Risk Evaluation and Education for Alzheimer's Disease (REVEAL) II
|ClinicalTrials.gov Identifier: NCT00089882|
Recruitment Status : Completed
First Posted : August 18, 2004
Last Update Posted : July 23, 2009
|Condition or disease||Intervention/treatment|
|Alzheimer Disease||Procedure: APOE Genetic susceptibility testing|
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.
|Study Type :||Observational|
|Estimated Enrollment :||360 participants|
|Official Title:||Risk Evaluation and Education for Alzheimer's Disease (REVEAL) II|
|Study Start Date :||May 2003|
|Primary Completion Date :||September 2006|
|Study Completion Date :||September 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089882
|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|
|Principal Investigator:||Robert C. Green, MD, MPH||Boston University School of Medicine, Genetics Program and Alzheimer's Disease Center|