Parkinson Disease
Conditions
Brief summary
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
Interventions
DRUG[F-18]DPA714 administration IV
brain PET/MRI imaging after \[F-18\]DPA-714 administration
Sponsors
University of Alabama at Birmingham
Michael J. Fox Foundation for Parkinson's Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. | 24 months | The changes over time in neuroinflammation based on TSPO will be assessed by comparing TSPO-PET imaging at baseline, 12 months and 24 months after enrollment. |
Countries
United States
Contacts
CONTACTEvan Hudson
PRINCIPAL_INVESTIGATORJonathan McConathy, MD, PhD
University of Alabama at Birmingham
STUDY_DIRECTORDavid Standaert, MD, PhD
University of Alabama at Birmingham
Outcome results
None listed