Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01434667
Collaborator
National Human Genome Research Institute (NHGRI) (NIH), University of Michigan (Other), University of Pennsylvania (Other), Howard University (Other)
146
3
2
53.9
48.7
0.9

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
  • Behavioral: APOE genotype and Alzheimer's disease risk disclosure
  • Behavioral: Alzheimer's disease risk disclosure
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

Study Type:
Interventional
Actual Enrollment :
146 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

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

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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"

  6. Health Behavior and Insurance Changes [Baseline, 6 weeks post-disclosure, and 6 months post-disclosure]

    AD prevention behaviors enacted within the prior two weeks.

  7. 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.

  8. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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:

Publications

Responsible Party:
Robert C. Green, MD, MPH, Principal Investigator, The REVEAL Study, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01434667
Other Study ID Numbers:
  • R01HG002213
  • R01HG002213
First Posted:
Sep 15, 2011
Last Update Posted:
Oct 23, 2018
Last Verified:
Sep 1, 2018
Keywords provided by Robert C. Green, MD, MPH, Principal Investigator, The REVEAL Study, Brigham and Women's Hospital
Additional relevant MeSH terms:

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

1. Primary Outcome
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)
2. Primary Outcome
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)
3. Secondary Outcome
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)
4. Secondary Outcome
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)
5. Secondary Outcome
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)
6. Secondary Outcome
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)
7. Secondary Outcome
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)
8. Secondary Outcome
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%
9. Secondary Outcome
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%
10. Secondary Outcome
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
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
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

[Not Specified]

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
Organization Brigham and Women's Hospital
Phone (617) 264-5883
Email kchristensen@bwh.harvard.edu
Responsible Party:
Robert C. Green, MD, MPH, Principal Investigator, The REVEAL Study, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01434667
Other Study ID Numbers:
  • R01HG002213
  • R01HG002213
First Posted:
Sep 15, 2011
Last Update Posted:
Oct 23, 2018
Last Verified:
Sep 1, 2018