Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

The overall goal of this protocol is to investigate [18F]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in [18F]DPA-714 binding in PD participants during a 24-month interval.

Primary Objectives

• To compare [18F]DPA-714 binding in prodromal and manifest PD and healthy volunteers.
• To determine the longitudinal change in [18F]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants.

Secondary Objectives

• To evaluate the correlation between baseline [18F]DPA-714 and PPMI clinical and biomarker outcomes.
• To evaluate the correlation between the longitudinal change of [18F]DPA-714 and PPMI clinical and biomarker outcomes
• To acquire safety data following injection of [18F]DPA-714

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Drug: [F-18]DPA714 administration IV

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Evan Hudson; Phone Number: 205-934-6499; Email: evanhusdon@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • UAB
      • Contact: Evan Hudson, BS; Phone Number: 205-934-6499; Email: evanhudson@uabmc.edu
      • Principal Investigator: Jonathan McConathy, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol
• A PD participant enrolled in PPMI Clinical protocol who has not started symptomatic treatment at time of enrollment or in the first 2 years of participation.
• Able to provide informed consent
• Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)

• Male or Female (Females must meet additional criteria specified below, as applicable)

  • Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of [18F]DPA-714

• Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).

• Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.

  • Females of childbearing potential must not be pregnant, breastfeeding or lactating.
  • Includes a negative urine pregnancy test prior to injection of [18F]DPA-714 on day of PET scan.

Exclusion Criteria:

• Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations , during the past year.
• Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy participants	Drug: [F-18]DPA714 administration IV; brain PET/MRI imaging after [F-18]DPA-714 administration
Experimental: Prodromal and manifest (PD) participants	Drug: [F-18]DPA714 administration IV; brain PET/MRI imaging after [F-18]DPA-714 administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.	The changes over time in neuroinflammation based on TSPO will be assessed by comparing TSPO-PET imaging at baseline, 12 months and 24 months after enrollment.	24 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Michael J. Fox Foundation for Parkinson's Research
• Investigators: Principal Investigator: Jonathan McConathy, MD, PhD, University of Alabama at Birmingham; Study Director: David Standaert, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: IRB-300012051 R24-004; 022189 (Other Grant/Funding Number: Fox (Michael J.) Foundation for Parkinson's Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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