Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
NCT ID: NCT01434667
Last Updated: 2018-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
146 participants
INTERVENTIONAL
2010-01-31
2014-07-31
Brief Summary
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Detailed Description
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Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years.
Participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
Alzheimer's disease risk disclosure
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
APOE Genotype Disclosure
Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.
APOE genotype and Alzheimer's disease risk disclosure
Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Interventions
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APOE genotype and Alzheimer's disease risk disclosure
Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Alzheimer's disease risk disclosure
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Eligibility Criteria
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Inclusion Criteria
* Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.
Exclusion Criteria
* Individuals who do not meet the criteria for amnestic-MCI
* Individuals who have the diagnosis of dementia or Alzheimer's disease
* Individuals not fluent in English
* Individuals who do not have a study partner
18 Years
ALL
No
Sponsors
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National Human Genome Research Institute (NHGRI)
NIH
University of Michigan
OTHER
University of Pennsylvania
OTHER
Howard University
OTHER
Brigham and Women's Hospital
OTHER
Responsible Party
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Robert C. Green, MD, MPH
Principal Investigator, The REVEAL Study
Principal Investigators
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Robert C Green, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital/Harvard Medical School
Locations
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Howard University
Washington D.C., District of Columbia, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Roberts JS, Karlawish JH, Uhlmann WR, Petersen RC, Green RC. Mild cognitive impairment in clinical care: a survey of American Academy of Neurology members. Neurology. 2010 Aug 3;75(5):425-31. doi: 10.1212/WNL.0b013e3181eb5872.
Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18.
Guan Y, Roter DL, Wolff JL, Gitlin LN, Christensen KD, Roberts JS, Green RC, Erby LH. The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ Couns. 2018 May;101(5):817-823. doi: 10.1016/j.pec.2017.11.019. Epub 2017 Nov 27.
Guan Y, Roter DL, Erby LH, Wolff JL, Gitlin LN, Roberts JS, Green RC, Christensen KD. Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns. 2017 May;100(5):927-935. doi: 10.1016/j.pec.2016.12.005. Epub 2016 Dec 14.
Related Links
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Alzheimer's Association - Educational Materials on Mild Cognitive Impairment
Alzheimer's Association - Educational Materials on Risk Factors
REVEAL Study overview
Other Identifiers
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