The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
290
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during an in-person disclosure session.
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session.
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during a telephone disclosure session.
Howard University
Washington D.C., 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
Center for Epidemiological Studies-Depression Scale (CES-D)
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Time frame: 6 weeks, 6 months, and 12 months post-disclosure
Beck Anxiety Inventory (BAI)
A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
Time frame: 6 weeks, 6 months, 12 months post-disclosure
Impact of Events Scale (IES)
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.
Time frame: 6 weeks, 6 months, 12 months post-disclosure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session.