title: Disclosure of amyloid status is not a barrier to recruitment in preclinical Alzheimer's disease clinical trials.
abstract: Preclinical Alzheimer's disease (AD) clinical trials may require participants to learn if they meet biomarker enrollment criteria. To examine whether this requirement will impact trial recruitment, we presented 132 older community volunteers who self-reported normal cognition with 1 of 2 hypothetical informed consent forms (ICFs) describing an AD prevention clinical trial. Both ICFs described amyloid Positron Emission Tomography scans. One ICF stated that scan results would not be shared with the participants (blinded enrollment); the other stated that only persons with elevated amyloid would be eligible (transparent enrollment). Participants rated their likelihood of enrollment and completed an interview with a research assistant. We found no difference between the groups in willingness to participate. Study risks and the requirement of a study partner were reported as the most important factors in the decision whether to enroll. The requirement of biomarker disclosure may not slow recruitment to preclinical AD trials.
authors.affiliation: Department of Psychiatry and Human Behavior, Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine, CA, USA. Electronic address: jgrill@uci.edu.
authors.forename: Joshua D
authors.initials: JD
authors.lastname: Grill
authors.affiliation: Department of Neurology, Mary S. Easton Center for Alzheimer's Disease Research, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: yan.zhou@theABA.org.
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Department of Neurology, Mary S. Easton Center for Alzheimer's Disease Research, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; Department of Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
authors.forename: David
authors.initials: D
authors.lastname: Elashoff
authors.affiliation: Penn Neurodegenerative Disease Ethics and Policy Program, Department of Medicine, Penn Memory Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA; Penn Neurodegenerative Disease Ethics and Policy Program, Department of Medical Ethics and Health Policy, Penn Memory Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Jason
authors.initials: J
authors.lastname: Karlawish
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000000981:diagnostic imaging / Q000378:metabolism / Q000517:prevention & control*; D058227:Amyloidogenic Proteins / Q000378:metabolism*; D015415:Biomarkers; D002986:Clinical Trials as Topic; D030881:Disclosure; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D010358:Patient Participation / Q000523:psychology* / Q000706:statistics & numerical data*; D018579:Patient Selection; D049268:Positron-Emission Tomography
chemical_list: D058227:Amyloidogenic Proteins; D015415:Biomarkers
keywords: Biomarker; Disclosure; Preclinical Alzheimer's disease; Recruitment