Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01434667|
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : October 23, 2018
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mild Cognitive Impairment||Behavioral: APOE genotype and Alzheimer's disease risk disclosure Behavioral: Alzheimer's disease risk disclosure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Active Comparator: APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
Behavioral: Alzheimer's disease risk disclosure
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Experimental: APOE Genotype Disclosure
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
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.
- Geriatric Depression Scale [ Time Frame: 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 [ Time Frame: 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.
- Impact of Event Scale (IES) [ Time Frame: 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) [ Time Frame: 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.
- Recall and Comprehension of Risk Information [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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"
- Health Behavior and Insurance Changes [ Time Frame: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure ]AD prevention behaviors enacted within the prior two weeks.
- Insurance and Advance Planning Changes [ Time Frame: 6 months post-disclosure ]A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
- Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. [ Time Frame: 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?"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434667
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20060|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Robert C Green, MD, MPH||Brigham and Women's Hospital/Harvard Medical School|