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

NCT06289582 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: R24-004022189
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Prodromal and manifest (PD) participants

EXPERIMENTAL

Drug: [F-18]DPA714 administration IV

Healthy participants

EXPERIMENTAL

Drug: [F-18]DPA714 administration IV

Interventions

[F-18]DPA714 administration IV DRUG

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

Healthy participants; Prodromal and manifest (PD) participants

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Michael J. Fox Foundation for Parkinson's Research: collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jonathan McConathy, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• David Standaert, MD, PhD

  University of Alabama at Birmingham

  STUDY DIRECTOR

Central Study Contacts

Evan Hudson

CONTACT

205-934-6499; evanhusdon@uabmc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. P.h.D., Director for the Division Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 4, 2024
• Study Start: August 14, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)