An interventional study of APOE genotype and Alzheimer's disease risk disclosure and Alzheimer's disease risk disclosure in Mild Cognitive Impairment, sponsored by Brigham and Women's Hospital. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Health services research
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).
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 146 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
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.
Time frame: 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.
Time frame: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
Time frame: 6 Weeks and 6 Months Post-disclosure
Health Behavior and Insurance Changes
AD prevention behaviors enacted within the prior two weeks.
Time frame: 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.
Time frame: 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?"
Time frame: 6 weeks and 6 months post-disclosure
| Milestone | Apolipoprotein E (APOE) Genotype Non-Disclosure | Apolipoprotein E (APOE) Genotype Disclosure |
|---|---|---|
| Started | 39 | 75 |
| Completed | 34 | 65 |
| Not completed | 5 | 10 |
| Withdrew: Lost to follow-up | 5 | 10 |
A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| Baseline | 2.6 ± 2.6 | 2.1 ± 2.0 |
| 6 Weeks Post-Disclosure | 2.8 ± 2.7 | 1.9 ± 1.6 |
| 6 Months Post-Disclosure | 2.1 ± 2.2 | 2.0 ± 2.1 |
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.
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| Baseline | 36.3 ± 12.0 | 36.5 ± 10.9 |
| 6 Weeks Post-Disclosure | 39.0 ± 13.6 | 36.6 ± 11.8 |
| 6 Months Post-Disclosure | 36.2 ± 12.3 | 36.2 ± 13.4 |
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.
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| 1-3 Days Post-Disclosure | 8.2 ± 8.7 | 8.1 ± 9.4 |
| 6 Weeks Post-Disclosure | 13.1 ± 11.4 | 11.5 ± 12.6 |
| 6 Months Post-Disclosure | 12.5 ± 11.9 | 12.4 ± 12.0 |
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.
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| 6 Weeks Post-Disclosure | 24.7 ± 10.0 | 19.5 ± 11.5 |
| 6 Months Post-Disclosure | 24.1 ± 10.8 | 20.3 ± 11.2 |
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.
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| 6 Weeks Post-Disclosure | 0.8 ± 0.7 | 1.2 ± 0.8 |
| 6 Months Post-Disclosure | 1.0 ± 0.7 | 1.2 ± 0.7 |
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.
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| Information: 6 Weeks Post-Disclosure | 6.0 ± 1.1 | 6.1 ± 1.2 |
| Explanation: 6 Weeks Post-Disclosure | 5.9 ± 1.2 | 6.2 ± 1.2 |
| Reassurance: 6 Weeks Post-Disclosure | 5.5 ± 1.5 | 6.0 ± 1.3 |
| Advice: 6 Weeks Post-Disclosure | 5.6 ± 1.4 | 5.4 ± 1.7 |
| Help in decision making: 6 Weeks Post-Disclosure | 5.2 ± 1.7 | 5.3 ± 1.6 |
| Information: 6 Months Post-Disclosure | 5.6 ± 1.4 | 6.1 ± 1.2 |
| Explanation: 6 Months Post-Disclosure | 5.7 ± 1.3 | 6.2 ± 1.0 |
| Reassurance: 6 Months Post-Disclosure | 5.5 ± 1.2 | 5.8 ± 1.3 |
| Advice: 6 Months Post-Disclosure | 5.4 ± 1.3 | 5.6 ± 1.4 |
| Help in decision making: 6 Months Post-Disclosure | 5.2 ± 1.3 | 5.6 ± 1.4 |
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"
| score on a scale | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| 6 Weeks Post-Disclosure | 3.5 ± 0.9 | 3.6 ± 1.0 |
| 6 Months Post-Disclosure | 3.0 ± 0.8 | 3.5 ± 1.0 |
AD prevention behaviors enacted within the prior two weeks.
| Participants | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| Baseline: Diet | 6 | 17 |
| Baseline: Physical activity | 16 | 26 |
| Baseline: Dietary supplements | 7 | 15 |
| Baseline: Mental activities | 13 | 37 |
| Baseline: Stress management | 1 | 10 |
| Baseline: Medications | 8 | 26 |
| 6 Weeks post-disclosure: Diet | 9 | 16 |
| 6 Weeks post-disclosure: Physical activity | 16 | 30 |
| 6 Weeks post-disclosure: Dietary supplements | 9 | 25 |
| 6 Weeks post-disclosure: Mental activities | 12 | 38 |
| 6 Weeks post-disclosure: Stress management | 6 | 20 |
| 6 Weeks post-disclosure: Medications | 7 | 24 |
| 6 Months post-disclosure: Diet | 6 | 20 |
| 6 Months post-disclosure: Physical activity | 12 | 23 |
| 6 Months post-disclosure: Dietary supplements | 9 | 16 |
| 6 Months post-disclosure: Mental activities | 15 | 40 |
| 6 Months post-disclosure: Stress management | 3 | 18 |
| 6 Months post-disclosure: Medications | 4 | 22 |
A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
| Participants | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| Health insurance change | 2 | 1 |
| Life insurance change | 0 | 1 |
| Short-term disability insurance change | 0 | 0 |
| Long-term disability insurance | 0 | 0 |
| Long-term care insurance | 0 | 0 |
| Change to will | 0 | 0 |
| Change to living will | 1 | 1 |
| Change to durable power of attorney | 0 | 0 |
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?"
| Participants | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| 6 Weeks post-disclosure | 0 | 6 |
| 6 Months post-disclosure | 2 | 10 |
Collected over From enrollment through 6 months after the Alzheimer's disease risk assessment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| APOE Genotype Non-Disclosure | 0/39 (0%) | 0/39 (0%) | 16/39 (41%) |
| APOE Genotype Disclosure | 0/75 (0%) | 0/75 (0%) | 18/75 (24%) |
| Event | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
|---|---|---|
| Increased monitoring due to high scores on anxiety, depression or hopelessness scalesPsychiatric disorders | 16/39 | 17/75 |
| Delayed disclosure sessionInvestigations | 0/39 | 1/75 |
| Age, Categorical(Participants) | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 11 | 14 |
| >=65 years | 36 | 64 | 100 |
| Age, Continuous(years) | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| Mean | 75.1 ± 8.1 | 73.3 ± 7.3 | 73.9 ± 7.6 |
| Sex: Female, Male(Participants) | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| Female | 18 | 39 | 57 |
| Male | 21 | 36 | 57 |
| Ethnicity (NIH/OMB)(Participants) | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 36 | 72 | 108 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Race (NIH/OMB)(Participants) | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 11 | 20 |
| White | 30 | 64 | 94 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| United States | 39 | 75 | 125 |
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Brigham and Women's Hospital