Overview
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
Eligibility
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.