Recruiting
Early Phase 1

DPA-714

Sponsor:

University of Alabama at Birmingham

Code:

NCT06289582

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

[F-18]DPA714 administration IV

Study Details

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 ID

NCT06289582

Start date

Aug 14, 2024

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Prodromal and manifest (PD) participants

experimental: Healthy participants

Interventions

[F-18]DPA714 administration IV

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

Primary outcome measure

  • Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Evan Hudson

205-934-6499evanhusdon@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Evan Hudson, BS

205-934-6499evanhudson@uabmc.edu

Principal Investigator:

Jonathan McConathy, MD,PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-12.