N/A
N=20
SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting
Mild Cognitive Impairment · Healthy Aging
Bottom Line
View on ClinicalTrials.gov: NCT04309500 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Comprehension/Recall of Results - Personal Information Score - PARTICIPANT — 82.40; 94.60; 69.40; 90.80 percentage correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Personalized DAT Risk Disclosure Protocol (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comprehension/Recall of Results - Personal Information Score - PARTICIPANT |
82.40; 94.60; 69.40; 90.80; 70.00; 90.60 | — |
| PRIMARY Comprehension/Recall of Results - Personal Information Score - CO-PARTICIPANTS |
91.60; 96.00; 93.20; 92.00; 86.00; 85.20 | — |
| PRIMARY Comprehension/Recall of Results - Meaning of Risk Information Score - PARTICIPANTS |
80.00; 83.40; 68.20; 88.40; 81.25; 90.00 | — |
| PRIMARY Comprehension/Recall of Results - Meaning of Risk Information Score - CO-PARTICIPANTS |
95.00; 68.40; 93.40; 68.40; 100.00; 63.40 | — |
| PRIMARY Geriatric Depression Scale - Short Form (GDS-15) - PARTICIPANTS |
2.50; 1.75; 1.50; 2.25; 2.25; 1.60 | — |
| PRIMARY Geriatric Depression Scale - Short Form (GDS-15) - CO-PARTICIPANTS |
0.25; 0.00; 0.75; 0.25; 0.75; 0.40 | — |
| PRIMARY Beck Anxiety Inventory (BAI) - PARTICIPANTS |
6.75; 2.25; 0.75; 1.25; 0.00; 4.00 | — |
| PRIMARY Beck Anxiety Inventory (BAI) - CO-PARTICIPANTS |
1.75; 1.00; 3.50; 0.00; 5.25; 1.20 | — |
| PRIMARY The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - PARTICIPANTS |
14.20; 16.80; 14.50; 18.40; 9.75; 18.40 | — |
| PRIMARY The Impact of Genetic Testing for AD (IGT-AD; Positive Subscale) - CO-PARTICIPANTS |
17.20; 17.80; 10.80; 19.60; 10.50; 19.20 | — |
| PRIMARY The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - PARTICIPANTS |
13.60; 3.40; 5.60; 4.20; 5.25; 4.00 | — |
| PRIMARY The Impact of Genetic Testing for AD (IGT-AD; Distress Subscale) - CO-PARTICIPANTS |
10.60; 5.40; 18.80; 2.60; 9.00; 3.00 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04309500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.