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NCT04459052 · ClinicalTrials.gov registry record · Phase 2
FDOPA PET and Nutritional Support in Parkinson's Disease
A Phase 2 study of Parkinson Disease and Idiopathic Parkinson Disease, sponsored by Thomas Jefferson University.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04459052: Active Phase 2 study of Parkinson Disease and Idiopathic Parkinson Disease, sponsored by Thomas Jefferson University.
NCT04459052 is a Phase 2 study of Parkinson Disease and Idiopathic Parkinson Disease that is active but no longer recruiting, run by Thomas Jefferson University. The registered enrollment target is 50 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
NCT04459052, a Phase 2 study of Parkinson Disease and Idiopathic Parkinson Disease, is active but no longer recruiting, sponsored by Thomas Jefferson University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The overall goal of this study will be to further our understanding of how N Acetyl Cysteine (NAC) can help to support dopaminergic function in patients with Parkinson's disease (PD). We plan to use pre and post Positron emission tomography magnetic resonance imaging (PET-MRI) with \[F-18\] Fluorodopa (FDOPA) to measure dopamine function, and neurological measures to assess clinical symptoms, in patients with PD who are given oral capsules plus IV infusions of NAC in addition to standard of care for PD for 6 ±3 months in an open label cross over design. Serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, may be conducted.
Primary Outcome
To evaluate if intravenous/oral NAC helps to support dopamine function in the brain of patients with PD by using FDOPA PET imaging and subsequently helps to improve symptoms. Imaging will be conducted for standard of care and NAC arms.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT N acetyl cysteine
- DRUG [F-18] Fluorodopa Positron Emission Tomography
Study Locations (1)
Pennsylvania
- Thomas Jefferson University, Marcus Institute of Integrative Health Centers - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-04-30 |
| Est. Completion | 2027-01-08 |
| Phase | Phase 2 |
What the registry record for NCT04459052 still lists
NCT04459052 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 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 2 interventions - of which N acetyl cysteine is the first listed.
NCT04459052 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04459052 about?
NCT04459052 is a clinical study titled "FDOPA PET and Nutritional Support in Parkinson's Disease". The overall goal of this study will be to further our understanding of how N Acetyl Cysteine (NAC) can help to support dopaminergic function in patients with Parkinson's disease (PD). We plan to use pre and post Positron emission tomography magnetic resonance imaging (PET-MRI) with \[F-18\] Fluorodo...
What is the current status of trial NCT04459052?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2020-04-30. Estimated completion is 2027-01-08.
What conditions does trial NCT04459052 study?
This clinical trial studies the following conditions: Parkinson Disease, Idiopathic Parkinson Disease.
What interventions are being tested in trial NCT04459052?
The interventions under investigation include: N acetyl cysteine (DIETARY_SUPPLEMENT), [F-18] Fluorodopa Positron Emission Tomography (DRUG).
Who is sponsoring clinical trial NCT04459052?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04459052 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04459052's enrollment target sits among peer trials
50 155th of 297 higher than 135 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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