- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571025
Risk Evaluation and Education for Alzheimer's Disease (REVEAL I)
Genetic Risk Assessment and Counseling for Alzheimer's Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston University School of Medicine
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New York
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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Ohio
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Cleveland, Ohio, United States, 44120
- Case Western Reserve University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
- 18 years or older
Exclusion Criteria:
- Current dementia
- Current untreated depression
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
AD risk assessment based on family history and APOE genotype
|
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
|
Active Comparator: 2
AD risk assessment based on family history alone
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Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Center for Epidemiological Studies-Depression Scale (CES-D)
Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
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baseline, 6 weeks, 6 months, 12 months post-disclosure
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Beck Anxiety Inventory (BAI)
Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
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baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Impact of Events Scale (IES)
Time Frame: 6 weeks, 6 months, 12 months post-disclosure
|
6 weeks, 6 months, 12 months post-disclosure
|
Future Attitudes Scale (FAS)
Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
|
baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Positive and Negative Affect Schedule (PANAS)
Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
|
baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert C. Green, MD, MPH, Boston University
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IA0126
- 5R01HG002213 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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