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Clinical Trials/NCT00571025
NCT00571025
Completed
Not Applicable

Genetic Risk Assessment and Counseling for Alzheimer's Disease

National Human Genome Research Institute (NHGRI)3 sites in 1 country301 target enrollmentAugust 2000

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
National Human Genome Research Institute (NHGRI)
Enrollment
301
Locations
3
Primary Endpoint
Center for Epidemiological Studies-Depression Scale (CES-D)
Status
Completed
Last Updated
16 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
August 2000
End Date
April 2004
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Center for Epidemiological Studies-Depression Scale (CES-D)

Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure

Beck Anxiety Inventory (BAI)

Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure

Secondary Outcomes

  • Impact of Events Scale (IES)(6 weeks, 6 months, 12 months post-disclosure)
  • Future Attitudes Scale (FAS)(baseline, 6 weeks, 6 months, 12 months post-disclosure)
  • Positive and Negative Affect Schedule (PANAS)(baseline, 6 weeks, 6 months, 12 months post-disclosure)

Study Sites (3)

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