Parkinson DiseasePhase 1/2NCT03457493
The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
A Phase 1/2 study testing DPA-714-PET/MRI, 5-year Follow-up DPA-714-PET/MRI and DPA-714 Metabolite Analysis in people with Parkinson Disease, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- DPA-714-PET/MRI, 5-year Follow-up DPA-714-PET/MRI and DPA-714 Metabolite Analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2018to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB Advanced Imaging Facility
Birmingham, Alabama, 35294
Evan Hudson, 205-996-1082, evanhudson@uabmc.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- DPA-714-PET/MRI, 5-year Follow-up DPA-714-PET/MRI, DPA-714 Metabolite Analysis
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPA-714-PET/MRIDrug
DPA-714-PET/MRI
5-year Follow-up DPA-714-PET/MRIDrug
PET/MRI scan with DPA-714
DPA-714 Metabolite AnalysisDrug
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 group | Role | What they receive |
|---|---|---|
| Baseline Cohort Healthy Controls, DPA-714-PET/MRI | Experimental | n-105 Receives: Drug: DPA-714-PET/MRI |
| Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI | Experimental | n-100 Receives: Drug: DPA-714-PET/MRI |
| UDALL 5-year Follow-up Cohort | Experimental | n-67 from baseline early Parkinson's disease cohort Receives: Drug: 5-year Follow-up DPA-714-PET/MRI |
| Metabolite Analysis Cohort | Experimental | n-5 from baseline early Parkinson's disease cohort Receives: Drug: DPA-714 Metabolite Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls.
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.
Measured: 2 years
Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start22 Mar 2018
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deepak Prabataram Kalbi, University of Alabama at Birmingham
- Investigators
- Jonathan McConathy, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457493
- Sponsor's protocol ID
- IRB-300001025
- Other IDs
- MJFF-024254
- Status last verified
- Aug 2026
- First submitted
- 23 Feb 2018
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
- ClinicalTrials.gov ID
- NCT03457493
- Acronym / sponsor ID
- IRB-300001025
- Conditions
- Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baseline Cohort Healthy Controls, DPA-714-PET/MRI | Experimental | Drug: DPA-714-PET/MRIn-105 |
| Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI | Experimental | Drug: DPA-714-PET/MRIn-100 |
| UDALL 5-year Follow-up Cohort | Experimental | Drug: 5-year Follow-up DPA-714-PET/MRIn-67 from baseline early Parkinson's disease cohort |
| Metabolite Analysis Cohort | Experimental | Drug: DPA-714 Metabolite Analysisn-5 from baseline early Parkinson's disease cohort |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPA-714-PET/MRIDPA-714-PET/MRI | Drug | Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI, Baseline Cohort Healthy Controls, DPA-714-PET/MRI |
| 5-year Follow-up DPA-714-PET/MRIPET/MRI scan with DPA-714 | Drug | UDALL 5-year Follow-up Cohort |
| DPA-714 Metabolite AnalysisParticipants 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. | Drug | Metabolite Analysis Cohort |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan McConathy, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DPA-714-PET/MRI, 5-year Follow-up DPA-714-PET/MRI and DPA-714 Metabolite Analysis in people with Parkinson Disease, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan McConathy, MD (205-996-7115, jmcconathy@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.