Risk Evaluation and Education for Alzheimer's Disease (REVEAL I)

July 22, 2009 updated by: National Human Genome Research Institute (NHGRI)

Genetic Risk Assessment and Counseling for Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

301

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • Ohio
      • Cleveland, Ohio, United States, 44120
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
AD risk assessment based on family history and APOE genotype
Behavioral: APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
Active Comparator: 2
AD risk assessment based on family history alone
Behavioral: APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Human Genome Research Institute (NHGRI)

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Robert C. Green, MD, MPH, Boston University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 7, 2007

First Posted (Estimate)

December 11, 2007

Study Record Updates

Last Update Posted (Estimate)

July 23, 2009

Last Update Submitted That Met QC Criteria

July 22, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0126
  • 5R01HG002213 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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