Clinical trial NCT02959489: Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN)
Official title: Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Amyloid Beta-Peptides
Risk Assessment
Education
Neuropsychological Tests
Neuroimaging
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Michigan
name: Duke University
name: Boston University
name: National Institute on Aging (NIA)
First posted: 2016-11-09
Enrollment: 315
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is intended to examine the impact of learning amyloid brain imaging results among asymptomatic older adults, and how to safely communicate these results and educate on the risk of developing Alzheimer's disease.

Detailed description: 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 (approx. 370 total) using APOE genotyping to enrich the enrollment sample such that roughly 100 of those scanned will have elevated amyloid brain scan 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in baseline neuropsychological performance compared to 6 weeks and 6 months post-disclosure
timeFrame: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
Secondary outcomes:
measure: Change in baseline measure scores on scales and questionnaires of psychological distress compared to 6 weeks and 6 months post-disclosure.
timeFrame: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
measure: Change in baseline measures of health behaviors compared to 6 weeks and 6 months post-disclosure to determine the type and frequency of behavior changes in response to learning risk information.
timeFrame: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Brigham and Women's Hospital
name: Robert C Green, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Jason Karlawish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: J. Scott Roberts, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Kathleen Welsh-Boomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: