REVEAL III: Risk Evaluation and Education for Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00462917
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.
- Detailed Description
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 that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.
Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
- Aged 18 years to 85 years old
- Unable to visit a study site
- Current untreated depression or anxiety
- Family history of AD diagnosed under age 60
- More than one first-degree relative diagnosed with AD (e.g. Mother and brother)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Center for Epidemiological Studies-Depression Scale (CES-D) 6 weeks, 6 months, and 12 months post-disclosure A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Beck Anxiety Inventory (BAI) 6 weeks, 6 months, 12 months post-disclosure A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
- Secondary Outcome Measures
Name Time Method Impact of Events Scale (IES) 6 weeks, 6 months, 12 months post-disclosure A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.
Trial Locations
- Locations (4)
Howard University
🇺🇸Washington, District of Columbia, United States
Boston University School of Medicine
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Howard University🇺🇸Washington, District of Columbia, United States