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
|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|
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|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Sheila Sutti, MS, CGCemail@example.com|
|Contact: Eleanor Steffens, BAfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Sheila Sutti, MS, CGC 617-264-5879 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: J. Scott Roberts, PhD|
|United States, North Carolina|
|Durham, North Carolina, United States, 27705|
|Contact: Michelle McCart, BA 919-668-1605 email@example.com|
|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|
|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|