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

NCT06289582 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-11

No results posted yet for this study

Summary

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

Conditions

  • Parkinson Disease

Interventions

DRUG

[F-18]DPA714 administration IV

brain PET/MRI imaging after \[F-18\]DPA-714 administration

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jonathan McConathy, MD, PhD · University of Alabama at Birmingham

  • David Standaert, MD, PhD · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2028-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289582 on ClinicalTrials.gov