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

Mass General Brigham

Status: Completed

Conditions: Alzheimer Disease

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00462917

R01HG002213 (U.S. NIH Grant/Contract)

IA0113

Details and patient eligibility

About

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

Full 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.

Enrollment: 290 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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290 participants in 4 patient groups

Pleiotropic info, in-person disclosure

Experimental group

Description:

Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment

Treatment:

Behavioral: Pleiotropic info, in-person disclosure

AD-only info, phone disclosure

Experimental group

Description:

Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment

Treatment:

Behavioral: AD-only info, phone disclosure

Pleiotropic info, phone disclosure

Experimental group

Description:

Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment

Treatment:

Behavioral: Pleiotropic info, phone disclosure

AD-only info, in-person disclosure

Active Comparator group

Description:

Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment

Treatment:

Behavioral: AD-only info, in-person disclosure