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

Not Applicable

Completed

Conditions: Alzheimer Disease

Interventions: Behavioral: AD-only info, in-person disclosure
Behavioral: Pleiotropic info, in-person disclosure
Behavioral: AD-only info, phone disclosure
Behavioral: Pleiotropic info, phone disclosure

Registration Number: NCT00462917

Lead Sponsor: Brigham and Women's Hospital

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 290

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 & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
AD-only info, in-person disclosure	AD-only info, in-person disclosure	Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure	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
AD-only info, phone disclosure	AD-only info, phone disclosure	Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure	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

Primary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies-Depression Scale (CES-D)	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.
Beck Anxiety Inventory (BAI)	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.

Secondary Outcome Measures

Name	Time	Method
Impact of Events Scale (IES)	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.

Trial Locations

Locations (4): Howard University
🇺🇸
Washington, District of Columbia, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Boston University School of Medicine
🇺🇸
Boston, Massachusetts, United States
Case Western Reserve University
🇺🇸
Cleveland, Ohio, United States