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

September 25, 2018 updated by: Robert C. Green, MD, MPH, Brigham and Women's Hospital

Risk Evaluation and Education for Alzheimer's Disease

The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.

Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.

Study Type

Interventional

Enrollment (Actual)

290

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
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard University
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18 years to 85 years old

Exclusion Criteria:

  • Unable to visit a study site
  • Current untreated depression or anxiety
  • Family history of AD diagnosed under age 60
  • More than one first-degree relative diagnosed with AD (e.g. Mother and brother)

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: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pleiotropic info, in-person disclosure
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Behavioral: Pleiotropic info, in-person disclosure

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.

Genetic counselors communicate results to participants during an in-person disclosure session.
Experimental: AD-only info, phone disclosure
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
Behavioral: AD-only info, phone disclosure

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.

Genetic counselors communicate results to participants during an in-person disclosure session.
Experimental: Pleiotropic info, phone disclosure
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Behavioral: Pleiotropic info, phone disclosure

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.

Genetic counselors communicate results to participants during a telephone disclosure session.
Active Comparator: AD-only info, in-person disclosure
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
Behavioral: AD-only info, in-person disclosure

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.

Genetic counselors communicate results to participants during an in-person disclosure session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Center for Epidemiological Studies-Depression Scale (CES-D)
Time Frame: 6 weeks, 6 months, and 12 months post-disclosure
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
6 weeks, 6 months, and 12 months post-disclosure
Beck Anxiety Inventory (BAI)
Time Frame: 6 weeks, 6 months, 12 months post-disclosure
A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
6 weeks, 6 months, 12 months post-disclosure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Events Scale (IES)
Time Frame: 6 weeks, 6 months, 12 months post-disclosure
A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress.
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

Brigham and Women's Hospital

Collaborators

National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Robert Green, MD, MPH, Brigham and Women's Hospital

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

Helpful Links

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

March 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

April 17, 2007

First Submitted That Met QC Criteria

April 17, 2007

First Posted (Estimate)

April 19, 2007

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0113
  • R01HG002213 (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.

Clinical Trials on Alzheimer Disease

Clinical Trials on Pleiotropic info, in-person disclosure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Netherlands

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe