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

NCT02959489 | Completed DMC

• 2 other identifiers: RF1AG0478661RF1AG047866-01A1
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 4

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.

Conditions

Alzheimer Disease; Amyloid Beta-Peptides; Risk Assessment; Education; Neuropsychological Tests; Neuroimaging

Outcome Measures

Primary Outcomes (1)

• Change in baseline neuropsychological performance compared to 6 weeks and 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 Outcomes (2)

• Change in baseline measure scores on scales and questionnaires of psychological distress compared to 6 weeks and 6 months post-disclosure.

  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.

  Baseline, 6 weeks post-disclosure, 6-months post-disclosure

Study Arms (2)

Amyloid Brain Imaging Non-Disclosure

ACTIVE COMPARATOR

Subjects will receive their Alzheimer's disease (AD) risk assessment based on age, gender, family history and ancestry.

Behavioral: Alzheimer's Disease Risk Disclosure

Amyloid Brain Imaging Disclosure

EXPERIMENTAL

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

Interventions

Alzheimer's Disease Risk Disclosure BEHAVIORAL

Subjects will learn a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

Amyloid Brain Imaging Non-Disclosure

Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure BEHAVIORAL

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.

Amyloid Brain Imaging Disclosure

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• University of Pennsylvania: collaborator
• University of Michigan: collaborator
• Duke University: collaborator
• Boston University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert C Green, MD, MPH

  Brigham and Women's Hospital

  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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of REVEAL-SCAN

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: May 13, 2020
• Study Completion: April 29, 2021
• Last Updated: April 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)