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NCT04829656 · ClinicalTrials.gov registry record
The PACE-DLB Study
A clinical trial, sponsored by University of Florida.
- Completed
- Registry status
- 378
- Enrollment target
NCT04829656: Completed study, sponsored by University of Florida.
NCT04829656 is a clinical trial that has completed, run by University of Florida. The registered enrollment target is 378 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04829656 has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- 378 participants
- Enrollment target
Study 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 their caregivers as DLB progresses, and what happens as the end of life of the person with DLB approaches. Participants are enrolled through one of five Lewy Body Dementia Association (LBDA) Research Center of Excellence clinics, or directly via the LBDA. People with DLB will enroll into the study along with their primary informal caregiver, such as the family member or friend who is involved in most of their care and attends the majority of their medical appointments. A legally authorized representative (LAR) for the person with DLB will consent to participate in the study on the person's behalf. If the person with DLB resists taking part in the study, the pair will not be enrolled. The study consists of questionnaires about the progression of the person's dementia and the experiences of the caregiver. The person with DLB will complete one questionnaire themselves if they are able to. If the pair is enrolled at a LBDA Research Center of Excellence clinical site, and completes study visits in-person, a brief physical exam of the person with DLB will be completed by a clinician. Study participation will last for three years, or until the person with DLB dies. Study visits take place every six months, either virtually or in person at a clinical study site. If the person with DLB dies during the study, the caregiver will complete one final virtual study visit three months afterward. Specific Aims of the PACE-DLB Study: 1. To determine predictors of the end of life (death within 6 months) in the DLB population. Hypotheses: Predictors of death within 6 months for individuals with DLB will include symptoms (e.g. worsening hallucinations, fluctuations) not captured in existing dementia end-of-life prediction tools. 2. To identify whether change in caregiver measures can
Primary Outcome
The investigators define a variable that predicts the end of life as a variable changing substantially (e.g., quick drop of quality of life) once the patient enters last six months of life. The investigators will model and estimate the longitudinal trajectories of all potential candidate variables to identify those with significantly different trajectory patterns in the last six months of life.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 378 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2025-12-31 |
What the finished NCT04829656 record still lists
NCT04829656 is an observational study that tracks outcomes without assigning an intervention. The registered 378 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT04829656 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04829656 about?
NCT04829656 is a clinical study titled "The PACE-DLB Study". 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 their caregivers as DLB progresses, and what happens as the end of life of the person with DLB approac...
What is the current status of trial NCT04829656?
This trial is currently completed. The enrollment target is 378 participants. The study started on 2021-02-25. Estimated completion is 2025-12-31.
Who is sponsoring clinical trial NCT04829656?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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