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

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ClinicalTrials.gov Identifier: NCT02959489
Recruitment Status : Recruiting
First Posted : November 9, 2016
Last Update Posted : December 20, 2016
Sponsor:
Collaborators:
University of Pennsylvania
University of Michigan
Duke University
Boston University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Robert C. Green, MD, MPH, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Amyloid Beta-Peptides Risk Assessment Education Neuropsychological Tests Neuroimaging Behavioral: Alzheimer's Disease Risk Disclosure Behavioral: Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure Not Applicable

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 (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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN)
Study Start Date : November 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02959489


Contacts
Contact: Sheila Sutti, MS, CGC 617-264-5879 ssutti@bwh.harvard.edu
Contact: Eleanor Steffens, BA 617-264-5889 esteffens@bwh.harvard.edu

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sheila Sutti, MS, CGC    617-264-5879    ssutti@bwh.harvard.edu   
Principal Investigator: Robert C Green, MD, MPH         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lan Le, MPH    734-615-2422    lqle@umich.edu   
Principal Investigator: J. Scott Roberts, PhD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Michelle McCart, BA    919-668-1605    michelle.mccart@duke.edu   
Principal Investigator: Kathleen Welsh-Bohmer, PhD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joseph Harrison, BS    215-662-6093    Joseph.Harrison@uphs.upenn.edu   
Principal Investigator: Jason Karlawish, MD         
Sponsors and Collaborators
Brigham and Women's Hospital
University of Pennsylvania
University of Michigan
Duke University
Boston University
National Institute on Aging (NIA)
Investigators
Principal Investigator: 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

Responsible Party: Robert C. Green, MD, MPH, Principal Investigator of REVEAL-SCAN, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02959489     History of Changes
Other Study ID Numbers: RF1AG047866 ( U.S. NIH Grant/Contract )
1RF1AG047866-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Metabolic Diseases
Amyloidosis
Dementia
Tauopathies
Proteostasis Deficiencies