search
Back to results

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

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DPA-714-PET/MRI
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Enrollment in the UAB Neuroinflammation in PD study under the separate UAB approved research protocol Institutional Review Board number (IRB)-300000690.
  2. Negative urine or serum Human chorionic gonadotropin (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. -

Sites / Locations

  • UAB Advanced Imaging FacilityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy Controls, DPA-714-PET/MRI

Early Parkinson's Disease, DPA-714-PET/MRI

Arm Description

Outcomes

Primary Outcome Measures

Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls.
Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. TSPO-PET measures will be compared between PD patients and healthy controls. We expect the PD patients to have higher measures of neuroinflammation than healthy controls.
Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study
The estimates of neuroinflammation measured with TSPO-PET will be correlated with clinical assessments of PD severity and biospecimens collected through the UAB Neuroinflammation in PD study.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2018
Last Updated
February 7, 2023
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT03457493
Brief Title
The University of Alabama at Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
Official Title
UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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 (Positron Emission Tomography) ligand Fluorodeoxyglucose dimethylpyrazolo ([18F]DPA-714) in participants enrolled in the UAB Neuroinflammation in Parkinsons Disease (PD) study. The PET tracer [18F]DPA-714 binds to the 18 kilodaltons (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls, DPA-714-PET/MRI
Arm Type
Experimental
Arm Title
Early Parkinson's Disease, DPA-714-PET/MRI
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DPA-714-PET/MRI
Intervention Description
DPA-714-PET/MRI
Primary Outcome Measure Information:
Title
Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls.
Description
Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. TSPO-PET measures will be compared between PD patients and healthy controls. We expect the PD patients to have higher measures of neuroinflammation than healthy controls.
Time Frame
2 years
Title
Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study
Description
The estimates of neuroinflammation measured with TSPO-PET will be correlated with clinical assessments of PD severity and biospecimens collected through the UAB Neuroinflammation in PD study.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Enrollment in the UAB Neuroinflammation in PD study under the separate UAB approved research protocol Institutional Review Board number (IRB)-300000690. Negative urine or serum Human chorionic gonadotropin (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. High or mixed affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971. Exclusion Criteria: Meets any exclusion criteria for the UAB Neuroinflammation in PD study. Contraindication to MRI and/or PET imaging Inability to participate in the imaging studies due to severity of PD or other medical comorbidities. Low affinity binder for TSPO ligands based on genotyping for SNP rs6971. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan McConathy, MD
Phone
205-996-7115
Email
jmcconathy@uabmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
April Riddle
Phone
205-934-6504
Email
ariddle@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Advanced Imaging Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Vetrano, RN
Phone
205-934-4080
Email
mvetrano@uabmc.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs