Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 4 for:    Risk Evaluation and Education for Alzheimer's disease REVEAL
Previous Study | Return to List | Next Study

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert C. Green, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00462917
First received: April 17, 2007
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Alzheimer Disease
Behavioral: Pleiotropic info, in-person disclosure
Behavioral: AD-only info, in-person disclosure
Behavioral: Pleiotropic info, phone disclosure
Behavioral: AD-only info, phone disclosure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Risk Evaluation and Education for Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Center for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: 6 weeks, 6 months, and 12 months post-disclosure ] [ Designated as safety issue: Yes ]
    A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: Yes ]
    A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.


Secondary Outcome Measures:
  • Impact of Events Scale (IES) [ Time Frame: 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]
    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.


Enrollment: 290
Study Start Date: March 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462917

Locations
United States, District of Columbia
Howard University
Washington, District of Columbia, United States, 20059
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44120
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Robert Green, MD, MPH Boston University
  More Information

Additional Information:
Publications:
Responsible Party: Robert C. Green, MD, MPH, Associate Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00462917     History of Changes
Other Study ID Numbers: IA0113, R01HG002213
Study First Received: April 17, 2007
Results First Received: August 21, 2014
Last Updated: September 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
disease /disorder proneness /risk
family genetics
genetic counseling
genetic marker
genetic polymorphism
genetic screening
genetic susceptibility

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 19, 2014