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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT03457493
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • DPA-714-PET/MRI — DRUG
    DPA-714-PET/MRI
  • 5-year Follow-up DPA-714-PET/MRI — DRUG
    PET/MRI scan with DPA-714
  • DPA-714 Metabolite Analysis — DRUG
    Participants will have an arterial line placed in their lower forearm immediately before DPA-714 PET/MRI. Serial blood samples will be pulled at specific time points during the dynamic PET/MRI.

Study Details

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.

Key Dates

First listed
Mar 7, 2018
Start date
Mar 22, 2018
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
205 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UAB Advanced Imaging FacilityBirminghamAlabama35294
Evan Hudson
[email protected]
205-996-1082

Find similar trials in Birmingham, AL

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
UAB Advanced Imaging Facility· Birmingham, AL

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