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 determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.

Detailed Description
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Advances in genetic research have led to an increased number of testing procedures to determine future risk of disease among at-risk individuals. An increasing number of genes are being identified that confer susceptibility for a given disease rather than inevitably causing it. Given that such genes may provide risk information for common diseases (e.g., stroke, depression), there is a growing need to understand how at-risk populations might respond to the option of genetic susceptibility testing. A prominent case in point is Alzheimer's disease (AD). Participation in this study requires an initial phone call which will elicit some medical and family history information about the participant. A first in-person visit to the clinic will consist of an education session and the administration of some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later, participants will return to have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the experimental arm will receive information on their risk based on their family history and APOE genotype, while those in the active comparator arm will receive information on their risk for developing Alzheimer's disease based on their family history alone. Participants will be followed for 1 year following disclosure of results with 2 additional clinic visits.

Official Title
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Genetic Risk Assessment and Counseling for Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Behavioral: APOE Disclosure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease 18 years or older Exclusion Criteria: Current dementia Current untreated depression

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AD risk assessment based on family history and APOE genotype | Behavioral: APOE Disclosure<br>* Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.<br>|
| Active Comparator: 2<br>AD risk assessment based on family history alone | Behavioral: APOE Disclosure<br>* Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.<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) |  | baseline, 6 weeks, 6 months, 12 months post-disclosure | 
| Beck Anxiety Inventory (BAI) |  | baseline, 6 weeks, 6 months, 12 months post-disclosure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Events Scale (IES) |  | 6 weeks, 6 months, 12 months post-disclosure | 
| Future Attitudes Scale (FAS) |  | baseline, 6 weeks, 6 months, 12 months post-disclosure | 
| Positive and Negative Affect Schedule (PANAS) |  | baseline, 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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Mild Cognitive Impairment, disease/disorder proneness/risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic susceptibility