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

April 1, 2024 updated by: Robert C. Green, MD, MPH, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amyloid Brain Imaging Non-Disclosure
Subjects will receive their Alzheimer's disease (AD) risk assessment based on age, gender, family history and ancestry.
Behavioral: Alzheimer's Disease Risk Disclosure
Subjects will learn a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Experimental: Amyloid Brain Imaging Disclosure
Subjects will receive both their "elevated" or "not elevated" amyloid neuroimaging results based on their brain scan interpretation and Alzheimer's disease (AD) risk disclosure. The AD risk assessment is based on age, gender, family history and ancestry.
Behavioral: Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure
Subjects will learn their own "elevated" or "not elevated" amyloid results and a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline neuropsychological performance compared to 6 weeks and 6 months post-disclosure
Time Frame: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
Assessed via the A4 Study's Preclinical Alzheimer Cognitive Composite (ADCS-PACC) battery, which combines tests that measure episodic memory, timed executive function, and global cognition.
Baseline, 6 weeks post-disclosure, 6-months post-disclosure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline measure scores on scales and questionnaires of psychological distress compared to 6 weeks and 6 months post-disclosure.
Time Frame: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
Psychological distress will be measured between and within participants at the same and different study time points, and will be based on participants' scores on scales and questionnaires in terms of the following related variables of psychological distress: anxiety and depression, test-specific distress, psychological impact of disclosure, quality of life, perceived time and subjective cognition.
Baseline, 6 weeks post-disclosure, 6-months post-disclosure
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.
Time Frame: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
Assessed in participant surveys via questions evaluating: health behavior changes, advanced planning, insurance changes (i.e. purchasing or altering long-term care policies), medication changes, willingness to enroll in clinical research and tolerance of research risk.
Baseline, 6 weeks post-disclosure, 6-months post-disclosure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Boston University
University of Pennsylvania
University of Michigan
Duke University
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jason Karlawish, MD, University of Pennsylvania
  • Principal Investigator: J. Scott Roberts, PhD, University of Michigan
  • Principal Investigator: Kathleen Welsh-Boomer, PhD, Duke University
  • Principal Investigator: Robert C Green, MD, MPH, Brigham and Women's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

May 13, 2020

Study Completion (Actual)

April 29, 2021

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

November 7, 2016

First Posted (Estimated)

November 9, 2016

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RF1AG047866 (U.S. NIH Grant/Contract)
  • 1RF1AG047866-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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