REVEAL-SCAN: Risk Evaluation and Education of Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (RF1 AG047866)
Principal Investigators: Robert C. Green and Jason Karlawish
Co-Principal Investigators: J. Scott Roberts and Kathleen Welsh-Bohmer
Alzheimer’s disease (AD) clinical trials have traditionally tested potential treatments for individuals with symptoms of dementia, but the discovery of AD biomarkers has dramatically altered this approach. Trials such as the Anti-Amyloid in Asymptomatic Alzheimer’s Study, or A4 Study, are now focusing on enrolling cognitively normal participants who have biomarkers suggestive of “preclinical AD,” in order to delay the onset of cognitive impairments. This goal presents two questions of critical importance to both the validity and safety of these trials, and the successful translation of their results into clinical practice: (1) Will individuals’ knowledge of their biomarker status bias cognitive outcomes? (2) Will such knowledge prompt beneficial behavior changes or cause adverse psychological and social consequences?
REVEAL-SCAN: Risk Evaluation and and Education of Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (RF1 AG047866) is the first multi-site, randomized clinical trial to examine the impact of learning amyloid imaging results in cognitively normal individuals, and its goal is to answer these questions.
If simply learning that one is biomarker positive causes a person to perform worse on cognitive testing, then primary outcomes data of AD trials may not be valid. Moreover, since amyloid imaging received FDA approval for use in cognitively impaired individuals, our preliminary studies show that clinical investigators want guidance on whether and how to disclose amyloid imaging results, not only to these individuals, but also to cognitively normal older individuals.
In this study, risk communication protocols will be developed and implemented for communicating amyloid PET brain imaging results. Then, 270 cognitively normal individuals (approximately 25% African American), aged 65-80, will be recruited and randomized to receive their amyloid scan results or not, resulting in subjects whose scan results are disclosed or not and subjects whose scans are amyloid positive or not. Apolipoprotein (APOE) genotyping with oversampling of ε4+ individuals will be used to enrich the enrollment sample, such that roughly half of those scanned will be amyloid positive and half will be amyloid negative. The primary neuropsychological outcome will be the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and the primary psychological outcome for psychological distress will be the Impact of Events Scale (IES).
The core team that will conduct this project has worked together for over ten years on the NIH-funded REVEAL Study (R01 HG02213) trials that have studied risk estimation, risk communication and the disclosure of APOE genotype for risk of AD. Our aims are as follows: 1) to determine whether disclosure of elevated brain amyloid will bias ADCS-PACC test results; 2) to determine whether disclosure of elevated brain amyloid will cause psychological distress; and 3) to explore how learning amyloid imaging disclosure will impact preventative health behaviors, advance planning for health (e.g. long-term care insurance decisions) and well-being (e.g. stigma, quality of life and relationships).
REVEAL-SCAN is currently enrolling participants. For a downloadable brochure, please click "here". To learn more about this study or if you are interested in participating, please contact Sheila Sutti, MS, CGC, Genetic Counselor and Project Manager for the REVEAL-SCAN Study.