Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Purpose
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
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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 Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prodromal and manifest (PD) participants |
|
|
|
Experimental Healthy participants |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- University of Alabama at Birmingham