Trial record 3 of 3 for:    REVEAL ApoE

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00089882
First received: August 17, 2004
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

The REVEAL II study provides healthy adult children and siblings of Alzheimer's disease patients with genetic testing and information about their own chances of developing the disease. The study will compare a condensed education and counseling program to the current more extensive program.


Condition Intervention
Alzheimer Disease
Procedure: APOE Genetic susceptibility testing

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Risk Evaluation and Education for Alzheimer's Disease (REVEAL) II

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 360
Study Start Date: May 2003
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Alzheimer's disease (AD) is a common, progressive disease affecting memory and cognition. Apolipoprotein E (APOE) has been identified as a genetic factor that may increase the risk of developing Alzheimer's disease (AD). While several consensus statements have advised against the clinical use of APOE genotyping, each of these called for research to evaluate the impact of susceptibility genotyping and to explore the process of communicating about risk issues. The REVEAL I Study was funded in 1999 to enroll adult children of patients with AD to determine who would choose to obtain APOE genotyping, to devise an education and counseling protocol for the disclosure of APOE genotyping, and to study the impact of disclosing this information. The REVEAL I study demonstrated that Alzheimer's disease risk assessments with APOE genotyping can be given to relatives of people with Alzheimer's disease without causing severe adverse psychological or behavioral effects.

The REVEAL II study will examine whether receiving risk assessment and APOE genotyping disclosure through a Condensed Education and Counseling Protocol is as safe and as effective as receiving such information through our current Extended Protocol. This study will also examine whether there are any differences among groups who receive disclosure of APOE results and risk assessment by different provider types, such as a physician or a genetic counselor. At least one-third of the participants in REVEAL II will be African American, in order to explore how racial identity affects the desire to obtain genetic risk assessment and the impact of receiving it.

Individuals who have a parent or sibling affected by Alzheimer's disease may enter the study either by self-referral to the study coordinator or by recruitment. Participants will have a scheduled phone interview during which demographic information, their relative's medical history, attitudes toward genetic testing and risk assessment for Alzheimer's disease, and interest in going on to the next step of the study will be assessed. During the second step of the study, participants will be randomly assigned to one of three study arms. Participants in the control arm of the study will be given the full educational and counseling protocol as was originally developed in the first funding period of this study. All participants will have the opportunity to continue with the study and have their blood drawn for genotype analysis and risk assessment. Follow-up sessions will be provided with psychometric measures and questionnaires.

Participants will be seen by the genetic counselor for two follow-up appointments, six weeks and six months after disclosure of risk information. A final 12 month follow-up questionnaire will be completed by mail and will be followed by a phone call from the genetic counselor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult children or siblings of people with Alzheimer's disease.

Exclusion Criteria:

  • Adult children or siblings of people with Alzheimer's disease who are unable to visit a study site.
  • Persons with currently untreated depression, anxiety or severe mood disturbances.
  • Persons with cognitive deficits.
  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: NCT00089882

Locations
United States, District of Columbia
Howard University College of Medicine, National Human Genome Center
Washington, District of Columbia, United States, 20059
United States, Massachusetts
Boston University School of Medicine, Alzheimer's Disease Center
Boston, Massachusetts, United States, 02118
United States, New York
Weill Medical College of Cornell University, Memory Disorders Program
New York, New York, United States, 10021
United States, Ohio
Case Western Reserve University, Memory and Aging Center
Cleveland, Ohio, United States, 44120
Sponsors and Collaborators
Investigators
Principal Investigator: Robert C. Green, MD, MPH Boston University School of Medicine, Genetics Program and Alzheimer's Disease Center
  More Information

Publications:
Responsible Party: Robert C. Green, MD, MPH, Boston University
ClinicalTrials.gov Identifier: NCT00089882     History of Changes
Other Study ID Numbers: IA0057, 2-R01-HG 02213-04, Boston University SOM: H-23380
Study First Received: August 17, 2004
Last Updated: July 22, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
Apolipoproteins E (APOE)
Genetic susceptibility testing

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

ClinicalTrials.gov processed this record on July 24, 2014