Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Overall Status:
Active, not recruiting
Brief Description:
This study will examine the impact of receiving a genetic risk assessment for Alzheimer's disease among individuals with mild cognitive impairment (MCI).
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
55 Years | 90 Years | Both | No |
Inclusion Criteria:
- Amnestic mild cognitive impairment (as defined by the Petersen criteria)
- Fluent in English
- Close friend, relative, or spouse willing to attend each study visit with the participant and complete surveys and interviews
Exclusion Criteria:
- Current untreated anxiety or depression
- Diagnosis of dementia or Alzheimer's disease
Detailed Description:
Apolipoprotein E (APOE) is a gene that can provide information about a person's chances of developing Alzheimer's disease. Some people with a diagnosis of MCI are curious to learn more about their chance of developing Alzheimer's. We will examine the psychological and behavioral impact of learning genetic information pertaining to the risk of progressing from MCI to Alzheimer's within 3 years.
This study requires participation in an education session, knowledge and attitudinal surveys, and tests to assess memory and thinking skills. Participants with MCI will have their blood drawn for genetic testing and be randomized to one of two groups. Those in the intervention arm will receive a 3-year risk estimate for the chance of progressing to dementia of the Alzheimer's type with the APOE gene test result. Those in the comparison arm will receive a 3-year risk estimate for the chance of progressing to dementia of the Alzheimer's type without the APOE gene test result. The latter group 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 one additional clinic visit and one additional phone interview.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 38.9178427, -77.0218255 | Washington | District of Columbia | 20060 | Name: Phone: | ||
Geolocation is 42.3053253, -83.6694169 | Ann Arbor | Michigan | 48109 | Name: Phone: | ||
Geolocation is 39.9583587, -75.1953934 | Philadelphia | Pennsylvania | 19104 | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Brigham and Women's Hospital |
Collaborator Sponsor:
| Agency |
|---|
National Human Genome Research Institute (NHGRI) |
University of Michigan |
University of Pennsylvania |
Howard University |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Robert C. Green, MD, MPH | Principal Investigator | Brigham and Women's Hospital/Harvard Medical School |
Study Contact:
| Name | Phone | |
|---|---|---|
Leo B. Waterston | 617-264-5879 |
Locations
ClinicalTrials.gov ID
NCT01434667 (follow link to view full record on ct.gov in new window)
Official Title:
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Study Start Date:
January 2010
Study End Date:
June 2013
Disease Stage:
Early
Enrollment:
360
Trial References:
