Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
University of Alabama at Birmingham · with Michael J. Fox Foundation for Parkinson's Research · NCT06289582
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–99 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 60
- US sites recruiting
- 1
- Study start
- August 14, 2024
- Record last updated
- August 12, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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
Being studied: [F-18]DPA714 administration IV
Conditions: Parkinson Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
Recruiting US locations
UAB
Birmingham, AL 35294
Site contact: Evan Hudson, BS · 205-934-6499 · evanhudson@uabmc.edu
Study contacts (from the official record)
- Evan Hudson · 205-934-6499 · evanhusdon@uabmc.edu
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