Risk Evaluation and Education for Alzheimer's Disease

Alzheimer's Disease Clinical Trial

— REVEAL I  

Official title:

Genetic Risk Assessment and Counseling for Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571025
• Other study ID #: IA0126
• Secondary ID: 5R01HG002213
• Status: Completed
• Phase: N/A
• First received: December 7, 2007
• Last updated: July 22, 2009
• Start date: August 2000
• Est. completion date: April 2004

Study information

• Verified date: July 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: April 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Behavioral:
• APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.

Locations

Country	Name	City	State
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Case Western Reserve University	Cleveland	Ohio
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Center for Epidemiological Studies-Depression Scale (CES-D)		baseline, 6 weeks, 6 months, 12 months post-disclosure	Yes
Primary	Beck Anxiety Inventory (BAI)		baseline, 6 weeks, 6 months, 12 months post-disclosure	Yes
Secondary	Impact of Events Scale (IES)		6 weeks, 6 months, 12 months post-disclosure	No
Secondary	Future Attitudes Scale (FAS)		baseline, 6 weeks, 6 months, 12 months post-disclosure	No
Secondary	Positive and Negative Affect Schedule (PANAS)		baseline, 6 weeks, 6 months, 12 months post-disclosure	No