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

August 17, 2004
July 22, 2009
May 2003
September 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00089882 on ClinicalTrials.gov Archive Site
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Risk Evaluation and Education for Alzheimer's Disease (REVEAL) II
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) II

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.

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.

Observational
Time Perspective: Prospective
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Alzheimer Disease
Procedure: APOE Genetic susceptibility testing
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
360
September 2006
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00089882
IA0057, 2-R01-HG 02213-04, Boston University SOM: H-23380
Not Provided
Robert C. Green, MD, MPH, Boston University
National Institute on Aging (NIA)
National Human Genome Research Institute (NHGRI)
Principal Investigator: Robert C. Green, MD, MPH Boston University School of Medicine, Genetics Program and Alzheimer's Disease Center
National Institute on Aging (NIA)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP