Status:
RECRUITING
The University of Alabama At Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in participants ...
Detailed Description
This clinical imaging sub-study will use the small molecule translocator protein (TSPO) ligand, 18F-labeled DPA-714, to visualize and quantify neuroinflammation in individuals participating in the UAB...
Eligibility Criteria
Inclusion
- Inclusion Criteria for all cohorts:
- Enrollment in either the UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) study or UAB Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort study under the separate UAB-approved research protocols (IRB-300001745 and IRB-300011684 respectively, PI Yacoubian)
- Negative urine or serum Human chorionic gonadotropin (hCG) test within 2 days of \[18F\]DPA-714-PET administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
- High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- Exclusion Criteria for all cohorts:
- Meets any exclusion criteria for the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) study or UAB Longitudinal \[18F\]DPA-714 Imaging in a Parkinson's Disease Cohort study.
- Contraindication to MRI and/or PET imaging
- Inability to participate in the imaging studies due to severity of PD or other medical comorbidities.
- Low-affinity binder for TSPO ligands based on genotyping for SNP rs6971.
- Inclusion Criteria specific for UDALL 5-year Follow-up Cohort
- 1\. Parkinson's Disease participant enrolled in UDALL Baseline Cohort. Baseline imaging to be completed no more than 6 years prior.
- Inclusion of Women and Minorities
- Participants 30 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.
Exclusion
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT03457493
Start Date
March 22 2018
End Date
June 1 2027
Last Update
March 5 2025
Active Locations (1)
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1
UAB Advanced Imaging Facility
Birmingham, Alabama, United States, 35294