Literature DB >> 26923411

Disclosure of amyloid status is not a barrier to recruitment in preclinical Alzheimer's disease clinical trials.

Joshua D Grill1, Yan Zhou2, David Elashoff3, Jason Karlawish4.   

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.
Copyright © 2016 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  Biomarker; Disclosure; Preclinical Alzheimer's disease; Recruitment

Mesh:

Substances:

Year:  2015        PMID: 26923411      PMCID: PMC4773920          DOI: 10.1016/j.neurobiolaging.2015.11.007

Source DB:  PubMed          Journal:  Neurobiol Aging        ISSN: 0197-4580            Impact factor:   4.673


  31 in total

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2.  Effect of knowledge of APOE genotype on subjective and objective memory performance in healthy older adults.

Authors:  Tara T Lineweaver; Mark W Bondi; Douglas Galasko; David P Salmon
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3.  Risk disclosure and preclinical Alzheimer's disease clinical trial enrollment.

Authors:  Joshua D Grill; Jason Karlawish; David Elashoff; Barbara G Vickrey
Journal:  Alzheimers Dement       Date:  2012-11-08       Impact factor: 21.566

4.  Public beliefs and knowledge about risk and protective factors for Alzheimer's disease.

Authors:  J Scott Roberts; Sara J McLaughlin; Cathleen M Connell
Journal:  Alzheimers Dement       Date:  2014-03-14       Impact factor: 21.566

5.  Older adults with cognitive complaints show brain atrophy similar to that of amnestic MCI.

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Review 6.  Alzheimer's Prevention Initiative: a plan to accelerate the evaluation of presymptomatic treatments.

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Review 7.  Ethics of genetic and biomarker test disclosures in neurodegenerative disease prevention trials.

Authors:  Scott Y H Kim; Jason Karlawish; Benjamin E Berkman
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8.  Confidentiality in preclinical Alzheimer disease studies: when research and medical records meet.

Authors:  Jalayne J Arias; Jason Karlawish
Journal:  Neurology       Date:  2014-01-29       Impact factor: 9.910

9.  Amyloid-related imaging abnormalities in patients with Alzheimer's disease treated with bapineuzumab: a retrospective analysis.

Authors:  Reisa Sperling; Stephen Salloway; David J Brooks; Donatella Tampieri; Jerome Barakos; Nick C Fox; Murray Raskind; Marwan Sabbagh; Lawrence S Honig; Anton P Porsteinsson; Ivan Lieberburg; H Michael Arrighi; Kristen A Morris; Yuan Lu; Enchi Liu; Keith M Gregg; H Robert Brashear; Gene G Kinney; Ronald Black; Michael Grundman
Journal:  Lancet Neurol       Date:  2012-02-03       Impact factor: 44.182

10.  Would you want to know? Public attitudes on early diagnostic testing for Alzheimer's disease.

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  21 in total

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2.  Research Attitudes Questionnaire scores predict Alzheimer's disease clinical trial dropout.

Authors:  Shana D Stites; R Scott Turner; Jeanine Gill; Anna Gurian; Jason Karlawish; Joshua D Grill
Journal:  Clin Trials       Date:  2021-01-10       Impact factor: 2.486

3.  You've Got a Friend in Me: How Cognitively Unimpaired Older Adults Select a Study Partner to Participate with Them in Alzheimer's Disease Research.

Authors:  Emily A Largent; Twisha Bhardwaj; Justin T Clapp; Olivia Saúl Sykes; Kristin Harkins; Joshua D Grill
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4.  "From Victimhood to Warriors": Super-researchers' Insights Into Alzheimer's Disease Clinical Trial Participation Motivations.

Authors:  Shoshana H Bardach; Kelly Parsons; Allison Gibson; Gregory A Jicha
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5.  Communicating 5-Year Risk of Alzheimer's Disease Dementia: Development and Evaluation of Materials that Incorporate Multiple Genetic and Biomarker Research Results.

Authors:  Jessica Mozersky; Sarah Hartz; Erin Linnenbringer; Lillie Levin; Marissa Streitz; Kristin Stock; Krista Moulder; John C Morris
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6.  Is Reluctance to Share Alzheimer's Disease Biomarker Status with a Study Partner a Barrier to Preclinical Trial Recruitment?

Authors:  C G Cox; M M Ryan; D L Gillen; J D Grill
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7.  What Influences the Willingness of Blacks and African Americans to Enroll in Preclinical Alzheimer's Disease Biomarker Research? A Qualitative Vignette Analysis.

Authors:  Fred B Ketchum; Claire M Erickson; Nathaniel A Chin; Carey E Gleason; Nickolas H Lambrou; Susan Flowers Benton; Lindsay R Clark
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8.  Disparities by Race and Ethnicity Among Adults Recruited for a Preclinical Alzheimer Disease Trial.

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Review 9.  Study partners should be required in preclinical Alzheimer's disease trials.

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10.  Attitudes toward clinical trials across the Alzheimer's disease spectrum.

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Journal:  Alzheimers Res Ther       Date:  2017-10-04       Impact factor: 6.982

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