SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting

NCT04309500 | Completed Results

• 2 other identifiers: HUM001788691R03AG063222-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Mild Cognitive Impairment; Healthy Aging

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  Administered immediately after risk disclosure, at 1 week, and at 6 weeks after disclosure

Other Outcomes (1)

• Comprehension of Results - Qualitative Impressions

  Administered immediately after risk disclosure; 1 week later, and 6 weeks later

Study Arms (4)

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.

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.

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.

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.

Behavioral: Personalized DAT Risk Disclosure Protocol

Interventions

Personalized DAT Risk Disclosure Protocol BEHAVIORAL

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; 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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan Medical School, Department of Psychiatry

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Annalise M. Rahman-Filipiak
• Organization: University of Michigan

rahmanam@med.umich.edu

734-763-9259

Study Officials

• Annalise M Rahman-Filipiak, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 16, 2020
• Study Start: May 20, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 16, 2023
• Results First Posted: February 16, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)