Status:
ACTIVE_NOT_RECRUITING
The PACE-DLB Study
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Dementia With Lewy Bodies
Eligibility:
All Genders
Brief Summary
The PACE-DLB Study is for people with at least moderate dementia with Lewy bodies (DLB) and their primary caregiver. The study's goals are to learn more about the experiences of people with DLB and th...
Detailed Description
Dementia with Lewy bodies (DLB) is part of Lewy body dementia, the 2nd-most-common degenerative dementia in the U.S. It is also one of the Alzheimer's disease-related dementias (ADRDs). Evidence-based...
Eligibility Criteria
Inclusion
- Patient and caregiver willing to participate as a dyad (patients will need a legally authorized representative to consent on their behalf given the requirement for at least moderate dementia, but patients who resists participating in the study will not be enrolled)
- U.S. residents (i.e., individuals accessing the LBDA from outside the U.S. will be excluded)
- Patient with a clinical diagnosis of DLB
- Patient with moderate severity dementia as assessed by the Quick Dementia Rating System (QDRS, with a score of \>12 OR ≥2 in at least 3 domains suggestive of moderate dementia)
- Caregiver telephone interview for cognitive status (TICS) score of \>31 to ensure that the caregiver is able to reliably complete study visits
- Patient participant expected to live at least 6 months (so that at least a baseline visit and 1 follow up visits is expected to be completed)
Exclusion
- Patient participant diagnosed with dementia of less than moderate severity
- Patient with dementia resists participation
- Non-U.S. residents
- Patient participant with dementia not expected to live at least 6 months
- Virtual cohort ONLY: Patient participant receives medical care from a LBDA Research Centers of Excellence clinic
Key Trial Info
Start Date :
February 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04829656
Start Date
February 25 2021
End Date
June 1 2026
Last Update
March 4 2025
Active Locations (5)
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1
University of Florida
Gainesville, Florida, United States, 32608
2
University of Miami
Miami, Florida, United States, 33136
3
University of Michigan
Ann Arbor, Michigan, United States, 48105
4
Mayo Clinic
Rochester, Minnesota, United States, 55905