ASSESSING THE IMPACT OF DISCLOSING AMYLOID IMAGING RESULTS TO COGNITIVELY NORMAL OLDER ADULTS: THE REVEAL-SCAN STUDY

Abstract

Large-scale clinical trials now use PET neuroimaging and genetic testing to identify high-risk populations in which to test potential preventive therapies for Alzheimer's disease (AD). Many practical and ethical issues are involved in decisions about if, when, and how to communicate such biomarker information to cognitively normal individuals. Our multi-site, interdisciplinary group has conducted a series of randomized trials known as the REVEAL Study, examining the psychological and behavioral impact of disclosing APOE genotype information to asymptomatic adults with a family history of AD. This presentation describes protocol development for a newly launched REVEAL trial assessing effects of disclosing amyloid neuroimaging results to a diverse sample of at-risk older adults. A four-site randomized trial will enroll 270 adults aged 65–80 (at least 25% African American) with a first-degree relative diagnosed with AD or related dementia. APOE genotyping will enrich the study sample for increased likelihood of elevated amyloid PET scan results, but APOE results will not be shared with participants. Trial participants will be educated about amyloid neuroimaging and then randomized to receive either immediate or delayed disclosure of scan results. A series of longitudinal surveys and neuropsychological assessments will assess study outcomes of interest. Study protocol development has generated: 1) in-depth education materials and counseling aids focused on explaining the process, purpose, and limitations of amyloid neuroimaging; describing the implications of test results for future risk of AD; and providing resources and recommendations for AD risk modification; 2) a battery of validated and newly created measures that assess participants’ cognitive functioning, understanding of test results, psychological reactions, health behavior changes, and health utilization; and 3) mechanisms for addressing human subjects protection issues (e.g., external study advisory board, Certificate of Confidentiality, mental health resources in case of catastrophic reactions). This project is designed to yield information on the benefits, risks, and limitations of disclosing amyloid neuroimaging results to cognitively normal older adults across diverse cultural backgrounds. Study results will show the effects of amyloid imaging on cognition, social relationships, and behavior: findings that will help inform best practices for disclosure of AD biomarker information in research and clinical contexts.