Mild Cognitive ImpairmentSHARE(D)NCT04309500
SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting
A study testing Personalized DAT Risk Disclosure Protocol in people with Mild Cognitive Impairment and Healthy Aging, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Healthy Aging
- What is being tested?
- Personalized DAT Risk Disclosure Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age 65+ years
- Non-Hispanic Black or Non-Hispanic White race/ethnicity
- Previously participated in Stage I (observational needs assessment)
- Have completed an initial evaluation as part of the University of Michigan Memory and Aging Project (UM-MAP), Stimulation to Improve Memory (STIM) study, or the DAPPER study within the last 12 months.
- Diagnosed with normal cognition or mild cognitive impairment (MCI; single- or -multiple domain, amnestic or non-amnestic forms)
- Able to identify a co-participant who is currently the participant's caregiver, or would serve in this role in the future if needed, and well-known to the participant (known for ≥5 years and have at least weekly phone or in-person contact)
- Able to identify a co-participant who is 18+ years old.
- Able to identify a co-participant who is cognitively healthy
Who cannot join
- Current or historical neurologic disorder (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
- Current or historical significant neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of consciousness > 5 minutes, presence of significant post-traumatic amnesia, or the need for extended hospitalization or intervention).
- Motor symptoms indicative of a neurodegenerative etiology other than Alzheimer's disease
- Severe mental illness (i.e., bipolar disorder, thought disorder, psychosis)
- Severe substance use disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Medical School, Department of Psychiatry
Ann Arbor, Michigan, 48105
About this study
Official title: Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure
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.
Read the detailed description
Currently, a divide exists between Dementia - Alzheimer's Type (DAT) risk information that is shared in clinical settings versus genetic and biomarker-based risk information gathered and, less frequently, disseminated in research settings. Clinical feedback continues to discuss DAT risk in terms of personal/family history, neuropsychological or neurological testing, and standard neuroimaging reports. Research advances in genotyping, quantitative neuroimaging, and amyloid and tau positron emission tomography (PET) have improved our risk prediction and disease staging; however, the literature on how to share these important findings is sparse. Effective risk disclosure protocols are fundamentally dependent on the needs of recipients. However, we do not know how patients, or those tasked with current or future caregiving, decide what sources or types of risk information they want disclosed, nor their reasons for preferring certain types of information over others. Given the differences between static (e.g., family history, genotyping) and dynamic, potentially modifiable risk factors (e.g., amyloid burden), as well as varying familiarity with research-based biomarkers, it is especially important to understand how much information patients hope to receive and what they hope to do with it. This knowledge gap is particularly pertinent in minority and low-income populations given systemic challenges and cultural beliefs that may affect their psychological, physical, and financial ability to adapt to a high risk profile. Thus, understanding risk disclosure needs and preferences is a critical step in developing culturally-informed feedback protocols.
Aim 1 (accomplished during the Stage I observational Needs Assessment - HUM00160276) was to investigate the preferences and needs of racially diverse participants, and their respective informants, in regards to receiving feedback about their risk for DAT.
Aim 2 is to develop person-centered, culturally-informed protocols for disclosure of different combinations of Alzheimer's dementia risk factors. Building on the results of Aim 1, we have produced protocols for communication of DAT risk, with attention to specific adaptations in style or content based on individual factors and preferences. 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.
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Being tested
- Personalized DAT Risk Disclosure Protocol
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized DAT Risk Disclosure ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Amyloid Positive (Tau Positive or Negative) Participants | Experimental | Participants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. Receives: Behavioral: Personalized DAT Risk Disclosure Protocol |
| Amyloid Negative (Tau Positive or Negative) Participants | Experimental | Participants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. Receives: Behavioral: Personalized DAT Risk Disclosure Protocol |
| Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants | Experimental | 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. Receives: Behavioral: Personalized DAT Risk Disclosure Protocol |
| Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants | Experimental | 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. Receives: Behavioral: Personalized DAT Risk Disclosure Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension/Recall of Results - Personal Information Score - PARTICIPANT
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS
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
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS
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
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Beck Anxiety Inventory (BAI) - PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS
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.
Measured: 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) - PARTICIPANTS
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.
Measured: 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) - CO-PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS
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.
Measured: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start20 May 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Stage II will involve a clinical trial, with the risk disclosure feedback serving as the behavioral intervention. The study will use a single-group design with no control group. All 10 participant-co-participant dyads (5 Non-Hispanic African-American, 5 Non-Hispanic White) will receive feedback about the participant's DAT risk. Outcomes will be measured immediately following feedback and at 1- and 6-weeks following risk disclosure.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Annalise Rahman-Filipiak, University of Michigan
- Investigators
- Annalise M Rahman-Filipiak, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309500
- Sponsor's protocol ID
- HUM00178869
- Other IDs
- 1R03AG063222-01
- Acronym
- SHARE(D)
- Status last verified
- Jan 2023
- First submitted
- 10 Mar 2020
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Culturally-Sensitive and Patient-Centered Feedback for Alzheimer's Dementia Risk Disclosure
- ClinicalTrials.gov ID
- NCT04309500
- Acronym / sponsor ID
- SHARE(D) / HUM00178869
- Conditions
- Mild Cognitive Impairment, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Currently, a divide exists between Dementia - Alzheimer's Type (DAT) risk information that is shared in clinical settings versus genetic and biomarker-based risk information gathered and, less frequently, disseminated in research settings. Clinical feedback continues to discuss DAT risk in terms of personal/family history, neuropsychological or neurological testing, and standard neuroimaging reports. Research advances in genotyping, quantitative neuroimaging, and amyloid and tau positron emission tomography (PET) have improved our risk prediction and disease staging; however, the literature on how to share these important findings is sparse. Effective risk disclosure protocols are fundamentally dependent on the needs of recipients. However, we do not know how patients, or those tasked with current or future caregiving, decide what sources or types of risk information they want disclosed, nor their reasons for preferring certain types of information over others. Given the differences between static (e.g., family history, genotyping) and dynamic, potentially modifiable risk factors (e.g., amyloid burden), as well as varying familiarity with research-based biomarkers, it is especially important to understand how much information patients hope to receive and what they hope to do with it. This knowledge gap is particularly pertinent in minority and low-income populations given systemic challenges and cultural beliefs that may affect their psychological, physical, and financial ability to adapt to a high risk profile. Thus, understanding risk disclosure needs and preferences is a critical step in developing culturally-informed feedback protocols.
Aim 1 (accomplished during the Stage I observational Needs Assessment - HUM00160276) was to investigate the preferences and needs of racially diverse participants, and their respective informants, in regards to receiving feedback about their risk for DAT.
Aim 2 is to develop person-centered, culturally-informed protocols for disclosure of different combinations of Alzheimer's dementia risk factors. Building on the results of Aim 1, we have produced protocols for communication of DAT risk, with attention to specific adaptations in style or content based on individual factors and preferences. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Stage II will involve a clinical trial, with the risk disclosure feedback serving as the behavioral intervention. The study will use a single-group design with no control group. All 10 participant-co-participant dyads (5 Non-Hispanic African-American, 5 Non-Hispanic White) will receive feedback about the participant's DAT risk. Outcomes will be measured immediately following feedback and at 1- and 6-weeks following risk disclosure.
| Arm | Type | Receives |
|---|---|---|
| Amyloid Positive (Tau Positive or Negative) Participants | Experimental | Behavioral: Personalized DAT Risk Disclosure ProtocolParticipants who receive results of elevated amyloid (whether or not tau is also elevated), indicating the presence of Alzheimer's disease brain changes. |
| Amyloid Negative (Tau Positive or Negative) Participants | Experimental | Behavioral: Personalized DAT Risk Disclosure ProtocolParticipants who receive results of not-elevated amyloid (whether or not tau is elevated), indicating the absence of Alzheimer's disease brain changes. |
| Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants | Experimental | Behavioral: Personalized DAT Risk Disclosure ProtocolStudy 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. |
| Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants | Experimental | Behavioral: Personalized DAT Risk Disclosure ProtocolStudy 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- age 65+ years
- Non-Hispanic Black or Non-Hispanic White race/ethnicity
- Previously participated in Stage I (observational needs assessment)
- Have completed an initial evaluation as part of the University of Michigan Memory and Aging Project (UM-MAP), Stimulation to Improve Memory (STIM) study, or the DAPPER study within the last 12 months.
- Diagnosed with normal cognition or mild cognitive impairment (MCI; single- or -multiple domain, amnestic or non-amnestic forms)
Key exclusion criteria (5 listed)
- Current or historical neurologic disorder (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
- Current or historical significant neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of consciousness > 5 minutes, presence of significant post-traumatic amnesia, or the need for extended hospitalization or intervention).
- Motor symptoms indicative of a neurodegenerative etiology other than Alzheimer's disease
- Severe mental illness (i.e., bipolar disorder, thought disorder, psychosis)
- Severe substance use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized DAT Risk Disclosure ProtocolIndividual 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. | Behavioural | Amyloid Negative (Tau Positive or Negative) Participants, Amyloid Positive (Tau Positive or Negative) Participants, Co-Participants of Amyloid Negative (Tau Positive or Negative) Participants, Co-Participants of Amyloid Positive (Tau Positive or Negative) Participants |
Primary outcome
Comprehension/Recall of Results - Personal Information Score - PARTICIPANT
Time frame: 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.
Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS
Time frame: 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.
Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS
Time frame: 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.
Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS
Time frame: 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.
Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS
Time frame: 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
Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS
Time frame: 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
Beck Anxiety Inventory (BAI) - PARTICIPANTS
Time frame: 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.
Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS
Time frame: 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.
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS
Time frame: 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.
The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS
Time frame: 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.
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS
Time frame: 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.
The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No individual participant data will be made available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annalise M Rahman-Filipiak, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized DAT Risk Disclosure Protocol in people with Mild Cognitive Impairment and Healthy Aging, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension/Recall of Results - Personal Information Score - PARTICIPANT (time frame: Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.