UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy

Who is this study for? Patients with Parkinson's disease
What treatments are being studied? DPA-714-PET/MRI
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

The primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET ligand \[18F\]DPA-714 in participants enrolled in the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The PET tracer \[18F\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The amount and distribution of \[18F\]DPA-714 in the brain will be correlated to clinical data acquired through the separate ongoing UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) and Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort studies. The primary objective of this study is to determine if patients with PD have higher levels of neuroinflammation than healthy controls as measured with \[18F\]DPA-714-PET/MRI.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Healthy Volunteers: t
View:

• Enrollment in either the UAB Innate and Adaptive Immunity in Parkinson Disease (Clinical Research Core) study or UAB Longitudinal \[18F\]DPA-714 Imaging in a Parkinson Disease Cohort study under the separate UAB-approved research protocols (IRB-300001745 and IRB-300011684 respectively, PI Yacoubian)

• Negative urine or serum Human chorionic gonadotropin (hCG) test within 2 days of \[18F\]DPA-714-PET administration in women of childbearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

• High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.

⁃ 1\. Parkinson's Disease participant enrolled in UDALL Baseline Cohort. Baseline imaging to be completed no more than 6 years prior.

⁃ Inclusion of Women and Minorities

⁃ Participants 30 years of age or older will be eligible for study participation. No other discriminatory factors, including age, sex, or ethnic background will be used to determine eligibility. Every effort will be made to ensure that minorities are recruited for study participation.

Locations
United States
Alabama
UAB Advanced Imaging Facility
RECRUITING
Birmingham
Contact Information
Primary
Jonathan McConathy, MD
jmcconathy@uabmc.edu
205-996-7115
Backup
Evan Hudson
evanhudson@uabmc.edu
205-996-1082
Time Frame
Start Date: 2018-03-22
Estimated Completion Date: 2027-06
Participants
Target number of participants: 205
Treatments
Experimental: Baseline Cohort Healthy Controls, DPA-714-PET/MRI
n-105
Experimental: Baseline Cohort Early Parkinson's Disease, DPA-714-PET/MRI
n-100
Experimental: UDALL 5-year Follow-up Cohort
n-67 from baseline early Parkinson's disease cohort
Experimental: Metabolite Analysis Cohort
n-5 from baseline early Parkinson's disease cohort
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov