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Sponsors and Collaborators: |
National Human Genome Research Institute (NHGRI) National Institute on Aging (NIA) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00571025 |
The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.
Condition | Intervention |
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Alzheimer's Disease |
Behavioral: APOE Disclosure |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Genetic Risk Assessment and Counseling for Alzheimer's Disease |
Enrollment: | 301 |
Study Start Date: | August 2000 |
Study Completion Date: | April 2004 |
Arms | Assigned Interventions |
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1: Experimental
AD risk assessment based on family history and APOE genotype
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Behavioral: APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
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2: Active Comparator
AD risk assessment based on family history alone
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Behavioral: APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
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Advances in genetic research have led to an increased number of testing procedures to determine future risk of disease among at-risk individuals. An increasing number of genes are being identified that confer susceptibility for a given disease rather than inevitably causing it. Given that such genes may provide risk information for common diseases (e.g., stroke, depression), there is a growing need to understand how at-risk populations might respond to the option of genetic susceptibility testing. A prominent case in point is Alzheimer's disease (AD).
Participation in this study requires an initial phone call which will elicit some medical and family history information about the participant. A first in-person visit to the clinic will consist of an education session and the administration of some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later, participants will return to have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the experimental arm will receive information on their risk based on their family history and APOE genotype, while those in the active comparator arm will receive information on their risk for developing Alzheimer's disease based on their family history alone. Participants will be followed for 1 year following disclosure of results with 2 additional clinic visits.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Boston University School of Medicine | |
Boston, Massachusetts, United States, 02118 | |
United States, New York | |
Weill Medical College of Cornell University | |
New York, New York, United States, 10021 | |
United States, Ohio | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44120 |
Principal Investigator: | Robert C. Green, MD, MPH | Boston University |
Responsible Party: | Boston University School of Medicine ( Robert C. Green, MD, MPH ) |
Study ID Numbers: | IA0126, 5R01HG002213 |
Study First Received: | December 7, 2007 |
Last Updated: | December 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00571025 |
Health Authority: | United States: Federal Government |
Mild Cognitive Impairment disease/disorder proneness/risk family genetics genetic counseling |
genetic marker genetic polymorphism 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 |