Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT06289582
- Phase
- EARLY_PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Accepted
Interventions
- [F-18]DPA714 administration IV — DRUGbrain PET/MRI imaging after \[F-18\]DPA-714 administration
Study Details
The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714
Key Dates
- Start date
- Aug 14, 2024
- Status verified
- Dec 2025
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 60 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Prodromal and manifest (PD) participants
- Experimental: Healthy participants
Primary Outcome Measure
Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. [ Time Frame: 24 months ]
Central Contacts
- Evan Hudson205-934-6499
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UAB | Birmingham | Alabama | 35294 | Jonathan McConathy, MD,PhD (PRINCIPAL_INVESTIGATOR) |
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