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Risk Evaluation and Education for Alzheimer's Disease

Genetic Risk Assessment and Counseling for Alzheimer's Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00571025
Acronym
REVEAL I
Enrollment
301
Registered
2007-12-11
Start date
2000-08-31
Completion date
2004-04-30
Last updated
2009-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Mild Cognitive Impairment, disease/disorder proneness/risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic susceptibility

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.

Interventions

BEHAVIORALAPOE Disclosure

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
National Human Genome Research Institute (NHGRI)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026