REVEAL III: Risk Evaluation and Education for Alzheimer's Disease
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.
| Condition | Intervention |
|---|---|
|
Alzheimer Disease |
Behavioral: AD Risk Assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Risk Evaluation and Education for Alzheimer's Disease |
- Center for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: Yes ]
- Beck Anxiety Inventory (BAI) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: Yes ]
- Impact of Events Scale (IES) [ Time Frame: 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]
- Future Attitudes Scale (FAS) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]
- Positive and Negative Affect Schedule (PANAS) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 280 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Risk Assessment based on genetic test results
|
Behavioral: AD Risk Assessment
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease.
|
|
Active Comparator: 2
Risk Assessment based on genetic test results
|
Behavioral: AD Risk Assessment
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease.
|
Detailed Description:
Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.
Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged 18 years to 85 years old
Exclusion Criteria:
- Unable to visit a study site
- Current untreated depression or anxiety
- Family history of AD diagnosed under age 60
- More than one first-degree relative diagnosed with AD (e.g. Mother and brother)
Contacts and Locations| United States, District of Columbia | |
| Howard University | |
| Washington, District of Columbia, United States, 20059 | |
| United States, Massachusetts | |
| Boston University School of Medicine | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| University of Michigan (currently wait-listing) | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Ohio | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44120 | |
| Principal Investigator: | Robert Green, MD, MPH | Boston University |
More Information
Publications:
| Responsible Party: | Robert C. Green, MD, MPH, Boston University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00462917 History of Changes |
| Other Study ID Numbers: | IA0113, HG02213 |
| Study First Received: | April 17, 2007 |
| Last Updated: | July 22, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute on Aging (NIA):
|
disease /disorder proneness /risk family genetics genetic counseling genetic marker |
genetic polymorphism genetic screening genetic susceptibility |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013