FDOPA PET and Nutritional Support in Parkinson's Disease

NCT04459052 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20D.408
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Idiopathic Parkinson Disease

Keywords

Alternative Medicine; Complementary Medicine; Parkinson's disease; Neurodegenerative Diseases; Idiopathic Parkinson's disease; Central Nervous System Diseases; Movement Disorders; N acetyl cysteine; [F-18] Fluorodopa; magnetic resonance spectroscopy; PET; positron emission tomography; dopaminergic function

Outcome Measures

Primary Outcomes (2)

• FDOPA PET

  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.

  Change from Baseline at approximately 6 months ± 3 months to access changes in Dopaminergic Function.

• FDOPA PET

  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.

  Change from Baseline at approximately 12 months ± 3 months months to access changes in Dopaminergic Function.

Secondary Outcomes (2)

• Magnetic Resonance Spectroscopy (MRS)

  Change from Baseline at approximately 6 months ± 3 months to access changes in oxidative stress and metabolism..

• Magnetic Resonance Spectroscopy (MRS)

  Change from Baseline at approximately 12 months ± 3 months to access changes in oxidative stress and metabolism..

Other Outcomes (9)

• Blood Draw

  .Change from Baseline NAC at approximately 6 months ± 3 months to assess serum concentration analysis of NAC.

• Unified Parkinson's Disease Rating Scale or Movement Disorders Scale

  Change from Baseline at approximately 6 months ± 3 months to access changes in PD symptoms.

• Unified Parkinson's Disease Rating Scale or Movement Disorders Scale

  Change from Baseline at approximately 12 months to access changes in PD symptoms.

Study Arms (2)

Oral and IV N acetyl Cysteine Cohort

OTHER

Administration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered). Oral NAC will be taken for approximately 6 ±3 months.

Dietary Supplement: N acetyl cysteine; Drug: [F-18] Fluorodopa Positron Emission Tomography

Waitlist Control Cohort

OTHER

Standard of Care Treatment for approximately 6 ±3 months.

Drug: [F-18] Fluorodopa Positron Emission Tomography

Interventions

N acetyl cysteine DIETARY_SUPPLEMENT

Intervention: IV NAC infusion: Dose: 50mg in 200ml of Dextrose 5% in Water (D5W), frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 500 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)

Also known as: NAC

Oral and IV N acetyl Cysteine Cohort

[F-18] Fluorodopa Positron Emission Tomography DRUG

FDOPA PET diagnostic imaging to to measure dopamine function, serum measures of NAC concentrations, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, 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 months.

Also known as: FDOPA PET/MRI

Oral and IV N acetyl Cysteine Cohort; Waitlist Control Cohort

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to NAC
• Previous brain surgery.
• Cognitive impairment by evaluation or known score on Mini-Mental Status examination of 25 or lower.
• Wheelchair-bound or bed-ridden, non-ambulatory.
• 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.
• Metal in the body that would prevent MRI scanning (as determined by the PI)
• Patients with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate.
• Patients with current alcohol or drug abuse
• Pregnant or lactating women.
• Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
• Pending surgery during the course of the study.
• History of thrombocytopenia or clotting disorders.
• Cancer patients receiving active chemotherapy.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University, Marcus Institute of Integrative Health Centers

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.

  PMID: 27309537 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases; Central Nervous System Diseases; Movement Disorders

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Nervous System Diseases; Synucleinopathies

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Daniel A Monti, MD, MBA

  TJU, Dept. Chair: Integrative Medicine and Nutritional Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an Open Label study. Randomization will occur via a 1:1 ratio of the NAC group and the waitlist control groups using the method of random permuted blocks with random block sizes without stratification.

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: July 7, 2020
• Study Start: April 30, 2020
• Primary Completion: April 11, 2025
• Study Completion (Estimated): January 8, 2027
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Study scan report will be offered to the subject after subject completes study
• Access Criteria: Access only to authorized research staff and study participants

Locations

US (1)