REVEAL III: Risk Evaluation and Education for Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

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.
    

Intervention name(s): Pleiotropic info, in-person disclosure; AD-only info, in-person disclosure; Pleiotropic info, phone disclosure; AD-only info, phone disclosure
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: disease /disorder proneness /risk; family genetics; genetic counseling; genetic marker; genetic polymorphism; genetic screening; genetic susceptibility