Risk Evaluation and Education for Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Behavioral: APOE Disclosure

• Registration Number: NCT00571025
• Lead Sponsor: National Human Genome Research Institute (NHGRI)

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.

Study Timeline

• Study Start: 2000-08
• Study Completion: 2004-04
• Study First Submitted: 2007-12-07
• Study First Submitted QC: 2007-12-07
• Study First Posted: 2007-12-11
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-22
• Last Update Posted: 2009-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	APOE Disclosure	AD risk assessment based on family history and APOE genotype
2	APOE Disclosure	AD risk assessment based on family history alone

Primary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies-Depression Scale (CES-D)	baseline, 6 weeks, 6 months, 12 months post-disclosure
Beck Anxiety Inventory (BAI)	baseline, 6 weeks, 6 months, 12 months post-disclosure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Weill Medical College of Cornell University; 🇺🇸 New York, New York, United States

Boston University School of Medicine; 🇺🇸 Boston, Massachusetts, United States