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NCT02445651 · ClinicalTrials.gov registry record · NA
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
A NA study of Parkinson Disease and Idiopathic Parkinson Disease, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT02445651: Completed NA study of Parkinson Disease and Idiopathic Parkinson Disease, sponsored by Thomas Jefferson University.
NCT02445651 is a NA study of Parkinson Disease and Idiopathic Parkinson Disease that has completed, run by Thomas Jefferson University. The registered enrollment target is 51 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445651, a NA study of Parkinson Disease and Idiopathic Parkinson Disease, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more than a million Americans. It's most prominent pathology is the degeneration of dopaminergic neurons in the brain. It is believed that oxidative stress and inflammation play an important role in the pathophysiology of Parkinson's disease as well. The object of this study is to evaluate whether nutritional supplementation with oral and IV N acetyl cysteine compounds, that have been shown to have either anti- inflammatory, or antioxidant effects, might support brain function in patients with Parkinson's disease, particularly in regards to the dopamine system. Enrolled patients will be randomly assigned to receive oral and intravenous (IV) n-acetyl cysteine (NAC), a control group of standard PD care, or an oral supplement group who will receive Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin. (Please note, the Oral Supplements arm, was amended and not included in analysis. This study utilized Ioflupane (DaTscan) single photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD. Subjects received a DaTSCAN and MRS initially and after completing oral and IV NAC regimen. Subjects in the control group received pre and post DaTScans and MRS and similar evaluations to the Dietary Supplement oral and IV NAC group.
Primary Outcome
Distribution Volume Ratio reflects Iofluvane absorption by the dopamine transporters (Dopamine Uptake) that reflects binding in the dopamine transporter (DAT) overall. Striatal Binding Ratio in the regions of interest (ROI), caudate, putamen, and midbrain Serotonin Transporter (SERT) binding and Dopamine Transporter (5-HTT) Binding was measured during Single Photon Emission Computed Tomography (SPECT) Brain Imaging with DATScan (Iofluvane). Regions of interest in the caudate, putamen and in midb
Conditions Studied
Interventions
- OTHER Control group
- DIETARY_SUPPLEMENT Intravenous and Oral n-acetyl cysteine
- DIETARY_SUPPLEMENT Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin
Study Locations (1)
Pennsylvania
- Thomas Jefferson University - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2014-03 |
| Est. Completion | 2022-08-04 |
| Phase | NA |
What the finished NCT02445651 record still lists
NCT02445651 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which Control group is the first listed.
NCT02445651 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02445651 about?
NCT02445651 is a clinical study titled "Physiological Effects of Nutritional Support in Patients With Parkinson's Disease". Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more than a million Americans. It's most prominent pathology is the degeneration of dopaminergic neurons in the brain. It is believed that oxidative stress and inflammation play an important role in the pathophysi...
What is the current status of trial NCT02445651?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2014-03. Estimated completion is 2022-08-04.
What conditions does trial NCT02445651 study?
This clinical trial studies the following conditions: Parkinson Disease, Idiopathic Parkinson Disease.
What interventions are being tested in trial NCT02445651?
The interventions under investigation include: Control group (OTHER), Intravenous and Oral n-acetyl cysteine (DIETARY_SUPPLEMENT), Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT02445651?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02445651 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02445651's enrollment target sits among peer trials
51 153rd of 297 higher than 144 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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