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NCT06289582RecruitingEarly phase 1

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

Source: ClinicalTrials.gov · Last updated 12 Aug 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
60 (estimated)
First submitted
13 Feb 2024
Start date
14 Aug 2024
Primary completion date
Jun 2028
Lead sponsor
University of Alabama at Birmingham
NCT number
NCT06289582

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 60
  • From 14 Aug 2024 to the primary completion date, Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UAB
Coordinator of this site? Confirm its status
BirminghamUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.