Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
301 participants
INTERVENTIONAL
2000-08-31
2004-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1
AD risk assessment based on family history and APOE genotype
APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
2
AD risk assessment based on family history alone
APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
Interventions
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APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
Exclusion Criteria
* Current untreated depression
18 Years
85 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
National Human Genome Research Institute (NHGRI)
NIH
Responsible Party
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Boston University School of Medicine
Principal Investigators
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Robert C. Green, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Boston University
Locations
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Boston University School of Medicine
Boston, Massachusetts, United States
Weill Medical College of Cornell University
New York, New York, United States
Case Western Reserve University
Cleveland, Ohio, United States
Countries
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References
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Farrer LA, Cupples LA, Haines JL, Hyman B, Kukull WA, Mayeux R, Myers RH, Pericak-Vance MA, Risch N, van Duijn CM. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease. A meta-analysis. APOE and Alzheimer Disease Meta Analysis Consortium. JAMA. 1997 Oct 22-29;278(16):1349-56.
Green RC, Clarke VC, Thompson NJ, Woodard JL, Letz R. Early detection of Alzheimer disease: methods, markers, and misgivings. Alzheimer Dis Assoc Disord. 1997;11 Suppl 5:S1-5; discussion S37-9. doi: 10.1016/s0197-4580(96)80334-4.
Green RC, Cupples LA, Go R, Benke KS, Edeki T, Griffith PA, Williams M, Hipps Y, Graff-Radford N, Bachman D, Farrer LA; MIRAGE Study Group. Risk of dementia among white and African American relatives of patients with Alzheimer disease. JAMA. 2002 Jan 16;287(3):329-36. doi: 10.1001/jama.287.3.329.
Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med. 2009 Jul 16;361(3):245-54. doi: 10.1056/NEJMoa0809578.
Other Identifiers
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IA0126
Identifier Type: -
Identifier Source: org_study_id
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