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Sunday, March 23, 2008

Clinical Trial: Risk Evaluation and Education for Alzheimer's Disease



This study is currently recruiting participants.


Risk Evaluation and Education for Alzheimer's Disease

Official Title

Risk Evaluation and Education for Alzheimer's Disease

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 Status:Recruiting
Enrollment: 280
Start Date:March 2007
Completion Date:March 2010
Gender Both
Ages 18 Years to 85 Years
Accepts Healthy Volunteers: Yes

Study Sponsor National Human Genome Research Institute (NHGRI)

Principal Investigator: Robert Green, MD, MPH, Boston University

Information Provided By National Institute on Aging (NIA)

Contact: Susan Hiraki, MS 617-638-5355
shiraki@bu.edu

Links:

Boston University Alzheimer's Disease Center - REVEAL Study

Alzheimer's Disease Genetics Fact Sheet