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

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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