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Biomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials
dc.contributor.authorRahman-Filipiak, Annalise
dc.contributor.authorBolton, Corey
dc.contributor.authorGrill, Joshua D.
dc.contributor.authorRostamzadeh, Ayda
dc.contributor.authorChin, Nathaniel
dc.contributor.authorHeidebrink, Judith
dc.contributor.authorGetz, Sarah
dc.contributor.authorFowler, Nicole R.
dc.contributor.authorRosen, Allyson
dc.contributor.authorLingler, Jennifer
dc.contributor.authorWijsman, Ellen
dc.contributor.authorClark, Lindsay
dc.date.accessioned2023-10-02T15:27:27Z
dc.date.available2024-10-02 11:27:26en
dc.date.available2023-10-02T15:27:27Z
dc.date.issued2023-09
dc.identifier.citationRahman-Filipiak, Annalise ; Bolton, Corey; Grill, Joshua D.; Rostamzadeh, Ayda; Chin, Nathaniel; Heidebrink, Judith; Getz, Sarah; Fowler, Nicole R.; Rosen, Allyson; Lingler, Jennifer; Wijsman, Ellen; Clark, Lindsay (2023). "Biomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials." Alzheimer’s & Dementia 19(9): 4270-4275.
dc.identifier.issn1552-5260
dc.identifier.issn1552-5279
dc.identifier.urihttps://hdl.handle.net/2027.42/178240
dc.description.abstractINTRODUCTIONThe development of biomarkers for Alzheimer’s disease (AD) has allowed researchers to increase sample homogeneity and test candidate treatments earlier in the disease. The integration of biomarker “screening” criteria should be met with a parallel implementation of standardized methods to disclose biomarker testing results to research participants; however, the extent to which protocolized disclosure occurs in trials is unknown.METHODSWe reviewed the literature to identify prodromal AD trials published in the past 10 years. From these, we quantified the frequency of biomarker disclosure reporting and the depth of descriptions provided.RESULTSOf 30 published trials using positron emission tomography or cerebrospinal fluid-based amyloid positivity as an eligibility criterion, only one mentioned disclosure, with no details on methods.DISCUSSIONPossible reasons for and implications of this information gap are discussed. Recommendations are provided for trialists considering biomarker screening as part of intervention trials focused on prodromal AD.HIGHLIGHTSFew prodromal Alzheimer’s disease (AD) trial papers discuss biomarker disclosure.Disclosure has implications for participants, family members, and trial success.Disclosure must be consistently integrated and reported in prodromal AD trials.Best practice guidelines and training resources for disclosure are needed.
dc.publisherWiley Periodicals, Inc.
dc.subject.otheramyloid
dc.subject.otherbiomarker disclosure
dc.subject.othermild cognitive impairment
dc.subject.otherprodromal Alzheimer’s disease
dc.subject.otherrandomized controlled trials
dc.titleBiomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelNeurology and Neurosciences
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/178240/1/alz13380-sup-0002-coi-disclosure.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/178240/2/alz13380_am.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/178240/3/alz13380.pdf
dc.identifier.doi10.1002/alz.13380
dc.identifier.sourceAlzheimer’s & Dementia
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dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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