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ACTIVE NOT RECRUITING Phase 2

FDOPA PET and Nutritional Support in Parkinson's Disease

NCT04459052 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 50 participants
Start Date 2020-04-30
Est. Completion 2027-01-08
Phase Phase 2

Sponsor

Thomas Jefferson University

324 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04459052

The ClinicalTrials.gov registry entry for NCT04459052 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 324 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04459052 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04459052?

This trial is sponsored by Thomas Jefferson University, which has 324 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial