Trial Outcomes & Findings for REVEAL III: Risk Evaluation and Education for Alzheimer's Disease (NCT NCT00462917)
NCT ID: NCT00462917
Last Updated: 2018-10-23
Results Overview
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
290 participants
Primary outcome timeframe
6 weeks, 6 months, and 12 months post-disclosure
Results posted on
2018-10-23
Participant Flow
Participant milestones
| Measure |
Pleiotropic Info, In-person Disclosure
Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
72
|
75
|
66
|
77
|
|
Overall Study
Met With Genetic Counselor
|
66
|
71
|
56
|
71
|
|
Overall Study
Received Risk Information
|
64
|
70
|
55
|
68
|
|
Overall Study
Completed 6 Week Follow-up
|
63
|
70
|
55
|
68
|
|
Overall Study
Completed 6 Month Follow-up
|
63
|
68
|
55
|
66
|
|
Overall Study
COMPLETED
|
62
|
65
|
54
|
66
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
REVEAL III: Risk Evaluation and Education for Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Pleiotropic Info, In-person Disclosure
n=64 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
n=70 Participants
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
n=55 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
n=68 Participants
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
57 years
STANDARD_DEVIATION 12 • n=5 Participants
|
57 years
STANDARD_DEVIATION 13 • n=7 Participants
|
59 years
STANDARD_DEVIATION 13 • n=5 Participants
|
59 years
STANDARD_DEVIATION 12 • n=4 Participants
|
58 years
STANDARD_DEVIATION 13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
141 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
116 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
215 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
70 participants
n=7 Participants
|
55 participants
n=5 Participants
|
68 participants
n=4 Participants
|
257 participants
n=21 Participants
|
|
Anxiety (Beck Anxiety Index: BAI)
|
2.7 units on a scale
STANDARD_DEVIATION 2.9 • n=5 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
3.8 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
4.0 units on a scale
STANDARD_DEVIATION 3.8 • n=4 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 3.5 • n=21 Participants
|
|
Depression (Center for Epidemiological Studies Depression Scale: CES-D)
|
5.1 units on a scale
STANDARD_DEVIATION 4.6 • n=5 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 5.0 • n=5 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 5.3 • n=4 Participants
|
5.7 units on a scale
STANDARD_DEVIATION 5.1 • n=21 Participants
|
PRIMARY outcome
Timeframe: 6 weeks, 6 months, and 12 months post-disclosurePopulation: "Number of participants analyzed" are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data.
A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Outcome measures
| Measure |
Pleiotropic Info, In-person Disclosure
n=63 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
n=70 Participants
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
n=55 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
n=68 Participants
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
|---|---|---|---|---|
|
Center for Epidemiological Studies-Depression Scale (CES-D)
6 Weeks
|
4.8 score on a scale
Standard Deviation 5.0
|
7.0 score on a scale
Standard Deviation 8.4
|
6.4 score on a scale
Standard Deviation 6.4
|
5.5 score on a scale
Standard Deviation 5.4
|
|
Center for Epidemiological Studies-Depression Scale (CES-D)
6 Months
|
5.5 score on a scale
Standard Deviation 7.0
|
6.6 score on a scale
Standard Deviation 6.7
|
5.8 score on a scale
Standard Deviation 6.4
|
6.1 score on a scale
Standard Deviation 6.6
|
|
Center for Epidemiological Studies-Depression Scale (CES-D)
12 Months
|
7.1 score on a scale
Standard Deviation 8.2
|
7.6 score on a scale
Standard Deviation 9.0
|
7.1 score on a scale
Standard Deviation 7.0
|
6.2 score on a scale
Standard Deviation 6.9
|
PRIMARY outcome
Timeframe: 6 weeks, 6 months, 12 months post-disclosurePopulation: "Number of participants analyzed" are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data.
A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
Outcome measures
| Measure |
Pleiotropic Info, In-person Disclosure
n=63 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
n=70 Participants
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
n=55 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
n=68 Participants
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
|---|---|---|---|---|
|
Beck Anxiety Inventory (BAI)
6 Weeks
|
2.9 score on a scale
Standard Deviation 3.6
|
4.1 score on a scale
Standard Deviation 5.4
|
3.2 score on a scale
Standard Deviation 4.2
|
3.1 score on a scale
Standard Deviation 3.3
|
|
Beck Anxiety Inventory (BAI)
6 Months
|
3.4 score on a scale
Standard Deviation 5.4
|
3.4 score on a scale
Standard Deviation 4.3
|
3.3 score on a scale
Standard Deviation 3.8
|
3.0 score on a scale
Standard Deviation 5.0
|
|
Beck Anxiety Inventory (BAI)
12 Months
|
3.4 score on a scale
Standard Deviation 5.5
|
4.0 score on a scale
Standard Deviation 5.3
|
3.5 score on a scale
Standard Deviation 3.4
|
3.8 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: 6 weeks, 6 months, 12 months post-disclosurePopulation: "Number of participants analyzed" are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data.
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.
Outcome measures
| Measure |
Pleiotropic Info, In-person Disclosure
n=63 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
n=70 Participants
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
n=55 Participants
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
n=68 Participants
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
|---|---|---|---|---|
|
Impact of Events Scale (IES)
6 Months
|
3.5 score on a scale
Standard Deviation 8.7
|
4.0 score on a scale
Standard Deviation 8.2
|
3.0 score on a scale
Standard Deviation 4.2
|
3.2 score on a scale
Standard Deviation 5.8
|
|
Impact of Events Scale (IES)
6 Weeks
|
3.4 score on a scale
Standard Deviation 6.4
|
4.5 score on a scale
Standard Deviation 7.9
|
3.7 score on a scale
Standard Deviation 6.3
|
3.8 score on a scale
Standard Deviation 7.7
|
|
Impact of Events Scale (IES)
12 Months
|
2.4 score on a scale
Standard Deviation 5.9
|
4.0 score on a scale
Standard Deviation 10.4
|
2.5 score on a scale
Standard Deviation 5.2
|
3.3 score on a scale
Standard Deviation 7.4
|
Adverse Events
Pleiotropic Info, In-person Disclosure
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
AD-only Info, Phone Disclosure
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Pleiotropic Info, Phone Disclosure
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AD-only Info, In-person Disclosure
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pleiotropic Info, In-person Disclosure
n=64 participants at risk
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
n=70 participants at risk
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
n=55 participants at risk
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
n=68 participants at risk
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
|---|---|---|---|---|
|
Social circumstances
Death
|
1.6%
1/64 • Number of events 1
|
0.00%
0/70
|
0.00%
0/55
|
0.00%
0/68
|
Other adverse events
| Measure |
Pleiotropic Info, In-person Disclosure
n=64 participants at risk
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
AD-only Info, Phone Disclosure
n=70 participants at risk
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
Pleiotropic Info, Phone Disclosure
n=55 participants at risk
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.
Genetic counselors communicate results to participants during a telephone disclosure session.
|
AD-only Info, In-person Disclosure
n=68 participants at risk
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.
Genetic counselors communicate results to participants during an in-person disclosure session.
|
|---|---|---|---|---|
|
Psychiatric disorders
Potential mood disorder
|
7.8%
5/64 • Number of events 5
|
11.4%
8/70 • Number of events 8
|
7.3%
4/55 • Number of events 6
|
7.4%
5/68 • Number of events 5
|
|
General disorders
Hospitalization
|
4.7%
3/64 • Number of events 3
|
1.4%
1/70 • Number of events 1
|
0.00%
0/55
|
0.00%
0/68
|
Additional Information
Robert C. Green, MD, MPH
Brigham and Women's Hospital and Harvard Medical School
Phone: 617-264-5838
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place