Risk Evaluation and Education for Alzheimer’s Disease (REVEAL IV)

Background

The REVEAL (Risk Evaluation and Education for Alzheimer’s Disease) Study is a series of successive NIH-funded randomized clinical trials to determine the benefits and harms of providing Alzheimer’s disease (AD) risk assessment with APOE genotype disclosure. Individuals with mild cognitive impairment (MCI) who possess the APOE e4 risk allele are at an elevated risk for more rapid conversion to clinical AD. In this fourth multi-site trial of the REVEAL series, we explore the impact of disclosing the APOE genotype to individuals with MCI and their study partners.

Study Aims

Participants with mild cognitive impairment (MCI) are randomized to one of two groups to receive a 3-year risk estimate for clinical AD. Participants in the intervention group (genotype disclosure arm) receive risk information based on their age, diagnosis of MCI, and APOE genotype, while participants in the comparison group (genotype non-disclosure arm) receive risk information based on their MCI diagnosis and age alone. The study follows participants for up to six months following risk disclosure to determine whether APOE genotype disclosure results in significant risks (e.g., psychological distress) or benefits (e.g., positive health behavior changes).

Funding Source

The REVEAL IV study was funded by the National Institutes of Health (NIH) through a grant (R01 HG02213) from the National Human Genome Research Institute (NHGRI).

Key Personnel

Scott Roberts, PhD, Principal Investigator (U-M site)
Wendy R. Uhlmann, MS, CGC, Co-Investigator, and Study Clinician
Lan Q. Le, MPH, Project Manager
Sara J. Feldman, MPH, Predoctoral Fellow

Study Publications

Christensen KD, Karlawish J, Roberts JS, et al. Disclosure of genetic risk for Alzheimer’s disease to patients with mild cognitive impairment. (2020). Alzheimer’s & Dementia: Translational Research & Clinical Interventions. E-pub ahead of print. [PMID 32211507].

Roberts JS, Patterson A, Uhlmann W. (2020). Genetic testing for neurodegenerative diseases: Ethical and health communication challenges. Neurobiology of Disease, 141. [PMID 32302673].

Guan Y, Roter DL, Erby LH, Wolff JL, Roberts JS, Green RC, Christensen KD. (2018). Communication predictors of patient and companion satisfaction with Alzheimer’s disease genetic risk disclosure. Journal of Health Communication, 23(8), 807-14. [PMID 30325721].