Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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"
- Health Behavior and Insurance Changes [Baseline, 6 weeks post-disclosure, and 6 months post-disclosure]
AD prevention behaviors enacted within the prior two weeks.
- 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?"
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Howard University | Washington | District of Columbia | United States | 20060 |
2 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
3 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- National Human Genome Research Institute (NHGRI)
- University of Michigan
- University of Pennsylvania
- Howard University
Investigators
- Principal Investigator: Robert C Green, MD, MPH, Brigham and Women's Hospital/Harvard Medical School
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Alzheimer's Association - Educational Materials on Mild Cognitive Impairment
- Alzheimer's Association - Educational Materials on Risk Factors
- REVEAL Study overview
Publications
- Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18. Review.
- Roberts JS, Karlawish JH, Uhlmann WR, Petersen RC, Green RC. Mild cognitive impairment in clinical care: a survey of American Academy of Neurology members. Neurology. 2010 Aug 3;75(5):425-31. doi: 10.1212/WNL.0b013e3181eb5872.
- R01HG002213
- R01HG002213
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | 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) |
Arm/Group Title | Apolipoprotein E (APOE) Genotype Non-Disclosure | Apolipoprotein E (APOE) Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Period Title: Overall Study | ||
STARTED | 39 | 75 |
COMPLETED | 34 | 65 |
NOT COMPLETED | 5 | 10 |
Baseline Characteristics
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | Total |
---|---|---|---|
Arm/Group Description | 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. | 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 of all reporting groups |
Overall Participants | 39 | 75 | 114 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
3
7.7%
|
11
14.7%
|
14
12.3%
|
>=65 years |
36
92.3%
|
64
85.3%
|
100
87.7%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
75.1
(8.1)
|
73.3
(7.3)
|
73.9
(7.6)
|
Sex: Female, Male (Count of Participants) | |||
Female |
18
46.2%
|
39
52%
|
57
50%
|
Male |
21
53.8%
|
36
48%
|
57
50%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
2
5.1%
|
1
1.3%
|
3
2.6%
|
Not Hispanic or Latino |
36
92.3%
|
72
96%
|
108
94.7%
|
Unknown or Not Reported |
1
2.6%
|
2
2.7%
|
3
2.6%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
9
23.1%
|
11
14.7%
|
20
17.5%
|
White |
30
76.9%
|
64
85.3%
|
94
82.5%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
39
100%
|
75
100%
|
125
109.6%
|
Outcome Measures
Title | Geriatric Depression Scale |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who completed the full 15-item scale. |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 75 |
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)
|
Title | Mini State Trait Anxiety Inventory |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who completed the full 6-item scale |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 75 |
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)
|
Title | Impact of Event Scale (IES) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who completed the full 15-item scale. |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 37 | 74 |
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)
|
Title | Psychological Impact of Test Disclosure (IGT-AD) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who completed the full 15-item scale |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 34 | 73 |
6 Weeks Post-Disclosure |
24.7
(10.0)
|
19.5
(11.5)
|
6 Months Post-Disclosure |
24.1
(10.8)
|
20.3
(11.2)
|
Title | Recall and Comprehension of Risk Information |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who provided data on each scale. |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 34 | 63 |
6 Weeks Post-Disclosure |
0.8
(0.7)
|
1.2
(0.8)
|
6 Months Post-Disclosure |
1.0
(0.7)
|
1.2
(0.7)
|
Title | Participant Satisfaction |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who provided responses on each expectation item |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 37 | 73 |
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)
|
Title | User Ratings of Risk Assessment Experience |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who completed these items in the post-disclosure surveys. |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 35 | 73 |
6 Weeks Post-Disclosure |
3.5
(0.9)
|
3.6
(1.0)
|
6 Months Post-Disclosure |
3.0
(0.8)
|
3.5
(1.0)
|
Title | Health Behavior and Insurance Changes |
---|---|
Description | AD prevention behaviors enacted within the prior two weeks. |
Time Frame | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure |
Outcome Measure Data
Analysis Population Description |
---|
Participants who provided data on health behaviors at each time point. |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 39 | 75 |
Baseline: Diet |
6
15.4%
|
17
22.7%
|
Baseline: Physical activity |
16
41%
|
26
34.7%
|
Baseline: Dietary supplements |
7
17.9%
|
15
20%
|
Baseline: Mental activities |
13
33.3%
|
37
49.3%
|
Baseline: Stress management |
1
2.6%
|
10
13.3%
|
Baseline: Medications |
8
20.5%
|
26
34.7%
|
6 Weeks post-disclosure: Diet |
9
23.1%
|
16
21.3%
|
6 Weeks post-disclosure: Physical activity |
16
41%
|
30
40%
|
6 Weeks post-disclosure: Dietary supplements |
9
23.1%
|
25
33.3%
|
6 Weeks post-disclosure: Mental activities |
12
30.8%
|
38
50.7%
|
6 Weeks post-disclosure: Stress management |
6
15.4%
|
20
26.7%
|
6 Weeks post-disclosure: Medications |
7
17.9%
|
24
32%
|
6 Months post-disclosure: Diet |
6
15.4%
|
20
26.7%
|
6 Months post-disclosure: Physical activity |
12
30.8%
|
23
30.7%
|
6 Months post-disclosure: Dietary supplements |
9
23.1%
|
16
21.3%
|
6 Months post-disclosure: Mental activities |
15
38.5%
|
40
53.3%
|
6 Months post-disclosure: Stress management |
3
7.7%
|
18
24%
|
6 Months post-disclosure: Medications |
4
10.3%
|
22
29.3%
|
Title | Insurance and Advance Planning Changes |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who provided data on the 6-month follow-up survey about these outcomes |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 31 | 64 |
Health insurance change |
2
5.1%
|
1
1.3%
|
Life insurance change |
0
0%
|
1
1.3%
|
Short-term disability insurance change |
0
0%
|
0
0%
|
Long-term disability insurance |
0
0%
|
0
0%
|
Long-term care insurance |
0
0%
|
0
0%
|
Change to will |
0
0%
|
0
0%
|
Change to living will |
1
2.6%
|
1
1.3%
|
Change to durable power of attorney |
0
0%
|
0
0%
|
Title | Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Participants who provided data on these survey items |
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure |
---|---|---|
Arm/Group Description | 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. | 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. |
Measure Participants | 37 | 74 |
6 Weeks post-disclosure |
0
0%
|
6
8%
|
6 Months post-disclosure |
2
5.1%
|
10
13.3%
|
Adverse Events
Time Frame | From enrollment through 6 months after the Alzheimer's disease risk assessment. | |||
---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||
Arm/Group Title | APOE Genotype Non-Disclosure | APOE Genotype Disclosure | ||
Arm/Group Description | 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. | 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. | ||
All Cause Mortality |
||||
APOE Genotype Non-Disclosure | APOE Genotype Disclosure | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/39 (0%) | 0/75 (0%) | ||
Serious Adverse Events |
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APOE Genotype Non-Disclosure | APOE Genotype Disclosure | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/39 (0%) | 0/75 (0%) | ||
Other (Not Including Serious) Adverse Events |
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APOE Genotype Non-Disclosure | APOE Genotype Disclosure | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 16/39 (41%) | 18/75 (24%) | ||
Investigations | ||||
Delayed disclosure session | 0/39 (0%) | 1/75 (1.3%) | ||
Psychiatric disorders | ||||
Increased monitoring due to high scores on anxiety, depression or hopelessness scales | 16/39 (41%) | 17/75 (22.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Kurt Christensen, PhD |
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Organization | Brigham and Women's Hospital |
Phone | (617) 264-5883 |
kchristensen@bwh.harvard.edu |
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