What this study is
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 enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal [18F]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer [18F]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of [18F]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal [18F]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with [18F]DPA-714-PET/MRI.
What's being tested
- DPA-714-PET/MRI
Intervention · DRUG
DPA-714-PET/MRI
- 5-year Follow-up DPA-714-PET/MRI
Intervention · DRUG
PET/MRI scan with DPA-714
- DPA-714 Metabolite Analysis
Intervention · DRUG
Participants will have an arterial line placed in their lower forearm immediately before DPA-714 PET/MRI. Serial blood samples will be pulled at specific time points during the dynamic PET/MRI.
Study details
- Official title
- UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Parkinson Disease
- Enrolling
- 205 people
- Starts
- 2018-03-22
- Est. completion
- 2028-06
- Design
- Open-label, non-randomized, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 30 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
- Parkinson's Disease participant enrolled in UDALL Baseline Cohort. Baseline imaging to be completed no more than 6 years prior.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUAB Advanced Imaging Facility
Birmingham, Alabama, United States
- Evan Hudson · Contact205-996-1082evanhudson@uabmc.edu
Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-300001025
Principal investigator
Jonathan McConathy, MD
University of Alabama at Birmingham
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.