Alzheimer DiseaseREVEAL-SCANNCT02959489
Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN)
A study testing Alzheimer's Disease Risk Disclosure and Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure in people with Alzheimer Disease and Amyloid Beta-Peptides, run by Brigham and Women's Hospital at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Amyloid Beta-Peptides, Risk Assessment
- What is being tested?
- Alzheimer's Disease Risk Disclosure and Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2016to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Duke University
Durham, North Carolina, 27705
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Amyloid Beta-Peptides, Risk Assessment, Education, Neuropsychological Tests, Neuroimaging
- Being tested
- Alzheimer's Disease Risk Disclosure, Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alzheimer's Disease Risk DisclosureBehavioural
Subjects will learn a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Amyloid Brain Imaging and Alzheimer's Disease Risk DisclosureBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
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.
Measured: Baseline, 6 weeks post-disclosure, 6-months post-disclosure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion13 May 2020
- Study completion29 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Michigan, Duke University, Boston University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Robert C. Green, MD, MPH, Brigham and Women's Hospital
- Investigators
- Robert C Green, MD, MPH, Principal investigator, Brigham and Women's HospitalJason Karlawish, MD, Principal investigator, University of PennsylvaniaJ. Scott Roberts, PhD, Principal investigator, University of MichiganKathleen Welsh-Boomer, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959489
- Sponsor's protocol ID
- RF1AG047866
- Other IDs
- 1RF1AG047866-01A1
- Acronym
- REVEAL-SCAN
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2016
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN)
- ClinicalTrials.gov ID
- NCT02959489
- Acronym / sponsor ID
- REVEAL-SCAN / RF1AG047866
- Conditions
- Alzheimer Disease, Amyloid Beta-Peptides, Risk Assessment, Education, Neuropsychological Tests, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of Michigan, Duke University, Boston University, National Institute on Aging (NIA)
- Study start
- Nov 2016
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 29 Apr 2021 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amyloid Brain Imaging Non-Disclosure | Active comparator | Behavioral: Alzheimer's Disease Risk DisclosureSubjects will receive their Alzheimer's disease (AD) risk assessment based on age, gender, family history and ancestry. |
| Amyloid Brain Imaging Disclosure | Experimental | Behavioral: Amyloid Brain Imaging and Alzheimer's Disease Risk DisclosureSubjects 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. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alzheimer's Disease Risk DisclosureSubjects will learn a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type. | Behavioural | Amyloid Brain Imaging Non-Disclosure |
| Amyloid Brain Imaging and Alzheimer's Disease Risk DisclosureSubjects 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. | Behavioural | Amyloid Brain Imaging Disclosure |
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Green, MD, MPH principal investigator
Brigham and Women's Hospital
Jason Karlawish, MD principal investigator
University of Pennsylvania
J. Scott Roberts, PhD principal investigator
University of Michigan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alzheimer's Disease Risk Disclosure and Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure in people with Alzheimer Disease and Amyloid Beta-Peptides, run by Brigham and Women's Hospital at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.