RightFit
RecruitingPhase 1 / Phase 2

The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "UDALL Baseline Cohort) Participants eligible through enrollment in the UAB Neuroinflammation PD study will be consented for one-time DPA-714 PET/MRI imaging."
  • "Participants will receive follow-up DPA-714 PET/MRI imaging approximately 5 years after baseline imaging."
  • "Metabolite Analysis Cohort) Five PD participants eligible through enrollment in the UAB Neuroinflammation PD study will be consented for one-time DPA-714 PET/MRI imaging, arterial line placement and metabolite sampling."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET/MRI brain scans and a tracer called [18F]DPA-714 to measure inflammation in the brain. It compares people with Parkinson’s disease with healthy people to see if inflammation is higher in Parkinson’s disease. It is for adults age 30 or older who are enrolled in one of two related UAB studies.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 30 or older.
  • You must be enrolled in either UAB’s Innate and Adaptive Immunity in Parkinson Disease study or its Longitudinal [18F]DPA-714 Imaging in a Parkinson Disease Cohort study.
  • If you can become pregnant, you must have a negative pregnancy test within 2 days before the PET tracer is given. Testing is not needed if your last period was at least 1 year ago due to menopause or you have documented surgery to prevent pregnancy.
  • A gene test must show that the tracer can attach to its target protein at a high or mixed level.
  • For the UDALL 5-year follow-up group only: You must have Parkinson’s disease, be enrolled in the UDALL Baseline Cohort, and have had your first study scan no more than 6 years earlier.

Who can't join

  • You meet any rule that keeps you out of the related UAB studies.
  • You cannot safely have an MRI or PET scan.
  • Your Parkinson’s disease or another health condition is too severe for you to take part in the scans.
  • A gene test shows that the tracer attaches poorly to its target protein.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria for all cohorts: 1. 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) 2. 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. 3. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. Exclusion Criteria for all cohorts: 1. Meets any exclusion criteria for the UAB Innate and Adaptive Immunity in Parkinson's Disease (Clinical Research Core) study or UAB Longitudinal \[18F\]DPA-714 Imaging in a Parkinson's Disease Cohort 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. Inclusion Criteria specific for UDALL 5-year Follow-up Cohort 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.

Study sites (1)

AL