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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Risk Evaluation and Education for Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Behavioral: Pleiotropic info, in-person disclosure
* Behavioral: AD-only info, in-person disclosure
* Behavioral: Pleiotropic info, phone disclosure
* Behavioral: AD-only info, phone disclosure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pleiotropic info, in-person disclosure<br>Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment | Behavioral: Pleiotropic info, in-person disclosure<br>* Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during an in-person disclosure session.<br>|
| Experimental: AD-only info, phone disclosure<br>Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment | Behavioral: AD-only info, phone disclosure<br>* Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session.<br>|
| Experimental: Pleiotropic info, phone disclosure<br>Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment | Behavioral: Pleiotropic info, phone disclosure<br>* Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during a telephone disclosure session.<br>|
| Active Comparator: AD-only info, in-person disclosure<br>Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment | Behavioral: AD-only info, in-person disclosure<br>* Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Center for Epidemiological Studies-Depression Scale (CES-D) | A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression. | 6 weeks, 6 months, and 12 months post-disclosure | 
| Beck Anxiety Inventory (BAI) | A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety. | 6 weeks, 6 months, 12 months post-disclosure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Events Scale (IES) | 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. | 6 weeks, 6 months, 12 months post-disclosure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disease /disorder proneness /risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic screening, genetic susceptibility