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TSPO-PET for Neuroinflammation in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03457493
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Jonathan E McConathy, University of Alabama at Birmingham

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 [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 or disease Intervention/treatment Phase
Parkinson Disease Drug: DPA-714-PET/MRI Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: UAB Neuroinflammation in Parkinson's Disease - TSPO-PET Substudy
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Comparison of TSPO-PET measures of neuroinflammation between PD patients and healthy controls. [ Time Frame: 2 years ]
    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.

  2. Correlation of DPA-714-PET/MRI with demographics, clinical and biospecimen assessments from Neuroinflammation in PD study [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457493


Contacts
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Contact: Jonathan McConathy, MD 205-996-7115 jmcconathy@uabmc.edu
Contact: April Riddle 205-934-6504 ariddle@uabmc.edu

Locations
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United States, Alabama
UAB Advanced Imaging Facility Recruiting
Birmingham, Alabama, United States, 35294
Contact: Marianne Vetrano, RN    205-934-4080    mvetrano@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jonathan McConathy, MD University of Alabama at Birmingham
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Responsible Party: Jonathan E McConathy, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03457493    
Other Study ID Numbers: IRB-300001025
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases