The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy

April 24, 2026 updated by: Jonathan E McConathy, University of Alabama at Birmingham

UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal 18F-DPA-714 Imaging in a Parkinson Disease Cohort studies. The UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) study and the Longitudinal 18F-DPA-714 Imaging in a Parkinson Disease Cohort study are separate studies reviewed by the UAB IRB (IRB-300001745 and IRB-300011684 respectively, PI Yacoubian). Each study includes participants with clinically diagnosed PD and healthy controls. This sub-study will examine the role of the immune system, particularly the innate immune system, in the pathophysiology of PD. TSPO is increased during neuroinflammation and is a marker of activated microglia. The PET tracer [18F]DPA-714 will be used to image neuroinflammation in the brains of study participants and will be correlated with clinical data collected through participation in the UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and the Longitudinal 18F-DPA-714 Imaging in a Parkinson Disease Cohort studies. Study participants will be divided into three cohorts; 100 PD participants and 100 healthy volunteers will be enrolled in the UDALL Baseline Cohort, sixty-seven PD participants from the UDALL Baseline Cohort will be enrolled in the UDALL 5-year Follow-up Cohort, and 5 PD participants will be enrolled in the Metabolite Analysis Cohort.

UDALL Baseline Cohort) Participants eligible through enrollment in the UAB Neuroinflammation PD study will be consented for one-time DPA-714 PET/MRI imaging. Imaging results will be correlated with demographics and clinical and biospecimen assessment from the Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) study.In the baseline cohort, we are enrolling subjects to examine the role of brain and systemic inflammation at diagnosis in patients in the early stages of PD. For this study, we are enrolling 100 healthy volunteers and 100 PD participants who will undergo clinical analysis, DPA 714 scans, and plasma and cerebrospinal fluid (CSF) analysis. These subjects will be followed longitudinally in the associated UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) study in order to determine whether DPA 714 signal correlates with other biomarkers of inflammation in the blood or CSF and whether DPA 714 signal predicts motor or cognitive decline over time.

UDALL 5-year Follow-up Cohort) 67 PD participants from the UDALL Baseline Cohort will be consented. Participants will receive follow-up DPA-714 PET/MRI imaging approximately 5 years after baseline imaging. Imaging results will be correlated with demographics and clinical and biospecimen assessment from the Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) study.In interval analysis of the original Udall cohort, we observed increased brain inflammation as determined by DPA-714 scans in patients newly diagnosed with PD at baseline compared to health controls. An unknown question is whether this brain inflammation is maintained throughout the disease course. Therefore, we will rescan with DPA-714 subjects 5 years after enrollment who had scans done at baseline (n=67). This will help answer whether brain inflammation changes over time.

Metabolite Analysis Cohort) Five PD participants eligible through enrollment in the UAB Neuroinflammation PD study will be consented for one-time DPA-714 PET/MRI imaging, arterial line placement and metabolite sampling. Imaging results will be correlated with demographics and clinical and biospecimen assessment from the Longitudinal 18F-DPA-714 Imaging in a Parkinson Disease Cohort study. For the metabolite analysis cohort, we will enroll 5 subjects to perform metabolite analysis to validate previous studies that DPA 714 signal in the brain is not affected by metabolism of the radioligand at our center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • UAB Advanced Imaging Facility
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Baseline Cohort Healthy Controls, DPA-714-PET/MRI
n-105
Drug: DPA-714-PET/MRI
DPA-714-PET/MRI
Experimental: Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI
n-100
Drug: DPA-714-PET/MRI
DPA-714-PET/MRI
Experimental: UDALL 5-year Follow-up Cohort
n-67 from baseline early Parkinson's disease cohort
Drug: 5-year Follow-up DPA-714-PET/MRI
PET/MRI scan with DPA-714
Experimental: Metabolite Analysis Cohort
n-5 from baseline early Parkinson's disease cohort
Drug: DPA-714 Metabolite Analysis
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls.
Time Frame: 2 years
Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. TSPO-PET measures will be compared between PD patients and healthy controls. We expect the PD patients to have higher measures of neuroinflammation than healthy controls.
2 years
Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study
Time Frame: 2 years
The estimates of neuroinflammation measured with TSPO-PET will be correlated with clinical assessments of PD severity and biospecimens collected through the UAB Neuroinflammation in PD study.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan McConathy, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB-300001025
  • MJFF-024254 (Other Grant/Funding Number: Michael J. Fox Foundation for Parkinson's Disease Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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