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RecruitingEarly Phase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET scans to see how an injected tracer called [18F]DPA-714 attaches in the body and changes over 24 months. It is for people in PPMI with early signs of Parkinson’s disease, early diagnosed Parkinson’s disease, or no Parkinson’s disease. The study also checks the tracer’s safety.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be enrolled in the PPMI Clinical study as a healthy participant or someone with early signs of Parkinson’s disease or diagnosed Parkinson’s disease.
  • If you have diagnosed Parkinson’s disease, you must not have started medicine to treat symptoms at enrollment or during your first 2 years of participation.
  • Be able to understand the study and agree to join.
  • Have a screening gene test showing you are a “high binder” for the TSPO gene change rs6971. This means the tracer attaches strongly.
  • Women must be unable to become pregnant or use highly effective birth control from 14 days before until at least 24 hours after the tracer injection.
  • Being unable to become pregnant means having no periods for at least 12 months before the scan, or having surgery to tie both tubes or remove both ovaries or the uterus.
  • Allowed birth control includes pills started at least 3 months before injection, an IUD placed at least 2 months before injection, or barrier methods such as a diaphragm or condoms with sperm-killing gel. Avoiding sex only on fertile days is not allowed.
  • Women who can become pregnant must not be pregnant or breastfeeding and must have a negative urine pregnancy test before the injection on scan day.

Who can't join

  • Have had a total whole-body radiation dose of 50 millisieverts (mSv) during the past year. This is the yearly limit set by U.S. rules.
  • Have another medical or mental health condition, or an unusual lab result, that the study doctor believes would prevent you from joining.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

AL