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NCT05419453 · ClinicalTrials.gov registry record
Microbiome Composition and Function Contributes to Cognitive Impairment and Neuroinflammation in Parkinson's Disease
A clinical trial of Parkinson Disease, sponsored by California State University, San Bernardino.
- Recruiting
- Registry status
- 100
- Enrollment target
- 1
- Study location
NCT05419453 is a study of Parkinson Disease that is actively recruiting participants, run by California State University, San Bernardino. The registered enrollment target is 100 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05419453, a study of Parkinson Disease, is actively recruiting participants, sponsored by California State University, San Bernardino.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Cognitive impairment is a common non-motor symptom among individuals living with Parkinson's disease (PD). Traditionally, cognitive impairment is thought to reflect disruptions in dopaminergic frontal-striatal systems. However, the current conceptualization does not thoroughly explain the heterogeneous profiles or trajectories of cognitive impairment in PD; suggesting that alternative mechanisms may contribute to cognitive impairments. Identification of alternative mechanisms of cognitive impairment may lead to better prognostic prediction and yield novel treatment targets. The gut is implicated as a site of early pathology in PD. Early signs of PD pathology (alpha synuclein and Lewy body aggregates) are detected in the gastrointestinal tract years before motor symptoms manifest. Recent studies provide evidence that individuals with PD have an altered gut-bacterial composition (termed dysbiosis) relative to controls. To date, dysbiosis is linked to more severe motor symptoms and certain non-motor symptoms (constipation, REM behavioral sleep disorder) in PD, but the relationship between dysbiosis and cognitive impairment remains unknown. Animal studies support the hypothesis that microbiota composition play a direct role in cognitive impairment. Germ free (GF) mice demonstrate deficits in cognition. Specifically, findings suggest that a disrupted gut- microbial environment in conjunction with elevated stress hormones may create an imbalance of pro- inflammatory vs. anti-inflammatory cytokines that induces potentially reversible cognitive impairments. In human studies among individuals with PD, neuroinflammatory markers are associated with cognitive impairment. However, the relationship between dysbiosis, neural inflammation and cognitive functioning remains unknown. This model has incredible clinical implications, as microbiota dysbiosis may represent a reversible risk factor for cognitive impairment. The proposed study will examine the hypothesis that dysbiosis cont
Conditions Studied
Study Locations (1)
California
- California State University San Bernardino - San Bernardino
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2026-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05419453
The ClinicalTrials.gov registry entry for NCT05419453 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (98% lower). The listed sponsor is California State University, San Bernardino, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Parkinson Disease appearing as the primary indexed condition, and to 0 interventions.
NCT05419453 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05419453 about?
NCT05419453 is a clinical study titled "Microbiome Composition and Function Contributes to Cognitive Impairment and Neuroinflammation in Parkinson's Disease". Cognitive impairment is a common non-motor symptom among individuals living with Parkinson's disease (PD). Traditionally, cognitive impairment is thought to reflect disruptions in dopaminergic frontal-striatal systems. However, the current conceptualization does not thoroughly explain the heterogene...
What is the current status of trial NCT05419453?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2021-04-30. Estimated completion is 2026-04.
What conditions does trial NCT05419453 study?
This clinical trial studies the following conditions: Parkinson Disease.
Who is sponsoring clinical trial NCT05419453?
This trial is sponsored by California State University, San Bernardino, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05419453 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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