NCT03457493 The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
| NCT ID | NCT03457493 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Alabama at Birmingham |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 205 participants |
| Start Date | 2018-03-22 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 205 participants in total. It began in 2018-03-22 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria for all cohorts: 1. 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) 2. 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. 3. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. Exclusion Criteria for all cohorts: 1. 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. 2. Contraindication to MRI and/or PET imaging 3. Inability to participate in the imaging studies due to severity of PD or other medical comorbidities. 4. 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.
Contact & Investigator
Jonathan McConathy, MD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT03457493 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03457493 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT03457493 currently recruiting?
Yes, NCT03457493 is actively recruiting participants. Contact the research team at jmcconathy@uabmc.edu for enrollment information.
Where is the NCT03457493 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT03457493 clinical trial?
NCT03457493 is sponsored by University of Alabama at Birmingham. The principal investigator is Jonathan McConathy, MD at University of Alabama at Birmingham. The trial plans to enroll 205 participants.
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