Apathy in Neurodegenerative Diseases: Recommendations on the Design of Clinical Trials.
Identifieur interne : 000305 ( PubMed/Corpus ); précédent : 000304; suivant : 000306Apathy in Neurodegenerative Diseases: Recommendations on the Design of Clinical Trials.
Auteurs : Jeffrey Cummings ; Joseph H. Friedman ; George Garibaldi ; Martin Jones ; Wayne Macfadden ; Laura Marsh ; Philippe H. RobertSource :
- Journal of geriatric psychiatry and neurology [ 0891-9887 ] ; 2015.
English descriptors
- KwdEn :
- MESH :
- complications : Parkinson Disease.
- diagnosis : Depression, Depressive Disorder.
- psychology : Alzheimer Disease, Depression, Depressive Disorder.
- Apathy, Clinical Trials as Topic, Humans, Male, Research Design.
Abstract
Apathy is a common feature of neurodegenerative disorders but is difficult to study in a clinical trial setting due to practical and conceptual barriers. Principal challenges include a paucity of data regarding apathy in these disorders, an absence of established diagnostic criteria, the presence of confounding factors (eg, coexisting depression), use of concomitant medications, and an absence of a gold-standard apathy assessment scale. Based on a literature search and ongoing collaboration among the authors, we present recommendations for the design of future clinical trials of apathy, suggesting Alzheimer disease and Parkinson disease as models with relevance across a wider array of neuropsychiatric disorders. Recommendations address clarification of the targeted study population (apathy diagnosis and severity at baseline), confounding factors (mood/cognition, behavior, and treatment), outcome measures, study duration, use of comparators and considerations around environment, and the role of the caregiver and patient assent. This review contributes to the search for an optimal approach to study treatment of apathy in neuropsychiatric disorders.
DOI: 10.1177/0891988715573534
PubMed: 25809634
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Friedman</name><affiliation><nlm:affiliation>Department of Neurology, Movement Disorders Program, Butler Hospital, Alpert Medical School of Brown University, Providence, RI, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Garibaldi, George" sort="Garibaldi, George" uniqKey="Garibaldi G" first="George" last="Garibaldi">George Garibaldi</name><affiliation><nlm:affiliation>Clinical Development, Neurosciences, F. Hoffman-La Roche AG, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Martin" sort="Jones, Martin" uniqKey="Jones M" first="Martin" last="Jones">Martin Jones</name><affiliation><nlm:affiliation>Bridge Medical Consulting Ltd, London, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Macfadden, Wayne" sort="Macfadden, Wayne" uniqKey="Macfadden W" first="Wayne" last="Macfadden">Wayne Macfadden</name><affiliation><nlm:affiliation>Clinical Development, Neurosciences, F. Hoffman-La Roche AG, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Marsh, Laura" sort="Marsh, Laura" uniqKey="Marsh L" first="Laura" last="Marsh">Laura Marsh</name><affiliation><nlm:affiliation>Mental Health Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Robert, Philippe H" sort="Robert, Philippe H" uniqKey="Robert P" first="Philippe H" last="Robert">Philippe H. Robert</name><affiliation><nlm:affiliation>CoBTeK, Research Memory Center CMRR CHU, University of Sophia Antipolis, Nice, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2015">2015</date><idno type="RBID">pubmed:25809634</idno><idno type="pmid">25809634</idno><idno type="doi">10.1177/0891988715573534</idno><idno type="wicri:Area/PubMed/Corpus">000305</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000305</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Apathy in Neurodegenerative Diseases: Recommendations on the Design of Clinical Trials.</title><author><name sortKey="Cummings, Jeffrey" sort="Cummings, Jeffrey" uniqKey="Cummings J" first="Jeffrey" last="Cummings">Jeffrey Cummings</name><affiliation><nlm:affiliation>Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA cumminj@ccf.org.</nlm:affiliation></affiliation></author><author><name sortKey="Friedman, Joseph H" sort="Friedman, Joseph H" uniqKey="Friedman J" first="Joseph H" last="Friedman">Joseph H. Friedman</name><affiliation><nlm:affiliation>Department of Neurology, Movement Disorders Program, Butler Hospital, Alpert Medical School of Brown University, Providence, RI, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Garibaldi, George" sort="Garibaldi, George" uniqKey="Garibaldi G" first="George" last="Garibaldi">George Garibaldi</name><affiliation><nlm:affiliation>Clinical Development, Neurosciences, F. Hoffman-La Roche AG, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Jones, Martin" sort="Jones, Martin" uniqKey="Jones M" first="Martin" last="Jones">Martin Jones</name><affiliation><nlm:affiliation>Bridge Medical Consulting Ltd, London, United Kingdom.</nlm:affiliation></affiliation></author><author><name sortKey="Macfadden, Wayne" sort="Macfadden, Wayne" uniqKey="Macfadden W" first="Wayne" last="Macfadden">Wayne Macfadden</name><affiliation><nlm:affiliation>Clinical Development, Neurosciences, F. Hoffman-La Roche AG, Basel, Switzerland.</nlm:affiliation></affiliation></author><author><name sortKey="Marsh, Laura" sort="Marsh, Laura" uniqKey="Marsh L" first="Laura" last="Marsh">Laura Marsh</name><affiliation><nlm:affiliation>Mental Health Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Robert, Philippe H" sort="Robert, Philippe H" uniqKey="Robert P" first="Philippe H" last="Robert">Philippe H. Robert</name><affiliation><nlm:affiliation>CoBTeK, Research Memory Center CMRR CHU, University of Sophia Antipolis, Nice, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Journal of geriatric psychiatry and neurology</title><idno type="ISSN">0891-9887</idno><imprint><date when="2015" type="published">2015</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Alzheimer Disease (psychology)</term><term>Apathy</term><term>Clinical Trials as Topic</term><term>Depression (diagnosis)</term><term>Depression (psychology)</term><term>Depressive Disorder (diagnosis)</term><term>Depressive Disorder (psychology)</term><term>Humans</term><term>Male</term><term>Parkinson Disease (complications)</term><term>Research Design</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Depression</term><term>Depressive Disorder</term></keywords><keywords scheme="MESH" qualifier="psychology" xml:lang="en"><term>Alzheimer Disease</term><term>Depression</term><term>Depressive Disorder</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Apathy</term><term>Clinical Trials as Topic</term><term>Humans</term><term>Male</term><term>Research Design</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Apathy is a common feature of neurodegenerative disorders but is difficult to study in a clinical trial setting due to practical and conceptual barriers. Principal challenges include a paucity of data regarding apathy in these disorders, an absence of established diagnostic criteria, the presence of confounding factors (eg, coexisting depression), use of concomitant medications, and an absence of a gold-standard apathy assessment scale. Based on a literature search and ongoing collaboration among the authors, we present recommendations for the design of future clinical trials of apathy, suggesting Alzheimer disease and Parkinson disease as models with relevance across a wider array of neuropsychiatric disorders. Recommendations address clarification of the targeted study population (apathy diagnosis and severity at baseline), confounding factors (mood/cognition, behavior, and treatment), outcome measures, study duration, use of comparators and considerations around environment, and the role of the caregiver and patient assent. This review contributes to the search for an optimal approach to study treatment of apathy in neuropsychiatric disorders.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25809634</PMID><DateCreated><Year>2015</Year><Month>08</Month><Day>21</Day></DateCreated><DateCompleted><Year>2016</Year><Month>01</Month><Day>08</Day></DateCompleted><DateRevised><Year>2015</Year><Month>08</Month><Day>21</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Print">0891-9887</ISSN><JournalIssue CitedMedium="Internet"><Volume>28</Volume><Issue>3</Issue><PubDate><Year>2015</Year><Month>Sep</Month></PubDate></JournalIssue><Title>Journal of geriatric psychiatry and neurology</Title><ISOAbbreviation>J Geriatr Psychiatry Neurol</ISOAbbreviation></Journal><ArticleTitle>Apathy in Neurodegenerative Diseases: Recommendations on the Design of Clinical Trials.</ArticleTitle><Pagination><MedlinePgn>159-73</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1177/0891988715573534</ELocationID><Abstract><AbstractText>Apathy is a common feature of neurodegenerative disorders but is difficult to study in a clinical trial setting due to practical and conceptual barriers. Principal challenges include a paucity of data regarding apathy in these disorders, an absence of established diagnostic criteria, the presence of confounding factors (eg, coexisting depression), use of concomitant medications, and an absence of a gold-standard apathy assessment scale. Based on a literature search and ongoing collaboration among the authors, we present recommendations for the design of future clinical trials of apathy, suggesting Alzheimer disease and Parkinson disease as models with relevance across a wider array of neuropsychiatric disorders. Recommendations address clarification of the targeted study population (apathy diagnosis and severity at baseline), confounding factors (mood/cognition, behavior, and treatment), outcome measures, study duration, use of comparators and considerations around environment, and the role of the caregiver and patient assent. This review contributes to the search for an optimal approach to study treatment of apathy in neuropsychiatric disorders.</AbstractText><CopyrightInformation>© The Author(s) 2015.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Cummings</LastName><ForeName>Jeffrey</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas, NV, USA cumminj@ccf.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Friedman</LastName><ForeName>Joseph H</ForeName><Initials>JH</Initials><AffiliationInfo><Affiliation>Department of Neurology, Movement Disorders Program, Butler Hospital, Alpert Medical School of Brown University, Providence, RI, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garibaldi</LastName><ForeName>George</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Clinical Development, Neurosciences, F. Hoffman-La Roche AG, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jones</LastName><ForeName>Martin</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Bridge Medical Consulting Ltd, London, United Kingdom.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Macfadden</LastName><ForeName>Wayne</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Clinical Development, Neurosciences, F. Hoffman-La Roche AG, Basel, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marsh</LastName><ForeName>Laura</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Mental Health Care Line, Michael E. DeBakey Veterans Affairs Medical Center, Houston, TX, USA Menninger Department of Psychiatry, Baylor College of Medicine, Houston, TX, USA Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robert</LastName><ForeName>Philippe H</ForeName><Initials>PH</Initials><AffiliationInfo><Affiliation>CoBTeK, Research Memory Center CMRR CHU, University of Sophia Antipolis, Nice, France.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>03</Month><Day>24</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>J Geriatr Psychiatry Neurol</MedlineTA><NlmUniqueID>8805645</NlmUniqueID><ISSNLinking>0891-9887</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000544" MajorTopicYN="N">Alzheimer Disease</DescriptorName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D057565" MajorTopicYN="Y">Apathy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002986" MajorTopicYN="Y">Clinical Trials as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D003863" MajorTopicYN="N">Depression</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003866" MajorTopicYN="N">Depressive Disorder</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000523" MajorTopicYN="N">psychology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010300" MajorTopicYN="N">Parkinson Disease</DescriptorName><QualifierName UI="Q000150" MajorTopicYN="N">complications</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="Y">Research Design</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Alzheimer disease</Keyword><Keyword MajorTopicYN="N">Parkinson disease</Keyword><Keyword MajorTopicYN="N">apathy</Keyword><Keyword MajorTopicYN="N">trial design</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2014</Year><Month>06</Month><Day>16</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2014</Year><Month>10</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>3</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>3</Month><Day>27</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>1</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">25809634</ArticleId><ArticleId IdType="pii">0891988715573534</ArticleId><ArticleId IdType="doi">10.1177/0891988715573534</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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