A Pragmatic, Investigator-Driven Process for Disclosure of Amyloid PET Scan Results to ADNI-4 Research Participants - 21/11/24
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Abstract |
Background |
Prior studies of Alzheimer’s disease (AD) biomarker disclosure have answered important questions about individuals’ safety after learning and comprehending their amyloid PET results; however, these studies have typically employed highly structured disclosure protocols and focused on the psychological impact of disclosure (e.g., anxiety, depression, and suicidality) in homogeneous populations. More work is needed to develop flexible disclosure protocols and study outcomes in ethnoculturally representative samples.
Methods |
The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is formally incorporating amyloid PET disclosure into the newest protocol (ADNI-4). Participants across the cognitive spectrum who wish to know their amyloid PET results may learn them. The pragmatic disclosure process spans four timepoints: (1) a pre-disclosure visit, (2) the PET scan and its read, (3) a disclosure visit, and (4) a post-disclosure check-in. This process applies to all participants, with slight modifications to account for their cognitive status. In designing this process, special emphasis was placed on utilizing investigator discretion. Participant measures include perceived risk of dementia, purpose in life, and disclosure satisfaction. Investigator assessment of the disclosure visit (e.g., challenges encountered, topics discussed, etc.) is also included.
Results |
Data collection is ongoing. Results will allow for more robust characterization of the impact of learning amyloid PET results on individuals and describe the perspectives of investigators.
Conclusion |
The pragmatic design of the disclosure process in ADNI-4 coupled with the novel participant and investigator data will inform future disclosure practices. This is especially important as disclosure of biomarker results expands in research and care.
Le texte complet de cet article est disponible en PDF.Key words : Alzheimer’s disease, biomarker disclosure, pragmatic
Plan
| Disclosures: JK reports grants from Lilly, Biogen, and Eisai. JDG reports grant funding from the National Institutes of Health (P30 AG066519), Lilly, Eisai, Biogen, BrightFocus Foundation, and the Alzheimer’s Association. SML is on advisory boards for KeifeRX advisory board and the IPAT study. She has received speaker fees from Eisai. MRM reports grant funding from the National Institutes of Health (NIH), Genentech, and the Alzheimer’s Association. She is on the Advisory Boards for: NIH Alzheimer’s Disease Research Centers (Mayo Clinic, University of Texas Rio Grand Valley, University of Washington, and UC San Francisco); Brown University Center for Alzheimer’s Disease Research Center/Carney Institute for Brain Science; National Centralized Repository for ADRD (NCRAD); and the Harlem Community & Academic Partnership. OO reports funding from the National Institutes of Health. RCP reports grants from the National Institute on Aging and personal fees from Roche, Genentech, Lilly, Nestle, and Eisai. He has received royalties from Oxford University Press, UpToDate, and Medscape. PSA reports grants from the National Institutes of Health, Alzheimer’s Association, Janseen, Lilly, and Eisai. He also reports consulting relationships with Merck, Bristol Myers Squibb, Switch Therapeutics, NewAmsterdam Pharma, Roche, Genentech, Abbvie, Biogen, ImmunoBrain Checkpoint, and Arrowhead. MWW reports grants from National Institutes of Health, Department of Defense, California Department of Public Health, Siemens, Biogen, Hillblom Foundation, Alzheimer’s Association, Johnson & Johnson, Kevin and Connie Shanahan, GE, VUmc, Australian Catholic University (HBI-BHR), The Stroke Foundation, and Veterans Administration. He also reports personal fees from Boxer Capital, Cerecin, Clario/BioClinica, Dementia Society of Japan, Eisai, Guidepoint, Health and Wellness Partners, Indiana University, LCN Consulting, Merck Sharp & Dohme Corp., Duke University, Prova Education, T3D Therapeutics, University of Southern California, WebMD, and MEDA Corp., and travel support from AD/PD Congress (Kenes Group), CTAD Congress, Foundation of Learning; Health Society (Japan), INSPIRE Project; University of Toulouse, Japan Society for Dementia Research, Korean Dementia Society, Merck Sharp & Dohme Corp., National Center for Geriatrics and Gerontology Japan, and University of Southern California. MWW reports holding stock options from Alzeca, Alzheon, Inc., ALZPath, and Anven. EAL reports grants from the Greenwall Foundation and National Institute on Aging. The other authors (CME, KH) report no relevant disclosures. How to cite this article: C.M. Erickson, J. Karlawish, J.D. Grill, et al. A Pragmatic, Investigator-Driven Process for Disclosure of Amyloid PET Scan Results to ADNI-4 Research Participants. J Prev Alz Dis 2024; jpad.2024.33 |
Vol 11 - N° 2
P. 294-302 - mars 2024 Retour au numéro
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