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NIH Sep 30, 1999 | R01
Risk Evaluation and Education for Alzheimer's Disease (II)
Institution: Boston University Medical Campus
FOA Number: N/A
Abstract
The Risk Evaluation and Education for Alzheimer's Disease (REVEAL) Study is an ongoing, multi-site research project that is designed to evaluate the psychological and behavioral impact of genetic risk assessment with disclosure of APOE, a susceptibility polymorphism for Alzheimer's disease. In the first funding cycle of the REVEAL Study, we developed a novel risk assessment methodology and conducted a randomized clinical trial in which 162 first degree relatives of patients with AD received genetic risk assessment with or without APOE disclosure. The results of this trial suggested that genotype information could be disclosed safely with a highly structured protocol. In the (current) funding cycle of the REVEAL Study, we adjusted our risk curves to incorporate data on African Americans, and we have enrolled 297 subjects into a second randomized trial to examine the impact of genetic risk assessment with a brief, more clinically feasible protocol in comparison to a more conventional genetic counseling protocol.
Preliminary results suggest that the brief protocol is as safe and effective in educating participants as the conventional protocol, so it will be used exclusively in the next phase of our research. In the next funding cycle of the REVEAL Study we propose to combine genotype and phenotype information, creating new risk estimates that incorporate the presence or absence of mild cognitive impairment (MCI), an amnestic condition which increases the probability of developing AD. Because APOE also increases the risk of cardiovascular disease, we will also study disclosure of genetic pleiotropy by enrolling 256 subjects, including 60 MCI subjects, into a new randomized clinical trial that compares the impact of providing risk information on two diseases to providing risk information on just one. We will add outcome measures that explore themes of race and social identity among participants volunteering for genetic risk assessment.
We will also re-examine participants from the first two funding cycles to assess the long-term impact of genetic risk assessment and disclosure for AD up to 10 years following disclosure.
This study will have an impact on public health by informing policy makers and clinicians about safe and effective ways to integrate genetic discoveries into the practice of medicine.
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FUNDING AGENCY:
Funder:
NIHInstitute:
NATIONAL HUMAN GENOME RESEARCH INSTITUTEFunding Type:
R01Project Number:
R01HG002213Start Date:
Sep 30, 1999End Date:
Apr 30, 2009PROJECT TERMS:
Affect, African American, Age, Alzheimer's Disease, Alzheimer's disease risk, Anxiety, Apolipoprotein E, base, Behavioral, Cardiovascular Diseases, cardiovascular disorder risk, cardiovascular risk factor, Clinical, Clinical Trials, Communication, condition, Data, Data Set, design, Development, Disclosure, Disease, Education, education evaluation, Elderly, Enrollment, Family history of, First Degree Relative, Funding, Gender, Genetic, Genetic Counseling, Genetic Polymorphism, Genetic Predisposition to Disease, genetic risk assessment, genotype, Health behavior, instrument, insurance, Link, Measures, Medicine, Methodology, mild neurocognitive impairment, Multi-Institutional Clinical Trial, novel, Outcome, Outcome Measure, Participant, Patients, Persons, Phase, Phenotype, pleiotropism, Policy Maker, Predisposition, Probability, programs, Protocols documentation, psychologic, Public Health, Race, Randomized, Randomized Clinical Trials, Randomized Controlled Clinical Trials, Randomized Controlled Trials, Recruitment Activity, Research, Research Personnel, Research Project Grants, Risk, Risk Assessment, Risk Estimate, Risk Marker, Scientist, Screening procedure, Site, social, Social Identification, sound, Structure, TNFRSF5 gene, trial comparing, Universities, volunteer