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FDOPA PET and Nutritional Support in Parkinson's Disease

Study acronym: FdopaPD2
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary completion date changed from estimate of May 1, 2025 to Apr 11, 2025
    • Study completion date: May 1, 2025 to Jan 8, 2027
    v8
  2. Primary and study completion dates: May 1, 2024 to May 1, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Trial status: Active, Not Recruiting to Recruitingv5 Show 5 more changesShow less
    • Primary and study completion dates: May 1, 2023 to May 1, 2024
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised
    • Eligibility criteria shortened, about 1 word
  5. Study title shortened, about 2 wordsv4
Show 2 earlier versionsHide 2 earlier versions
  1. Study description expanded, about 4 words
    • Study title expanded, about 2 words
    v3
  2. Study description shortened, about 30 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04459052
Lead Sponsor Thomas Jefferson University
Conditions
(from sponsor)		 Parkinson Disease, Idiopathic Parkinson Disease
Related terms Central Nervous System Diseases, Movement Disorders, Neurodegenerative Diseases, Parkinson Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov