Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV

Study Overview
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Brief Summary
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This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).

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 which can provide information about a person's chances of developing Alzheimer's disease. Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years. Participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.

Official Title
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Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: APOE genotype and Alzheimer's disease risk disclosure
* Behavioral: Alzheimer's disease risk disclosure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria) Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews. Exclusion Criteria: Individuals with current, untreated anxiety or depression Individuals who do not meet the criteria for amnestic-MCI Individuals who have the diagnosis of dementia or Alzheimer's disease Individuals not fluent in English Individuals who do not have a study partner

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Active Comparator: APOE Genotype Non-Disclosure<br>Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone. | Behavioral: Alzheimer's disease risk disclosure<br>* Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.<br>|
| Experimental: APOE Genotype Disclosure<br>Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype. | Behavioral: APOE genotype and Alzheimer's disease risk disclosure<br>* Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geriatric Depression Scale | A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression. | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | 
| Mini State Trait Anxiety Inventory | Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety. | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Event Scale (IES) | The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event. | 1-3 Days, 6 Weeks and 6 Months Post-disclosure | 
| Psychological Impact of Test Disclosure (IGT-AD) | 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. Higher scores indicate greater distress about the risk assessment. | 6 Weeks and 6 Months Post-disclosure | 
| Recall and Comprehension of Risk Information | Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms (What form of APOE increases risk for Alzheimer's disease?, and What percentage were you given as your 3-year risk of developing Alzheimer's disease?) are summarized here. | 6 Weeks and 6 Months Post-disclosure | 
| Participant Satisfaction | How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better. | 6 Weeks and 6 Months Post-disclosure | 
| User Ratings of Risk Assessment Experience | Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being very negative and 5 being very positive | 6 Weeks and 6 Months Post-disclosure | 
| Health Behavior and Insurance Changes | AD prevention behaviors enacted within the prior two weeks. | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | 
| Insurance and Advance Planning Changes | A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning. | 6 months post-disclosure | 
| Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. | Yes/no response to the question, Since receiving your Alzheimer's disease risk estimate, have you joined any other Alzheimer's disease-related research studies? | 6 weeks and 6 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 (MCI), Alzheimer's disease (AD), APOE, genetics, risk assessment, education, genetic counseling, Mild Cognitive Impairment, So Stated