Trial Outcomes & Findings for Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV (NCT NCT01434667)
NCT ID: NCT01434667
Last Updated: 2018-10-23
Results Overview
A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Results posted on
2018-10-23
Participant Flow
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)
Participant milestones
| Measure |
Apolipoprotein E (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.
|
Apolipoprotein E (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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
75
|
|
Overall Study
COMPLETED
|
34
|
65
|
|
Overall Study
NOT COMPLETED
|
5
|
10
|
Reasons for withdrawal
| Measure |
Apolipoprotein E (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.
|
Apolipoprotein E (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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
10
|
Baseline Characteristics
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Baseline characteristics by cohort
| Measure |
APOE Genotype Non-Disclosure
n=39 Participants
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.
|
APOE Genotype Disclosure
n=75 Participants
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.
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
73.3 years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
73.9 years
STANDARD_DEVIATION 7.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
72 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
64 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
75 participants
n=107 Participants
|
125 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks post-disclosure, and 6 months post-disclosurePopulation: Participants who completed the full 15-item 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.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=39 Participants
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.
|
APOE Genotype Disclosure
n=75 Participants
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.
|
|---|---|---|
|
Geriatric Depression Scale
Baseline
|
2.6 score on a scale
Standard Deviation 2.6
|
2.1 score on a scale
Standard Deviation 2.0
|
|
Geriatric Depression Scale
6 Weeks Post-Disclosure
|
2.8 score on a scale
Standard Deviation 2.7
|
1.9 score on a scale
Standard Deviation 1.6
|
|
Geriatric Depression Scale
6 Months Post-Disclosure
|
2.1 score on a scale
Standard Deviation 2.2
|
2.0 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks post-disclosure, and 6 months post-disclosurePopulation: Participants who completed the full 6-item scale
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.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=39 Participants
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.
|
APOE Genotype Disclosure
n=75 Participants
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.
|
|---|---|---|
|
Mini State Trait Anxiety Inventory
Baseline
|
36.3 score on a scale
Standard Deviation 12.0
|
36.5 score on a scale
Standard Deviation 10.9
|
|
Mini State Trait Anxiety Inventory
6 Weeks Post-Disclosure
|
39.0 score on a scale
Standard Deviation 13.6
|
36.6 score on a scale
Standard Deviation 11.8
|
|
Mini State Trait Anxiety Inventory
6 Months Post-Disclosure
|
36.2 score on a scale
Standard Deviation 12.3
|
36.2 score on a scale
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: 1-3 Days, 6 Weeks and 6 Months Post-disclosurePopulation: Participants who completed the full 15-item scale.
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.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=37 Participants
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.
|
APOE Genotype Disclosure
n=74 Participants
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.
|
|---|---|---|
|
Impact of Event Scale (IES)
1-3 Days Post-Disclosure
|
8.2 score on a scale
Standard Deviation 8.7
|
8.1 score on a scale
Standard Deviation 9.4
|
|
Impact of Event Scale (IES)
6 Weeks Post-Disclosure
|
13.1 score on a scale
Standard Deviation 11.4
|
11.5 score on a scale
Standard Deviation 12.6
|
|
Impact of Event Scale (IES)
6 Months Post-Disclosure
|
12.5 score on a scale
Standard Deviation 11.9
|
12.4 score on a scale
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: 6 Weeks and 6 Months Post-disclosurePopulation: Participants who completed the full 15-item scale
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.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=34 Participants
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.
|
APOE Genotype Disclosure
n=73 Participants
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.
|
|---|---|---|
|
Psychological Impact of Test Disclosure (IGT-AD)
6 Weeks Post-Disclosure
|
24.7 score on a scale
Standard Deviation 10.0
|
19.5 score on a scale
Standard Deviation 11.5
|
|
Psychological Impact of Test Disclosure (IGT-AD)
6 Months Post-Disclosure
|
24.1 score on a scale
Standard Deviation 10.8
|
20.3 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 6 Weeks and 6 Months Post-disclosurePopulation: Participants who provided data on each scale.
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.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=34 Participants
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.
|
APOE Genotype Disclosure
n=63 Participants
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.
|
|---|---|---|
|
Recall and Comprehension of Risk Information
6 Weeks Post-Disclosure
|
0.8 score on a scale
Standard Deviation 0.7
|
1.2 score on a scale
Standard Deviation 0.8
|
|
Recall and Comprehension of Risk Information
6 Months Post-Disclosure
|
1.0 score on a scale
Standard Deviation 0.7
|
1.2 score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 6 Weeks and 6 Months Post-disclosurePopulation: Participants who provided responses on each expectation item
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.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=37 Participants
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.
|
APOE Genotype Disclosure
n=73 Participants
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.
|
|---|---|---|
|
Participant Satisfaction
Information: 6 Weeks Post-Disclosure
|
6.0 score on a scale
Standard Deviation 1.1
|
6.1 score on a scale
Standard Deviation 1.2
|
|
Participant Satisfaction
Explanation: 6 Weeks Post-Disclosure
|
5.9 score on a scale
Standard Deviation 1.2
|
6.2 score on a scale
Standard Deviation 1.2
|
|
Participant Satisfaction
Reassurance: 6 Weeks Post-Disclosure
|
5.5 score on a scale
Standard Deviation 1.5
|
6.0 score on a scale
Standard Deviation 1.3
|
|
Participant Satisfaction
Advice: 6 Weeks Post-Disclosure
|
5.6 score on a scale
Standard Deviation 1.4
|
5.4 score on a scale
Standard Deviation 1.7
|
|
Participant Satisfaction
Help in decision making: 6 Weeks Post-Disclosure
|
5.2 score on a scale
Standard Deviation 1.7
|
5.3 score on a scale
Standard Deviation 1.6
|
|
Participant Satisfaction
Information: 6 Months Post-Disclosure
|
5.6 score on a scale
Standard Deviation 1.4
|
6.1 score on a scale
Standard Deviation 1.2
|
|
Participant Satisfaction
Explanation: 6 Months Post-Disclosure
|
5.7 score on a scale
Standard Deviation 1.3
|
6.2 score on a scale
Standard Deviation 1.0
|
|
Participant Satisfaction
Reassurance: 6 Months Post-Disclosure
|
5.5 score on a scale
Standard Deviation 1.2
|
5.8 score on a scale
Standard Deviation 1.3
|
|
Participant Satisfaction
Advice: 6 Months Post-Disclosure
|
5.4 score on a scale
Standard Deviation 1.3
|
5.6 score on a scale
Standard Deviation 1.4
|
|
Participant Satisfaction
Help in decision making: 6 Months Post-Disclosure
|
5.2 score on a scale
Standard Deviation 1.3
|
5.6 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 6 Weeks and 6 Months Post-disclosurePopulation: Participants who completed these items in the post-disclosure surveys.
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"
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=35 Participants
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.
|
APOE Genotype Disclosure
n=73 Participants
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.
|
|---|---|---|
|
User Ratings of Risk Assessment Experience
6 Weeks Post-Disclosure
|
3.5 score on a scale
Standard Deviation 0.9
|
3.6 score on a scale
Standard Deviation 1.0
|
|
User Ratings of Risk Assessment Experience
6 Months Post-Disclosure
|
3.0 score on a scale
Standard Deviation 0.8
|
3.5 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks post-disclosure, and 6 months post-disclosurePopulation: Participants who provided data on health behaviors at each time point.
AD prevention behaviors enacted within the prior two weeks.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=39 Participants
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.
|
APOE Genotype Disclosure
n=75 Participants
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.
|
|---|---|---|
|
Health Behavior and Insurance Changes
Baseline: Diet
|
6 Participants
|
17 Participants
|
|
Health Behavior and Insurance Changes
Baseline: Physical activity
|
16 Participants
|
26 Participants
|
|
Health Behavior and Insurance Changes
Baseline: Dietary supplements
|
7 Participants
|
15 Participants
|
|
Health Behavior and Insurance Changes
Baseline: Mental activities
|
13 Participants
|
37 Participants
|
|
Health Behavior and Insurance Changes
Baseline: Stress management
|
1 Participants
|
10 Participants
|
|
Health Behavior and Insurance Changes
Baseline: Medications
|
8 Participants
|
26 Participants
|
|
Health Behavior and Insurance Changes
6 Weeks post-disclosure: Diet
|
9 Participants
|
16 Participants
|
|
Health Behavior and Insurance Changes
6 Weeks post-disclosure: Physical activity
|
16 Participants
|
30 Participants
|
|
Health Behavior and Insurance Changes
6 Weeks post-disclosure: Dietary supplements
|
9 Participants
|
25 Participants
|
|
Health Behavior and Insurance Changes
6 Weeks post-disclosure: Mental activities
|
12 Participants
|
38 Participants
|
|
Health Behavior and Insurance Changes
6 Weeks post-disclosure: Stress management
|
6 Participants
|
20 Participants
|
|
Health Behavior and Insurance Changes
6 Weeks post-disclosure: Medications
|
7 Participants
|
24 Participants
|
|
Health Behavior and Insurance Changes
6 Months post-disclosure: Diet
|
6 Participants
|
20 Participants
|
|
Health Behavior and Insurance Changes
6 Months post-disclosure: Physical activity
|
12 Participants
|
23 Participants
|
|
Health Behavior and Insurance Changes
6 Months post-disclosure: Dietary supplements
|
9 Participants
|
16 Participants
|
|
Health Behavior and Insurance Changes
6 Months post-disclosure: Mental activities
|
15 Participants
|
40 Participants
|
|
Health Behavior and Insurance Changes
6 Months post-disclosure: Stress management
|
3 Participants
|
18 Participants
|
|
Health Behavior and Insurance Changes
6 Months post-disclosure: Medications
|
4 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 6 months post-disclosurePopulation: Participants who provided data on the 6-month follow-up survey about these outcomes
A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=31 Participants
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.
|
APOE Genotype Disclosure
n=64 Participants
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.
|
|---|---|---|
|
Insurance and Advance Planning Changes
Health insurance change
|
2 Participants
|
1 Participants
|
|
Insurance and Advance Planning Changes
Life insurance change
|
0 Participants
|
1 Participants
|
|
Insurance and Advance Planning Changes
Short-term disability insurance change
|
0 Participants
|
0 Participants
|
|
Insurance and Advance Planning Changes
Long-term disability insurance
|
0 Participants
|
0 Participants
|
|
Insurance and Advance Planning Changes
Long-term care insurance
|
0 Participants
|
0 Participants
|
|
Insurance and Advance Planning Changes
Change to will
|
0 Participants
|
0 Participants
|
|
Insurance and Advance Planning Changes
Change to living will
|
1 Participants
|
1 Participants
|
|
Insurance and Advance Planning Changes
Change to durable power of attorney
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 weeks and 6 months post-disclosurePopulation: Participants who provided data on these survey items
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?"
Outcome measures
| Measure |
APOE Genotype Non-Disclosure
n=37 Participants
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.
|
APOE Genotype Disclosure
n=74 Participants
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.
|
|---|---|---|
|
Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.
6 Weeks post-disclosure
|
0 Participants
|
6 Participants
|
|
Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.
6 Months post-disclosure
|
2 Participants
|
10 Participants
|
Adverse Events
APOE Genotype Non-Disclosure
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
APOE Genotype Disclosure
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
APOE Genotype Non-Disclosure
n=39 participants at risk
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.
|
APOE Genotype Disclosure
n=75 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Increased monitoring due to high scores on anxiety, depression or hopelessness scales
|
41.0%
16/39 • From enrollment through 6 months after the Alzheimer's disease risk assessment.
Non-serious adverse events were defined as scores at any time including baseline, on psychological outcome scales greater than or equal to 56 on the STAI (anxiety), 8 on the GDS (depression) or 2 on the BHS (hopelessness). Non-serious adverse events were identified at the judgment of study personnel as events that caused inconvenience or concern to participants, but did not qualify as serious. Serious adverse events were defined per guidelines from the National Institutes of Aging.
|
22.7%
17/75 • From enrollment through 6 months after the Alzheimer's disease risk assessment.
Non-serious adverse events were defined as scores at any time including baseline, on psychological outcome scales greater than or equal to 56 on the STAI (anxiety), 8 on the GDS (depression) or 2 on the BHS (hopelessness). Non-serious adverse events were identified at the judgment of study personnel as events that caused inconvenience or concern to participants, but did not qualify as serious. Serious adverse events were defined per guidelines from the National Institutes of Aging.
|
|
Investigations
Delayed disclosure session
|
0.00%
0/39 • From enrollment through 6 months after the Alzheimer's disease risk assessment.
Non-serious adverse events were defined as scores at any time including baseline, on psychological outcome scales greater than or equal to 56 on the STAI (anxiety), 8 on the GDS (depression) or 2 on the BHS (hopelessness). Non-serious adverse events were identified at the judgment of study personnel as events that caused inconvenience or concern to participants, but did not qualify as serious. Serious adverse events were defined per guidelines from the National Institutes of Aging.
|
1.3%
1/75 • From enrollment through 6 months after the Alzheimer's disease risk assessment.
Non-serious adverse events were defined as scores at any time including baseline, on psychological outcome scales greater than or equal to 56 on the STAI (anxiety), 8 on the GDS (depression) or 2 on the BHS (hopelessness). Non-serious adverse events were identified at the judgment of study personnel as events that caused inconvenience or concern to participants, but did not qualify as serious. Serious adverse events were defined per guidelines from the National Institutes of Aging.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place