Recruiting
Phase 1
Phase 2

DPA-714

Sponsor:

University of Alabama at Birmingham

Code:

NCT03457493

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

Interventions

DPA-714-PET/MRI

5-year Follow-up DPA-714-PET/MRI

DPA-714 Metabolite Analysis

Study Details

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.

Conditions

Parkinson Disease

Study ID

NCT03457493

Start date

Mar 22, 2018

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30+

Healthy Volunteers: Accepted

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 Design

Enrollment

205 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Baseline Cohort Healthy Controls, DPA-714-PET/MRI

n-105

experimental: Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI

n-100

experimental: UDALL 5-year Follow-up Cohort

n-67 from baseline early Parkinson's disease cohort

experimental: Metabolite Analysis Cohort

n-5 from baseline early Parkinson's disease cohort

Interventions

DPA-714-PET/MRI

DPA-714-PET/MRI

5-year Follow-up DPA-714-PET/MRI

PET/MRI scan with DPA-714

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.

Primary outcome measure

  • Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls. [ Time Frame: 2 years ]
  • Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

UAB Advanced Imaging Facility

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-12.