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NCT01904240 · ClinicalTrials.gov registry record
Evaluation of a Biomarker Related to the GI Tract for the Diagnosis of Parkinson's Disease
A clinical trial, sponsored by Rush University Medical Center.
- Completed
- Registry status
- 200
- Enrollment target
NCT01904240: Completed study, sponsored by Rush University Medical Center.
NCT01904240 is a clinical trial that has completed, run by Rush University Medical Center. The registered enrollment target is 200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01904240 has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- 200 participants
- Enrollment target
Study Summary
The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed throughout the entire nervous system including the central, peripheral, and enteric nervous system. There is evidence that inflammation plays a major role in neurodegeneration in PD. In both the striatum and substantia nigra of PD patients activated microglia were found and proinflammatory cytokines (TNF, IL-1B, IL-6, iNOS) are increased in the CSF. An inflammation-driven animal model has emerged and has been widely accepted as a model of the disease based on lipopolysaccharide (LPS) induced neurotoxicity. LPS is an endotoxin found on the outer membrane of gram negative bacteria and humans are exposed to LPS through the intestinal tract. The intestinal tract and thus the enteric nervous system serve as a conduit to the central nervous system. It has been posited that the inflammatory process could gain access to the lower brainstem via the vagal nerve and then ascend through the basal mid- and forebrain until it reaches the cerebral cortex, producing various pre-motor and motor symptoms of PD along the way. LPS may be one of the inflammatory triggers involved in this process. Systemic exposure to bacterial endotoxin can be determined by measuring plasma LPS binding protein (LBP). A study of 9 patients with early PD (median Hoehn and Yahr stage 2) and age matched controls found that the PD subjects had a significantly lower mean level of plasma LBP compared to control subjects. The aim of the research plan is to establish LBP as a potential biomarker for PD across a spectrum of disease severity.
Primary Outcome
measure serum and plasma LBP levels in PD patients and control subjects
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-06 |
What the finished NCT01904240 record still lists
NCT01904240 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01904240 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01904240 about?
NCT01904240 is a clinical study titled "Evaluation of a Biomarker Related to the GI Tract for the Diagnosis of Parkinson's Disease". The cause of Parkinson's disease (PD) is currently unknown. Both environmental and genetic factors have been found to contribute to PD pathogenesis. The pathology of PD is distributed throughout the entire nervous system including the central, peripheral, and enteric nervous system. There is evidenc...
What is the current status of trial NCT01904240?
This trial is currently completed. The enrollment target is 200 participants. The study started on 2013-07. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT01904240?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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