Status:
COMPLETED
SHARE(D) Stage II: Alzheimer's Risk Disclosure Protocol Piloting
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Healthy Aging
Eligibility:
All Genders
65+ years
Phase:
NA
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 r...
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 frequen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04309500
Start Date
May 20 2021
End Date
January 31 2022
Last Update
February 16 2023
Active Locations (1)
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1
University of Michigan Medical School, Department of Psychiatry
Ann Arbor, Michigan, United States, 48105