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

University of Alabama at Birmingham1 site in 1 country60 target enrollmentAugust 14, 2024

ConditionsParkinson Disease

Interventions[F-18]DPA714 administration IV

Drugs[F-18]DPA714 administration IV

Overview

Phase: Early Phase 1
Intervention: [F-18]DPA714 administration IV
Conditions: Parkinson Disease
Sponsor: University of Alabama at Birmingham
Enrollment: 60
Locations: 1
Primary Endpoint: Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

August 14, 2024

End Date

June 1, 2028

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Jonathan E McConathy

M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

University of Alabama at Birmingham

Eligibility Criteria

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.

Arms & Interventions

Prodromal and manifest (PD) participants

Intervention: [F-18]DPA714 administration IV

Healthy participants

Intervention: [F-18]DPA714 administration IV

Outcomes

Primary Outcomes

Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.

Time Frame: 24 months

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.