Purpose

The primary objective of this substudy is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET (Positron Emission Tomography) ligand [18F]DPA-714 in participants enrolled in the UAB Neuroinflammation in PD study. 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 Neuroinflammation in PD study. 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.

Condition

Eligibility

Eligible Ages
Over 30 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  1. Enrollment in the UAB Neuroinflammation in PD study under the separate UAB approved research protocol IRB-300000690.
  2. Negative urine or serum hCG test within 2 days of [18F]DPA-714-PET administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.
  3. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.

Exclusion Criteria

  1. Meets any exclusion criteria for the UAB Neuroinflammation in PD study.
  2. Contraindication to MRI and/or PET imaging
  3. Inability to participate in the imaging studies due to severity of PD or other medical comorbidities.
  4. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. -

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Healthy Controls, DPA-714-PET/MRI
  • Drug: DPA-714-PET/MRI
    DPA-714-PET/MRI
Experimental
Early Parkinson's Disease, DPA-714-PET/MRI
  • Drug: DPA-714-PET/MRI
    DPA-714-PET/MRI

Recruiting Locations

UAB Advanced Imaging Facility
Birmingham, Alabama 35294
Contact:
Marianne Vetrano, RN
205-934-4080
mvetrano@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

Jonathan McConathy, MD
205-996-7115
jmcconathy@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.