Investigating brain imaging in early Parkinson's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the binding of the radiotracer [18F]DPA-714 in individuals with prodromal and early manifest Parkinson's Disease (PD) over a 24-month period. It will compare the binding levels between PD participants and healthy volunteers, while also assessing changes in binding over time. Additionally, the study will evaluate correlations between imaging results and clinical outcomes, as well as gather safety data related to the administration of [18F]DPA-714.

Why it matters

Who can join: the full rules

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.

Where it's running

• UAB
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Jonathan McConathy, MD, PhD — University of Alabama at Birmingham
• Study coordinator: Evan Hudson
• Email: evanhusdon@uabmc.edu
• Phone: 205-934-6499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.