Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
NCT04829656
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04829656
Study Brief:
Protocol Section:
NCT04829656