Trial Outcomes & Findings for SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting (NCT NCT04309500)
NCT ID: NCT04309500
Last Updated: 2023-02-16
Results Overview
Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Results posted on
2023-02-16
Participant Flow
Participant milestones
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
Immediate
|
5
|
5
|
5
|
5
|
|
Overall Study
1 Week Later
|
5
|
5
|
5
|
5
|
|
Overall Study
6 Weeks Later
|
4
|
5
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
Baseline Characteristics
SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting
Baseline characteristics by cohort
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Study partners of participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Study partners of participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
75.00 years
STANDARD_DEVIATION 5.15 • n=5 Participants
|
72.60 years
STANDARD_DEVIATION 5.41 • n=7 Participants
|
69.80 years
STANDARD_DEVIATION 5.54 • n=5 Participants
|
75.40 years
STANDARD_DEVIATION 10.50 • n=4 Participants
|
73.20 years
STANDARD_DEVIATION 6.83 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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)
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
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
14 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
|
Continuous Years of Education
|
17.20 years
STANDARD_DEVIATION 3.03 • n=5 Participants
|
17.80 years
STANDARD_DEVIATION 3.77 • n=7 Participants
|
16.20 years
STANDARD_DEVIATION 3.03 • n=5 Participants
|
17.40 years
STANDARD_DEVIATION 4.88 • n=4 Participants
|
17.15 years
STANDARD_DEVIATION 3.50 • n=21 Participants
|
|
Baseline Beck Anxiety Inventory (BAI)
|
2.20 score on a scale
STANDARD_DEVIATION 2.95 • n=5 Participants
|
2.00 score on a scale
STANDARD_DEVIATION 3.08 • n=7 Participants
|
4.40 score on a scale
STANDARD_DEVIATION 4.56 • n=5 Participants
|
2.00 score on a scale
STANDARD_DEVIATION 2.55 • n=4 Participants
|
2.65 score on a scale
STANDARD_DEVIATION 3.27 • n=21 Participants
|
|
Baseline Geriatric Depression Scale (GDS)
|
0.80 score on a scale
STANDARD_DEVIATION 0.84 • n=5 Participants
|
1.40 score on a scale
STANDARD_DEVIATION 0.89 • n=7 Participants
|
0.60 score on a scale
STANDARD_DEVIATION 1.34 • n=5 Participants
|
0.40 score on a scale
STANDARD_DEVIATION 0.55 • n=4 Participants
|
0.80 score on a scale
STANDARD_DEVIATION 0.95 • n=21 Participants
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session.
Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Comprehension/Recall of Results - Personal Information Score - PARTICIPANT
immediately after disclosure
|
82.40 percentage correct
Standard Deviation 25.07
|
94.60 percentage correct
Standard Deviation 5.51
|
|
Comprehension/Recall of Results - Personal Information Score - PARTICIPANT
1 week after disclosure
|
69.40 percentage correct
Standard Deviation 27.73
|
90.80 percentage correct
Standard Deviation 5.76
|
|
Comprehension/Recall of Results - Personal Information Score - PARTICIPANT
6 weeks after disclosure
|
70.00 percentage correct
Standard Deviation 33.56
|
90.60 percentage correct
Standard Deviation 5.94
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week evaluation.
Co-participants were asked a series of multiple choice and true/false questions about their understanding or memory of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity. Scores were on a range of 0 - 100 percent correct.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS
immediately after disclosure
|
91.60 percentage correct
Standard Deviation 12.26
|
96.00 percentage correct
Standard Deviation 5.87
|
|
Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS
1 week after disclosure
|
93.20 percentage correct
Standard Deviation 11.69
|
92.00 percentage correct
Standard Deviation 10.95
|
|
Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS
6 weeks after disclosure
|
86.00 percentage correct
Standard Deviation 10.23
|
85.20 percentage correct
Standard Deviation 10.69
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session.
Participants were asked a series of multiple choice and true/false questions about their understanding or memory of the meaning of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity (i.e., whether their profile on each of these indicators was related to increased, decreased, or unclear risk for DAT). Scores were on a range of 0 - 100 percent correct.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS
immediately after disclosure
|
80.00 percentage correct
Standard Deviation 29.92
|
83.40 percentage correct
Standard Deviation 15.50
|
|
Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS
1 week after disclosure
|
68.20 percentage correct
Standard Deviation 33.72
|
88.40 percentage correct
Standard Deviation 16.13
|
|
Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS
6 weeks after disclosure
|
81.25 percentage correct
Standard Deviation 37.50
|
90.00 percentage correct
Standard Deviation 22.36
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week evaluation.
Co-participants were asked a series of multiple choice and true/false questions about their understanding or memory of the meaning of the participant's current diagnosis, structural neuroimaging, APO-E genotype, and amyloid and/or tau positivity (i.e., whether their profile on each of these indicators was related to increased, decreased, or unclear risk for DAT). Scores were on a range of 0 - 100 percent correct.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS
immediately after disclosure
|
95.00 percentage correct
Standard Deviation 11.18
|
68.40 percentage correct
Standard Deviation 20.74
|
|
Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS
1 week after disclosure
|
93.40 percentage correct
Standard Deviation 14.76
|
68.40 percentage correct
Standard Deviation 20.74
|
|
Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS
6 weeks after disclosure
|
100.00 percentage correct
Standard Deviation 0.00
|
63.40 percentage correct
Standard Deviation 28.02
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: GDS was erroneously not collected for 1 participant in each arm at the immediate and 1-week time point. 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session.
A 15-item assessment of depressive symptoms that was adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms).Participant were asked to rate the presence of mood symptoms over the past two weeks. Scores for the assessment ranged from 0-15, with higher scores indicating more depressive symptoms
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS
immediately after disclosure
|
2.50 score on a scale
Standard Deviation 0.58
|
1.75 score on a scale
Standard Deviation 0.96
|
|
Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS
1 week after disclosure
|
1.50 score on a scale
Standard Deviation 0.58
|
2.25 score on a scale
Standard Deviation 1.50
|
|
Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS
6 weeks after disclosure
|
2.25 score on a scale
Standard Deviation 2.06
|
1.60 score on a scale
Standard Deviation 1.82
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: GDS was erroneously not collected for 1 study partner in each arm at the immediate and 1-week time point. 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week follow-up, as it fell outside of the study funding period.
A 15-item assessment of depressive symptoms that was adapted to remove common depression symptoms often conflated with normal aging (i.e., somatic symptoms). Co-participant were asked to rate the presence of mood symptoms over the past two weeks. Scores for the assessment ranged from 0-15, with higher scores indicating more depressive symptoms
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS
1 week after disclosure
|
0.75 score on a scale
Standard Deviation 1.50
|
0.25 score on a scale
Standard Deviation 0.50
|
|
Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS
immediately after disclosure
|
0.25 score on a scale
Standard Deviation 0.50
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS
6 weeks after disclosure
|
0.75 score on a scale
Standard Deviation 0.96
|
0.40 score on a scale
Standard Deviation 0.89
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: BAI was erroneously not collected for 1 participant in each arm at the immediate and 1-week time point. 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session.
A 21-item measure of the perceived severity ('not at all' to 'severely') at which the participant was experiencing anxiety symptoms over the past week, validated for use with older adults. Scores ranged from 0-63, with higher scores indicating greater anxiety.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) - PARTICIPANTS
1 week after disclosure
|
0.75 score on a scale
Standard Deviation 0.96
|
1.25 score on a scale
Standard Deviation 1.89
|
|
Beck Anxiety Inventory (BAI) - PARTICIPANTS
immediately after disclosure
|
6.75 score on a scale
Standard Deviation 8.06
|
2.25 score on a scale
Standard Deviation 4.50
|
|
Beck Anxiety Inventory (BAI) - PARTICIPANTS
6 weeks after disclosure
|
0.00 score on a scale
Standard Deviation 0.00
|
4.00 score on a scale
Standard Deviation 5.15
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: BAI was erroneously not collected for 1 study partner in each arm at the immediate and 1-week time point. 1 study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week follow-up, as it fell outside of the study funding period.
A 21-item measure of the perceived severity ('not at all' to 'severely') at which the co-participant was experiencing anxiety symptoms over the past week, validated for use with older adults. Scores ranged from 0-63, with higher scores indicating greater anxiety.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS
immediately after disclosure
|
1.75 score on a scale
Standard Deviation 2.22
|
1.00 score on a scale
Standard Deviation 0.82
|
|
Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS
1 week after disclosure
|
3.50 score on a scale
Standard Deviation 6.35
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS
6 weeks after disclosure
|
5.25 score on a scale
Standard Deviation 6.08
|
1.20 score on a scale
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session.
The Impact of Genetic Testing for AD (IGT-AD) (positive subscale) was a 4-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. Possible scores ranged from 0 - 60, where 0 meant fewest positive reactions and 20 was most (strongest) positive reactions.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS
immediately after disclosure
|
14.20 score on a scale
Standard Deviation 5.59
|
16.80 score on a scale
Standard Deviation 4.15
|
|
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS
1 week after disclosure
|
14.50 score on a scale
Standard Deviation 5.97
|
18.40 score on a scale
Standard Deviation 2.61
|
|
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS
6 weeks after disclosure
|
9.75 score on a scale
Standard Deviation 5.19
|
18.40 score on a scale
Standard Deviation 2.19
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: One study partner in the "Co-Participants of Amyloid Positive" arm did not complete the 6-week follow-up as it fell outside of the study funding period.
The Impact of Genetic Testing for AD (IGT-AD) (positive subscale) was a 4-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Co-participants completed this to assess their reactions to the participant receiving risk feedback. Scores ranged from 0 - 60, where 0 meant fewest positive reactions and 20 was most (strongest) positive reactions.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS
Immediately after disclosure
|
17.20 score on a scale
Standard Deviation 3.03
|
17.80 score on a scale
Standard Deviation 3.90
|
|
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS
1 week after disclosure
|
10.80 score on a scale
Standard Deviation 4.76
|
19.60 score on a scale
Standard Deviation 0.89
|
|
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS
6 weeks after disclosure
|
10.50 score on a scale
Standard Deviation 1.00
|
19.20 score on a scale
Standard Deviation 1.10
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: 1 participant in the "Amyloid Positive" arm completed the immediately after disclosure and 1-week follow-up sessions but was lost to follow-up prior to the 6-week session.
The Impact of Genetic Testing for AD (IGT-AD) was a 16-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. The Distress subscale scores ranged from 0-60, with higher scores indicating greater distress about test results.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS
Immediately after disclosure
|
13.60 score on a scale
Standard Deviation 9.66
|
3.40 score on a scale
Standard Deviation 3.58
|
|
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS
1 week after disclosure
|
5.60 score on a scale
Standard Deviation 7.83
|
4.20 score on a scale
Standard Deviation 2.78
|
|
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS
6 weeks after disclosure
|
5.25 score on a scale
Standard Deviation 6.40
|
4.00 score on a scale
Standard Deviation 5.15
|
PRIMARY outcome
Timeframe: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosurePopulation: One participant in the "Co-Participant of Amyloid Positive" arm did not complete the 6-week follow-up as it fell outside of the study funding period.
The Impact of Genetic Testing for AD (IGT-AD) was a 16-item self-report measure that assessed two positive and negative emotional responses to genetic AD risk disclosure. This scale was adapted to more broadly assess the 'life event' of receiving DAT risk disclosure based on multiple indicators. Participants completed this to assess their reactions to the participant receiving risk feedback. The Distress subscale scores ranged from 0-60, with higher scores indicating greater distress about test results.
Outcome measures
| Measure |
Amyloid Positive (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes.
Personalized Dementia - Alzheimer's Type (DAT) Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
Amyloid Negative (Tau Positive or Negative) Participants
n=5 Participants
Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes.
Personalized DAT Risk Disclosure Protocol: Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
|
|---|---|---|
|
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS
Immediately after disclosure
|
10.60 score on a scale
Standard Deviation 11.19
|
5.40 score on a scale
Standard Deviation 4.93
|
|
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS
1 week after disclosure
|
18.80 score on a scale
Standard Deviation 14.06
|
2.60 score on a scale
Standard Deviation 2.97
|
|
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS
6 weeks after disclosure
|
9.00 score on a scale
Standard Deviation 9.49
|
3.00 score on a scale
Standard Deviation 3.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Administered immediately after risk disclosure; 1 week later, and 6 weeks laterParticipants and co-participants were asked to explain, in their own words and without cuing, their impressions of the messages they received about the participant's clinical history, structural neuroimaging, genetic profile, and amyloid and tau biomarkers, as well as the risk for DAT conferred by those markers. Responses were transcribed and coded to determine core themes and understanding of risk messages.
Outcome measures
Outcome data not reported
Adverse Events
Amyloid Positive (Tau Positive or Negative) Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amyloid Negative (Tau Positive or Negative) Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place