Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01434667 |
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Recruitment Status
: Unknown
Verified July 2013 by Robert C. Green, MD, MPH, Brigham and Women's Hospital.
Recruitment status was: Active, not recruiting
First Posted
: September 15, 2011
Last Update Posted
: August 1, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mild Cognitive Impairment | Behavioral: APOE genotype disclosure and Alzheimer's disease risk disclosure Behavioral: Alzheimer's disease risk disclosure | Not Applicable |
Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene which can provide information about a person's chances of developing Alzheimer's disease.
Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years.
Participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 360 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV |
| Study Start Date : | January 2010 |
| Estimated Primary Completion Date : | June 2014 |
| Estimated Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: APOE Genotype Non-Disclosure |
Behavioral: Alzheimer's disease risk disclosure
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
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| Experimental: APOE Genotype Disclosure |
Behavioral: APOE genotype disclosure and Alzheimer's disease risk disclosure
Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
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- Change in Geriatric Depression Rating Scale [ Time Frame: Change from Baseline at 6 Weeks, 6 Months and 12 Months Post-disclosure ]Validated scale of depression
- Change in Mini-State Trait Anxiety Inventory [ Time Frame: Change from Baseline at 6 Weeks, 6 Months and 12 Months Post-disclosure ]Validated scale of anxiety
- Test-Specific Distress [ Time Frame: 1-3 Days, 6 Weeks, 6 Months and 12 Months Post-disclosure ]Validated scale that assesses two common responses related to a specific stressful life event.
- Psychological Impact of Test Disclosure (IGT-AD) [ Time Frame: 6 Weeks, 6 Months and 12 Months Post-disclosure ]A measure designed to assess the impact of genetic test result disclosure across three domains: distress, uncertainty and positive experiences.
- Recall and Comprehension of Risk Information [ Time Frame: 6 Weeks, 6 Months and 12 Months Post-disclosure ]Several measures to assess participant recall and comprehension of personalized risk information for AD.
- Participant Satisfaction [ Time Frame: Baseline, 6 Weeks, 6 Months and 12 Months Post-disclosure ]How well participants' pre-test expectations are met.
- User Ratings of Risk Assessment Experience [ Time Frame: Baseline ]Subjective ratings of the impact and utility of risk assessment.
- Health Behavior and Insurance Changes [ Time Frame: 6 Weeks, 6 Months and 12 Months Post-disclosure ]Examine behavior changes, advance planning changes, insurance changes, medication changes, enrollment in clinical research.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years to 90 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Individuals with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)
- Individuals who have a close friend, relative or spouse willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.
Exclusion Criteria:
- Individuals with current, untreated anxiety or depression
- Individuals who do not meet the criteria for amnestic-MCI
- Individuals who have the diagnosis of dementia or Alzheimer's disease
- Individuals not fluent in English
- Individuals who do not have a study partner
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): NCT01434667
| United States, District of Columbia | |
| Howard University | |
| Washington, District of Columbia, United States, 20060 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | Robert C Green, MD, MPH | Brigham and Women's Hospital/Harvard Medical School |
Additional Information:
Publications:
| Responsible Party: | Robert C. Green, MD, MPH, Principal Investigator, The REVEAL Study, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01434667 History of Changes |
| Other Study ID Numbers: |
R01HG002213 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 15, 2011 Key Record Dates |
| Last Update Posted: | August 1, 2013 |
| Last Verified: | July 2013 |
Keywords provided by Robert C. Green, MD, MPH, Brigham and Women's Hospital:
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Mild Cognitive Impairment (MCI) Alzheimer's disease (AD) APOE genetics |
risk assessment education genetic counseling Mild Cognitive Impairment, So Stated |
Additional relevant MeSH terms:
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Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |