:lang="en">A longitudinal program for biomarker development in Parkinson's disease: A feasibility study<link href="#fn5"></link></title><title type="short" xml:lang="en">Biomarker Development in PD</title></titleGroup><creators><creator xml:id="au1" creatorRole="author" affiliationRef="#af1" corresponding="yes"><personName><givenNames>Bernard</givenNames><familyName>Ravina</familyName><degrees>MD, 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affiliationRef="#af1"><personName><givenNames>Ira</givenNames><familyName>Shoulson</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="af1" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af2" countryCode="US" type="organization"><unparsedAffiliation>The Parkinson's Institute, Sunnyvale, California, USA</unparsedAffiliation></affiliation><affiliation xml:id="af3" countryCode="US" type="organization"><unparsedAffiliation>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</unparsedAffiliation></affiliation><affiliation xml:id="af4" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurology, Columbia University, New York, New York, USA</unparsedAffiliation></affiliation><affiliation xml:id="af5" countryCode="US" type="organization"><unparsedAffiliation>Department of Neurosciences, Rush University Medical Center, Chicago, Illinois, USA</unparsedAffiliation></affiliation><affiliation xml:id="af6" countryCode="US" type="organization"><unparsedAffiliation>Telemedicine and Advanced Technology Research Center, Fort Detrick, Maryland, USA</unparsedAffiliation></affiliation><affiliation xml:id="af7" countryCode="US" type="organization"><unparsedAffiliation>Department of Medicine, Division of Neurology, Univerisity of Toronto, Toronto, Ontario, Canada</unparsedAffiliation></affiliation><affiliation xml:id="af8" countryCode="US" type="organization"><unparsedAffiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</unparsedAffiliation></affiliation><affiliation xml:id="af9" countryCode="US" type="organization"><unparsedAffiliation>The Parkinson's Disease Foundation, New York, New York, USA</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en" type="author"><keyword xml:id="kwd1">Parkinson's disease</keyword><keyword xml:id="kwd2">progression</keyword><keyword xml:id="kwd3">biomarker</keyword></keywordGroup><fundingInfo><fundingAgency>National Institute of Neurological Disorders and Stroke</fundingAgency><fundingNumber>5U01NS050095‐05</fundingNumber></fundingInfo><fundingInfo><fundingAgency>Department of Defense Neurotoxin Exposure Treatment Parkinson's Research Program</fundingAgency><fundingNumber>W23RRYX7022N606</fundingNumber></fundingInfo><fundingInfo><fundingAgency>Michael J Fox Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Parkinson's Disease Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Lundbeck Pharmaceuticals</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Cephalon Inc</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Lundbeck Inc</fundingAgency></fundingInfo><fundingInfo><fundingAgency>John Blume Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Smart Family Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>RJG Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Kinetics Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>National Parkinson Foundation</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Amarin Neuroscience LTD</fundingAgency></fundingInfo><fundingInfo><fundingAgency>CHDI Foundation Inc</fundingAgency></fundingInfo><fundingInfo><fundingAgency>National Institutes of Health (NHGRI, NINDS)</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Columbia Parkinson's Disease Research Center</fundingAgency></fundingInfo><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Abstract</title><p>Long‐term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS‐PD) is an observational study designed to prospectively measure the evolution of motor and non‐motor features of PD and sample promising biomarkers from early to late stage illness. LABS‐PD is organized on the premise that cohorts from completed clinical trials can be re‐recruited for long‐term follow up. LABS‐PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow‐up. A biomarker sub‐study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α‐synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS‐PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn5"><p>Potential conflict of interest: None reported.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>A longitudinal program for biomarker development in Parkinson's disease: A feasibility study</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Biomarker Development in PD</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>A longitudinal program for biomarker development in Parkinson's disease: A feasibility study</title></titleInfo><name type="personal"><namePart type="given">Bernard</namePart><namePart type="family">Ravina</namePart><namePart type="termsOfAddress">MD, MSCE</namePart><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA</affiliation><description>Correspondence: 1351 Mt. Hope Ave., Suite 223, Rochester, NY 14620</description><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Caroline</namePart><namePart type="family">Tanner</namePart><namePart type="termsOfAddress">MD, PhD</namePart><affiliation>The Parkinson's Institute, Sunnyvale, California, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Diane</namePart><namePart type="family">DiEuliis</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Shirley</namePart><namePart type="family">Eberly</namePart><namePart type="termsOfAddress">MS</namePart><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New 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USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Anthony E.</namePart><namePart type="family">Lang</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Department of Medicine, Division of Neurology, Univerisity of Toronto, Toronto, Ontario, Canada</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kenneth</namePart><namePart type="family">Marek</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Karl</namePart><namePart type="family">Kieburtz</namePart><namePart type="termsOfAddress">MD, MPH</namePart><affiliation>Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, 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USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><place><placeTerm type="text">Hoboken</placeTerm></place><dateIssued encoding="w3cdtf">2009-10-30</dateIssued><dateCaptured encoding="w3cdtf">2009-04-22</dateCaptured><dateValid encoding="w3cdtf">2009-06-10</dateValid><copyrightDate encoding="w3cdtf">2009</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">2</extent><extent unit="tables">3</extent><extent unit="references">39</extent><extent unit="words">7191</extent></physicalDescription><abstract lang="en">Long‐term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS‐PD) is an observational study designed to prospectively measure the evolution of motor and non‐motor features of PD and sample promising biomarkers from early to late stage illness. LABS‐PD is organized on the premise that cohorts from completed clinical trials can be re‐recruited for long‐term follow up. LABS‐PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow‐up. A biomarker sub‐study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α‐synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS‐PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society</abstract><note type="content">*Potential conflict of interest: None reported.</note><note type="funding">National Institute of Neurological Disorders and Stroke - No. 5U01NS050095‐05; </note><note type="funding">Department of Defense Neurotoxin Exposure Treatment Parkinson's Research Program - No. W23RRYX7022N606; </note><note type="funding">Michael J Fox Foundation</note><note type="funding">Parkinson's Disease Foundation</note><note type="funding">Lundbeck Pharmaceuticals</note><note type="funding">Cephalon Inc</note><note type="funding">Lundbeck Inc</note><note type="funding">John Blume Foundation</note><note type="funding">Smart Family Foundation</note><note type="funding">RJG Foundation</note><note type="funding">Kinetics Foundation</note><note type="funding">National Parkinson Foundation</note><note type="funding">Amarin Neuroscience LTD</note><note type="funding">CHDI Foundation Inc</note><note type="funding">National Institutes of Health (NHGRI, NINDS)</note><note type="funding">Columbia Parkinson's Disease Research Center</note><subject lang="en"><genre>Keywords</genre><topic>Parkinson's disease</topic><topic>progression</topic><topic>biomarker</topic></subject><relatedItem type="host"><titleInfo><title>Movement Disorders</title><subTitle>Official Journal of the Movement Disorder Society</subTitle></titleInfo><titleInfo type="abbreviated"><title>Mov. Disord.</title></titleInfo><genre type="Journal">journal</genre><subject><genre>article category</genre><topic>Research Article</topic></subject><identifier type="ISSN">0885-3185</identifier><identifier type="eISSN">1531-8257</identifier><identifier type="DOI">10.1002/(ISSN)1531-8257</identifier><identifier type="PublisherID">MDS</identifier><part><date>2009</date><detail type="volume"><caption>vol.</caption><number>24</number></detail><detail type="issue"><caption>no.</caption><number>14</number></detail><extent unit="pages"><start>2081</start><end>2090</end><total>10</total></extent></part></relatedItem><identifier type="istex">C459F8C897606D94073150044749C8A83D0A7482</identifier><identifier type="DOI">10.1002/mds.22690</identifier><identifier type="ArticleID">MDS22690</identifier><accessCondition type="use and reproduction" contentType="copyright">Copyright © 2009 Movement Disorder Society</accessCondition><recordInfo><recordContentSource>WILEY</recordContentSource><recordOrigin>Wiley Subscription Services, Inc., A Wiley Company</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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