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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Alabama at Birmingham

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • [F-18]DPA714 administration IV

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

Michael J. Fox Foundation for Parkinson's Research

Collaborator