Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Alzheimer's disease risk disclosureBehavioral: APOE genotype and Alzheimer's disease risk disclosure
- Registration Number
- NCT01434667
- Lead Sponsor
- Brigham and Women's Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description APOE Genotype Non-Disclosure Alzheimer's disease risk disclosure Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone. APOE Genotype Disclosure APOE genotype and Alzheimer's disease risk disclosure Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.
- Primary Outcome Measures
Name Time Method Geriatric Depression Scale Baseline, 6 weeks post-disclosure, and 6 months post-disclosure A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.
Mini State Trait Anxiety Inventory Baseline, 6 weeks post-disclosure, and 6 months post-disclosure 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.
- Secondary Outcome Measures
Name Time Method Impact of Event Scale (IES) 1-3 Days, 6 Weeks and 6 Months Post-disclosure 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.
Psychological Impact of Test Disclosure (IGT-AD) 6 Weeks and 6 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. Higher scores indicate greater distress about the risk assessment.
Health Behavior and Insurance Changes Baseline, 6 weeks post-disclosure, and 6 months post-disclosure AD prevention behaviors enacted within the prior two weeks.
Recall and Comprehension of Risk Information 6 Weeks and 6 Months Post-disclosure 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.
Participant Satisfaction 6 Weeks and 6 Months Post-disclosure 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.
User Ratings of Risk Assessment Experience 6 Weeks and 6 Months Post-disclosure 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"
Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. 6 weeks and 6 months post-disclosure 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?"
Insurance and Advance Planning Changes 6 months post-disclosure A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
Trial Locations
- Locations (3)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Howard University
🇺🇸Washington, District of Columbia, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States