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

NCT ID: NCT06289582

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-14
• Study Completion Date: 2028-06-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Prodromal and manifest (PD) participants

Group Type: EXPERIMENTAL

[F-18]DPA714 administration IV

Intervention Type: DRUG

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

Healthy participants

Group Type: EXPERIMENTAL

[F-18]DPA714 administration IV

Intervention Type: DRUG

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

Interventions

[F-18]DPA714 administration IV

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jonathan E McConathy

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan McConathy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

David Standaert, MD, PhD

Role: STUDY_DIRECTOR

University of Alabama at Birmingham

Locations

UAB

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Evan Hudson

Role: CONTACT

evanhusdon@uabmc.edu

205-934-6499

Facility Contacts

Evan Hudson, BS

Role: primary

evanhudson@uabmc.edu

205-934-6499

Other Identifiers

022189

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

R24-004

Identifier Type: -

Identifier Source: org_study_id