65 and older, any sex, with Mild Cognitive Impairment or Healthy Aging. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comprehension/Recall of Results - Personal Information Score - PARTICIPANTPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
82.40
± 25.07
Amyloid Negative (Tau Positive or Negative) Participants
94.60
± 5.51
1 week after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
69.40
± 27.73
Amyloid Negative (Tau Positive or Negative) Participants
90.80
± 5.76
6 weeks after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
70.00
± 33.56
Amyloid Negative (Tau Positive or Negative) Participants
90.60
± 5.94
Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
91.60
± 12.26
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
96.00
± 5.87
1 week after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
93.20
± 11.69
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
92.00
± 10.95
6 weeks after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
86.00
± 10.23
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
85.20
± 10.69
Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
80.00
± 29.92
Amyloid Negative (Tau Positive or Negative) Participants
83.40
± 15.50
1 week after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
68.20
± 33.72
Amyloid Negative (Tau Positive or Negative) Participants
88.40
± 16.13
6 weeks after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
81.25
± 37.50
Amyloid Negative (Tau Positive or Negative) Participants
90.00
± 22.36
Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
95.00
± 11.18
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
68.40
± 20.74
1 week after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
93.40
± 14.76
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
68.40
± 20.74
6 weeks after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
100.00
± 0.00
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
63.40
± 28.02
Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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
immediately after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
2.50
± 0.58
Amyloid Negative (Tau Positive or Negative) Participants
1.75
± 0.96
1 week after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
1.50
± 0.58
Amyloid Negative (Tau Positive or Negative) Participants
2.25
± 1.50
6 weeks after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
2.25
± 2.06
Amyloid Negative (Tau Positive or Negative) Participants
1.60
± 1.82
Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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
immediately after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
0.25
± 0.50
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
0.00
± 0.00
1 week after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
0.75
± 1.50
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
0.25
± 0.50
6 weeks after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
0.75
± 0.96
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
0.40
± 0.89
Beck Anxiety Inventory (BAI) - PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
6.75
± 8.06
Amyloid Negative (Tau Positive or Negative) Participants
2.25
± 4.50
1 week after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
0.75
± 0.96
Amyloid Negative (Tau Positive or Negative) Participants
1.25
± 1.89
6 weeks after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
0.00
± 0.00
Amyloid Negative (Tau Positive or Negative) Participants
4.00
± 5.15
Beck Anxiety Inventory (BAI) - CO-PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
1.75
± 2.22
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
1.00
± 0.82
1 week after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
3.50
± 6.35
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
0.00
± 0.00
6 weeks after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
5.25
± 6.08
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
1.20
± 1.64
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
immediately after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
14.20
± 5.59
Amyloid Negative (Tau Positive or Negative) Participants
16.80
± 4.15
1 week after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
14.50
± 5.97
Amyloid Negative (Tau Positive or Negative) Participants
18.40
± 2.61
6 weeks after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
9.75
± 5.19
Amyloid Negative (Tau Positive or Negative) Participants
18.40
± 2.19
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
Immediately after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
17.20
± 3.03
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
17.80
± 3.90
1 week after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
10.80
± 4.76
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
19.60
± 0.89
6 weeks after disclosure
Group
Value
95% CI
Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants
10.50
± 1.00
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
19.20
± 1.10
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
Immediately after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
13.60
± 9.66
Amyloid Negative (Tau Positive or Negative) Participants
3.40
± 3.58
1 week after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
5.60
± 7.83
Amyloid Negative (Tau Positive or Negative) Participants
4.20
± 2.78
6 weeks after disclosure
Group
Value
95% CI
Amyloid Positive (Tau Positive or Negative) Participants
5.25
± 6.40
Amyloid Negative (Tau Positive or Negative) Participants
4.00
± 5.15
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTSPrimary· Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
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.
Immediately after disclosure
Group
Value
95% CI
Co-Participants f Amyloid Positive (Tau Positive or Negative) Participants
10.60
± 11.19
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
5.40
± 4.93
1 week after disclosure
Group
Value
95% CI
Co-Participants f Amyloid Positive (Tau Positive or Negative) Participants
18.80
± 14.06
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
2.60
± 2.97
6 weeks after disclosure
Group
Value
95% CI
Co-Participants f Amyloid Positive (Tau Positive or Negative) Participants
9.00
± 9.49
Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants
3.00
± 3.46
Sponsor's own description
The goal of this study is to test efficacy and safety of person-centered, culturally-informed protocols for disclosure of different combinations of Alzheimer's dementia risk factors. Building on the results from a federally-funded assessment of preferences and needs of racially diverse participants and their respective friends/family members, in regard to Dementia - Alzheimer's Type (DAT), we have produced protocols for communication of DAT risk, with attention to specific adaptations in style or content based on individual factors and preferences. These protocols allow for communication of risk based on clinical history and diagnosis, structural neuroimaging, apolipoprotein-E status, and amyloid and tau burden on positron emission tomography. In particular, protocols specify (a) effective methods of communicating risk conferred by each data source, (b) information designed for patients versus informants, (c) psychoeducation needs, and (d) resource/support needs. We will recruit a randomly-selected subset of 10 dyads (including 5 participants who are Non-Hispanic African-American, 5 participants who are Non-Hispanic White) from the Stage I sample to whom we will develop and implement personalized DAT risk disclosure protocols. We will provide preliminary information on the effectiveness of these protocols in terms of patient/co-participant comprehension and recall of feedback provided, and initial changes in mood or behavior immediately following and shortly after risk disclosure sessions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 16 February 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04309500.