Risk Evaluation and Education for Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 290
- Locations
- 4
- Primary Endpoint
- Center for Epidemiological Studies-Depression Scale (CES-D)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18 years to 85 years old
Exclusion Criteria
- •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)
Arms & Interventions
Pleiotropic info, in-person disclosure
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Intervention: Pleiotropic info, in-person disclosure (Behavioral)
AD-only info, phone disclosure
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
Intervention: AD-only info, phone disclosure (Behavioral)
Pleiotropic info, phone disclosure
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Intervention: Pleiotropic info, phone disclosure (Behavioral)
AD-only info, in-person disclosure
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
Intervention: AD-only info, in-person disclosure (Behavioral)
Outcomes
Primary Outcomes
Center for Epidemiological Studies-Depression Scale (CES-D)
Time Frame: 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)
Time Frame: 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 Outcomes
- Impact of Events Scale (IES)(6 weeks, 6 months, 12 months post-disclosure)
Investigators
Robert C. Green, MD, MPH
Associate Professor of Medicine
Brigham and Women's Hospital