Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN)

Alzheimer's disease (AD) is a brain disease and is the most common form of dementia. Clinical
trials for the prevention of AD have been moving to enroll subjects at increasingly earlier
time-points, and are now focusing upon individuals who are not only cognitively normal but
also have biomarkers associated with an increased risk of developing AD. Detecting one
specific biomarker on brain scans, i.e. amyloid-beta protein, is currently used to inform
diagnoses in cognitively impaired individuals, and its use may expand to pre-clinical AD
cases as preventive therapies are developed.

In the REVEAL-SCAN clinical trial, the investigators are examining the psychological and
behavioral impact of learning "elevated" and "not elevated" amyloid neuroimaging results
pertaining to the risk of progressing to Alzheimer's disease dementia by age 85 among
cognitively normal older adults. The study's goal is to learn how to communicate these
amyloid brain scan results and the risk of developing AD dementia by age 85 in a diverse
population of cognitively normal older adults. Findings will be relevant to future
decision-making in research trials and clinical practices.

Study sites will enroll older, cognitively normal individuals (270 total) using APOE
genotyping to enrich the enrollment sample such that roughly half of those scanned will have
elevated amyloid brain scan results and half of those scanned will have not elevated amyloid
results. From this enriched sample, participants (approximately 25% African-American) will
all receive their Alzheimer's Disease Dementia Risk Assessment based on known risk factors.
Half of the participants will be randomized to also learn their amyloid brain scan result at
that time, while the other half will learn their scan result 6 months later. Cognitive,
psychological, and behavioral outcomes will be compared between these two groups.
Participants will be followed for up to 9 months with up to 7 in-person visits and 5 phone
calls.

REVEAL-SCAN is the first multisite randomized clinical trial to explore the benefits, risks
and limitations of disclosing amyloid results, and will help researchers and clinicians
understand downstream implications of this emerging technology as it becomes increasingly
utilized to compile comprehensive neuroimaging profiles for older adults at risk for
developing Alzheimer's disease dementia.

Inclusion Criteria:

- English-speaking individuals (65-80 years old) with normal cognition

- Individuals with at least one first-degree relative with Alzheimer's disease (parent,
sibling, child)

- Individuals who have a close friend, relative or spouse (18+) willing to be a study
partner. Study partners complete surveys and interviews, accompany the study subject
to the second in-person study visit, and may be asked to attend other/all study
visits.

- Individuals who are willing to give a cheek swab sample to undergo blinded
(undisclosed) APOE genotyping

- Individuals willing to participate in a randomized clinical trial of amyloid imaging
disclosure

Exclusion Criteria:

- Individuals who have suffered from a stroke or head trauma

- Individuals who have active medical or psychiatric illness that is unstable or
progressive

- Individuals who are taking acetylcholinesterase inhibitors of memantine