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Sponsored by: |
National Human Genome Research Institute (NHGRI) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00462917 |
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.
Condition | Intervention |
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Alzheimer Disease |
Behavioral: AD Risk Assessment |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Single Blind (Subject), Parallel Assignment, Efficacy Study |
Official Title: | Risk Evaluation and Education for Alzheimer's Disease |
Estimated Enrollment: | 280 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Risk Assessment based on genetic test results
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Behavioral: AD Risk Assessment
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease.
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2: Active Comparator
Risk Assessment based on genetic test results
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Behavioral: AD Risk Assessment
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease.
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
Howard University | |
Washington, District of Columbia, United States, 20059 | |
United States, Massachusetts | |
Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
University of Michigan (currently wait-listing) | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44120 |
Principal Investigator: | Robert Green, MD, MPH | Boston University |
Responsible Party: | Boston University School of Medicine ( Robert C. Green, MD, MPH ) |
Study ID Numbers: | IA0113, HG02213 |
Study First Received: | April 17, 2007 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00462917 |
Health Authority: | United States: Federal Government |
disease /disorder proneness /risk family genetics genetic counseling genetic marker |
genetic polymorphism genetic screening genetic susceptibility |
Delirium, Dementia, Amnestic, Cognitive Disorders Disease Susceptibility Mental Disorders Alzheimer Disease Central Nervous System Diseases Genetic Predisposition to Disease |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |