Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment (MCI), Alzheimer's disease (AD), APOE, genetics, risk assessment, education, genetic counseling, Mild Cognitive Impairment, So Stated
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.
Interventions
BEHAVIORALAPOE 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.
BEHAVIORALAlzheimer'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.
Sponsors
National Human Genome Research Institute (NHGRI)
University of Michigan
University of Pennsylvania
Howard University
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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? |
| Health Behavior and Insurance Changes | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | AD prevention behaviors enacted within the prior two weeks. |
| 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. |
Countries
United States
Participant flow
Pre-assignment details
32 enrolled participants were not assigned for the reasons that follow: Ineligible (n=7) * No study partner: 5 * Diagnosis was not amnestic mild cognitive impairment (MCI): 1 * Low cognitive score: 1 Declined to continue (n=17) * No longer interested: n=11 * Too busy: 4 * No reason given: 2 Lost to follow-up (n=8)
Participants by arm
| Arm | Count |
|---|---|
| APOE Genotype Non-Disclosure Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
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. | 39 |
| 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.
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. | 75 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 10 |
Baseline characteristics
| Characteristic | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 64 Participants | 100 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 11 Participants | 14 Participants |
| Age, Continuous | 75.1 years STANDARD_DEVIATION 8.1 | 73.3 years STANDARD_DEVIATION 7.3 | 73.9 years STANDARD_DEVIATION 7.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 72 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 11 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 64 Participants | 94 Participants |
| Region of Enrollment United States | 39 participants | 75 participants | 125 participants |
| Sex: Female, Male Female | 18 Participants | 39 Participants | 57 Participants |
| Sex: Female, Male Male | 21 Participants | 36 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 75 |
| other Total, other adverse events | 16 / 39 | 18 / 75 |
| serious Total, serious adverse events | 0 / 39 | 0 / 75 |
Outcome results
Primary
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
Population: Participants who completed the full 15-item scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | Geriatric Depression Scale | Baseline | 2.6 score on a scale | Standard Deviation 2.6 |
| APOE Genotype Non-Disclosure | Geriatric Depression Scale | 6 Weeks Post-Disclosure | 2.8 score on a scale | Standard Deviation 2.7 |
| APOE Genotype Non-Disclosure | Geriatric Depression Scale | 6 Months Post-Disclosure | 2.1 score on a scale | Standard Deviation 2.2 |
| APOE Genotype Disclosure | Geriatric Depression Scale | Baseline | 2.1 score on a scale | Standard Deviation 2 |
| APOE Genotype Disclosure | Geriatric Depression Scale | 6 Weeks Post-Disclosure | 1.9 score on a scale | Standard Deviation 1.6 |
| APOE Genotype Disclosure | Geriatric Depression Scale | 6 Months Post-Disclosure | 2.0 score on a scale | Standard Deviation 2.1 |
Primary
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
Population: Participants who completed the full 6-item scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | Mini State Trait Anxiety Inventory | Baseline | 36.3 score on a scale | Standard Deviation 12 |
| APOE Genotype Non-Disclosure | Mini State Trait Anxiety Inventory | 6 Weeks Post-Disclosure | 39.0 score on a scale | Standard Deviation 13.6 |
| APOE Genotype Non-Disclosure | Mini State Trait Anxiety Inventory | 6 Months Post-Disclosure | 36.2 score on a scale | Standard Deviation 12.3 |
| APOE Genotype Disclosure | Mini State Trait Anxiety Inventory | Baseline | 36.5 score on a scale | Standard Deviation 10.9 |
| APOE Genotype Disclosure | Mini State Trait Anxiety Inventory | 6 Weeks Post-Disclosure | 36.6 score on a scale | Standard Deviation 11.8 |
| APOE Genotype Disclosure | Mini State Trait Anxiety Inventory | 6 Months Post-Disclosure | 36.2 score on a scale | Standard Deviation 13.4 |
Secondary
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
Population: Participants who provided data on health behaviors at each time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | Baseline: Medications | 8 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | Baseline: Diet | 6 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | Baseline: Physical activity | 16 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | Baseline: Dietary supplements | 7 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | Baseline: Mental activities | 13 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | Baseline: Stress management | 1 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Diet | 9 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Physical activity | 16 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Dietary supplements | 9 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Mental activities | 12 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Stress management | 6 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Medications | 7 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Diet | 6 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Physical activity | 12 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Dietary supplements | 9 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Mental activities | 15 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Stress management | 3 Participants |
| APOE Genotype Non-Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Medications | 4 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Physical activity | 23 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Mental activities | 38 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | Baseline: Diet | 17 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Medications | 22 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | Baseline: Physical activity | 26 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Stress management | 20 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | Baseline: Dietary supplements | 15 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Dietary supplements | 16 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | Baseline: Mental activities | 37 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Medications | 24 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | Baseline: Stress management | 10 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | Baseline: Medications | 26 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Stress management | 18 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Diet | 16 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Diet | 20 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Physical activity | 30 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Months post-disclosure: Mental activities | 40 Participants |
| APOE Genotype Disclosure | Health Behavior and Insurance Changes | 6 Weeks post-disclosure: Dietary supplements | 25 Participants |
Secondary
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
Population: Participants who completed the full 15-item scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | Impact of Event Scale (IES) | 1-3 Days Post-Disclosure | 8.2 score on a scale | Standard Deviation 8.7 |
| APOE Genotype Non-Disclosure | Impact of Event Scale (IES) | 6 Weeks Post-Disclosure | 13.1 score on a scale | Standard Deviation 11.4 |
| APOE Genotype Non-Disclosure | Impact of Event Scale (IES) | 6 Months Post-Disclosure | 12.5 score on a scale | Standard Deviation 11.9 |
| APOE Genotype Disclosure | Impact of Event Scale (IES) | 1-3 Days Post-Disclosure | 8.1 score on a scale | Standard Deviation 9.4 |
| APOE Genotype Disclosure | Impact of Event Scale (IES) | 6 Weeks Post-Disclosure | 11.5 score on a scale | Standard Deviation 12.6 |
| APOE Genotype Disclosure | Impact of Event Scale (IES) | 6 Months Post-Disclosure | 12.4 score on a scale | Standard Deviation 12 |
Secondary
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
Population: Participants who provided data on the 6-month follow-up survey about these outcomes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Health insurance change | 2 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Life insurance change | 0 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Short-term disability insurance change | 0 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Long-term disability insurance | 0 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Long-term care insurance | 0 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Change to will | 0 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Change to living will | 1 Participants |
| APOE Genotype Non-Disclosure | Insurance and Advance Planning Changes | Change to durable power of attorney | 0 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Change to durable power of attorney | 0 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Health insurance change | 1 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Long-term care insurance | 0 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Life insurance change | 1 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Change to living will | 1 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Short-term disability insurance change | 0 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Change to will | 0 Participants |
| APOE Genotype Disclosure | Insurance and Advance Planning Changes | Long-term disability insurance | 0 Participants |
Secondary
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
Population: Participants who provided responses on each expectation item
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | Participant Satisfaction | Information: 6 Weeks Post-Disclosure | 6.0 score on a scale | Standard Deviation 1.1 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Explanation: 6 Weeks Post-Disclosure | 5.9 score on a scale | Standard Deviation 1.2 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Reassurance: 6 Weeks Post-Disclosure | 5.5 score on a scale | Standard Deviation 1.5 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Advice: 6 Weeks Post-Disclosure | 5.6 score on a scale | Standard Deviation 1.4 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Help in decision making: 6 Weeks Post-Disclosure | 5.2 score on a scale | Standard Deviation 1.7 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Information: 6 Months Post-Disclosure | 5.6 score on a scale | Standard Deviation 1.4 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Explanation: 6 Months Post-Disclosure | 5.7 score on a scale | Standard Deviation 1.3 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Reassurance: 6 Months Post-Disclosure | 5.5 score on a scale | Standard Deviation 1.2 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Advice: 6 Months Post-Disclosure | 5.4 score on a scale | Standard Deviation 1.3 |
| APOE Genotype Non-Disclosure | Participant Satisfaction | Help in decision making: 6 Months Post-Disclosure | 5.2 score on a scale | Standard Deviation 1.3 |
| APOE Genotype Disclosure | Participant Satisfaction | Reassurance: 6 Months Post-Disclosure | 5.8 score on a scale | Standard Deviation 1.3 |
| APOE Genotype Disclosure | Participant Satisfaction | Information: 6 Weeks Post-Disclosure | 6.1 score on a scale | Standard Deviation 1.2 |
| APOE Genotype Disclosure | Participant Satisfaction | Information: 6 Months Post-Disclosure | 6.1 score on a scale | Standard Deviation 1.2 |
| APOE Genotype Disclosure | Participant Satisfaction | Explanation: 6 Weeks Post-Disclosure | 6.2 score on a scale | Standard Deviation 1.2 |
| APOE Genotype Disclosure | Participant Satisfaction | Help in decision making: 6 Months Post-Disclosure | 5.6 score on a scale | Standard Deviation 1.4 |
| APOE Genotype Disclosure | Participant Satisfaction | Reassurance: 6 Weeks Post-Disclosure | 6.0 score on a scale | Standard Deviation 1.3 |
| APOE Genotype Disclosure | Participant Satisfaction | Explanation: 6 Months Post-Disclosure | 6.2 score on a scale | Standard Deviation 1 |
| APOE Genotype Disclosure | Participant Satisfaction | Advice: 6 Weeks Post-Disclosure | 5.4 score on a scale | Standard Deviation 1.7 |
| APOE Genotype Disclosure | Participant Satisfaction | Advice: 6 Months Post-Disclosure | 5.6 score on a scale | Standard Deviation 1.4 |
| APOE Genotype Disclosure | Participant Satisfaction | Help in decision making: 6 Weeks Post-Disclosure | 5.3 score on a scale | Standard Deviation 1.6 |
Secondary
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
Population: Participants who provided data on these survey items
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| APOE Genotype Non-Disclosure | Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. | 6 Weeks post-disclosure | 0 Participants |
| APOE Genotype Non-Disclosure | Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. | 6 Months post-disclosure | 2 Participants |
| APOE Genotype Disclosure | Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. | 6 Weeks post-disclosure | 6 Participants |
| APOE Genotype Disclosure | Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. | 6 Months post-disclosure | 10 Participants |
Secondary
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
Population: Participants who completed the full 15-item scale
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | Psychological Impact of Test Disclosure (IGT-AD) | 6 Weeks Post-Disclosure | 24.7 score on a scale | Standard Deviation 10 |
| APOE Genotype Non-Disclosure | Psychological Impact of Test Disclosure (IGT-AD) | 6 Months Post-Disclosure | 24.1 score on a scale | Standard Deviation 10.8 |
| APOE Genotype Disclosure | Psychological Impact of Test Disclosure (IGT-AD) | 6 Weeks Post-Disclosure | 19.5 score on a scale | Standard Deviation 11.5 |
| APOE Genotype Disclosure | Psychological Impact of Test Disclosure (IGT-AD) | 6 Months Post-Disclosure | 20.3 score on a scale | Standard Deviation 11.2 |
Secondary
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
Population: Participants who provided data on each scale.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | Recall and Comprehension of Risk Information | 6 Weeks Post-Disclosure | 0.8 score on a scale | Standard Deviation 0.7 |
| APOE Genotype Non-Disclosure | Recall and Comprehension of Risk Information | 6 Months Post-Disclosure | 1.0 score on a scale | Standard Deviation 0.7 |
| APOE Genotype Disclosure | Recall and Comprehension of Risk Information | 6 Weeks Post-Disclosure | 1.2 score on a scale | Standard Deviation 0.8 |
| APOE Genotype Disclosure | Recall and Comprehension of Risk Information | 6 Months Post-Disclosure | 1.2 score on a scale | Standard Deviation 0.7 |
Secondary
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
Population: Participants who completed these items in the post-disclosure surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APOE Genotype Non-Disclosure | User Ratings of Risk Assessment Experience | 6 Weeks Post-Disclosure | 3.5 score on a scale | Standard Deviation 0.9 |
| APOE Genotype Non-Disclosure | User Ratings of Risk Assessment Experience | 6 Months Post-Disclosure | 3.0 score on a scale | Standard Deviation 0.8 |
| APOE Genotype Disclosure | User Ratings of Risk Assessment Experience | 6 Weeks Post-Disclosure | 3.6 score on a scale | Standard Deviation 1 |
| APOE Genotype Disclosure | User Ratings of Risk Assessment Experience | 6 Months Post-Disclosure | 3.5 score on a scale | Standard Deviation 1 |