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NCT04459052Active, not recruitingPhase 2

FDOPA PET and Nutritional Support in Parkinson's Disease

Phase II: Physiological Effects of Nutritional Support in Patients With Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 29 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
50 (estimated)
First submitted
26 Jun 2020
Start date
30 Apr 2020
Primary completion date
11 Apr 2025
Lead sponsor
Thomas Jefferson University
NCT number
NCT04459052

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 50
  • From 30 Apr 2020 to the primary completion date, 11 Apr 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous brain surgery.
  • Patients with current alcohol or drug abuse
  • Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
  • Pending surgery during the course of the study.
  • Cancer patients receiving active chemotherapy.

Other illness

  • Known allergy to NAC
  • Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
  • Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
  • History of head trauma with loss of consciousness \> 48 hours.
  • Any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of parkinsonian syndrome symptoms, or with any of the study assessments including the PET-MRI imaging.
  • Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
  • History of thrombocytopenia or clotting disorders.
  • Severe gastroesophageal reflux disease.
  • History of uncontrolled diabetes, , gastroesophageal reflux disease, thyroid conditions
  • History of uncontrolled asthma.
  • Patients taking medications that might interact with NAC involved in this study will be evaluated on a case-by-case basis by the PI or study physician. These medications include: Medications for high blood pressure; Medications that slow blood clotting; Medications for diabetes; Nitroglycerin.

Lab values

  • History of severe kidney disease (if a patient reports this problem, a serum creatinine will be checked to assess glomerular filtration rate (GFR) and if it is less than 30, they will be excluded),

Other

  • Wheelchair-bound or bed-ridden, non-ambulatory.
  • Metal in the body that would prevent MRI scanning (as determined by the PI)
  • Pregnant or lactating women.

Who the study is looking for

  • Clinical diagnosis of PD
  • Age 30 years old and older
  • Physically independent, ambulatory
  • Hoehn and Yahr score of I-III inclusive.
  • On stable antiparkinsonian medication for at least one month
  • Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the period of pilot study. In addition, male subjects who have a partner of childbearing age should practice effective contraception.

Age in the registry: 30 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Thomas Jefferson University, Marcus Institute of Integrative Health Centers
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.