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Dietary Supplement

N-Acetyl Cysteine + FDOPA PET for Parkinson's Disease (FdopaPD2 Trial)

Phase 2

Waitlist Available

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 30 years old and older

Hoehn and Yahr score of I-III inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months ± 3 months

Awards & highlights

FdopaPD2 Trial Summary

This trial will study how well N-Acetyl Cysteine works in patients with Parkinson's disease by measuring dopamine function and clinical symptoms.

Who is the study for?

This trial is for Parkinson's Disease patients aged 30+, on stable medication, with a Hoehn and Yahr score of I-III. They must be physically independent and not pregnant or planning surgery. Exclusions include allergies to NAC, previous brain surgeries, severe cognitive impairment, non-ambulatory status, significant psychiatric disorders, substance abuse issues, recent participation in other trials or therapies.Check my eligibility

What is being tested?

The study tests how N Acetyl Cysteine (NAC) supports dopamine function in Parkinson's patients using PET-MRI scans before and after treatment. Participants will receive oral capsules plus IV infusions of NAC alongside standard care over approximately six months in an open-label crossover design.See study design

What are the potential side effects?

Potential side effects from NAC may include allergic reactions for those sensitive to it. Since the trial includes imaging procedures like PET-MRI scans, there might be risks associated with exposure to radiation and contrast agents used during these scans.

FdopaPD2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 years old or older.

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My Parkinson's disease is in the early to mid-stage.

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I have been diagnosed with Parkinson's disease.

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I can walk and move around on my own.

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My Parkinson's disease is in the early to mid-stage.

FdopaPD2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months ± 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months ± 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months ± 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

FDOPA PET

Secondary outcome measures

Magnetic Resonance Spectroscopy (MRS)

Other outcome measures

Beck Depression Inventory

Blood Draw

Parkinson's Disease Questionnaire-39.

+2 more

FdopaPD2 Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlist Control CohortExperimental Treatment1 Intervention

Standard of Care Treatment for approximately 6 ±3 months.

Group II: Oral and IV N acetyl Cysteine CohortExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

N acetyl cysteine

2011

Completed Phase 4

~30

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

444 Previous Clinical Trials

145,594 Total Patients Enrolled

Daniel A Monti, MD, MBAStudy ChairTJU, Dept. Chair: Integrative Medicine and Nutritional Sciences

2 Previous Clinical Trials

60 Total Patients Enrolled

Media Library

N acetyl cysteine (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04459052 — Phase 2

Parkinson's Disease Research Study Groups: Oral and IV N acetyl Cysteine Cohort, Waitlist Control Cohort

Parkinson's Disease Clinical Trial 2023: N acetyl cysteine Highlights & Side Effects. Trial Name: NCT04459052 — Phase 2

N acetyl cysteine (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04459052 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this medication received regulatory approval from the FDA?

"This is a Phase 2 trial, which means that while there is some evidence supporting the safety of this treatment, there is none yet to suggest that it effective. Our team scores it as a 2."

Answered by AI

Are there any open positions for participants in this clinical trial?

"Yes, this study is still open and recruiting patients. According to clinicaltrials.gov, the trial was originally posted on April 30th, 2020 and updated on July 25th, 2022."

Answered by AI

How many individuals have been recruited to participate in this research project?

"That is correct, the clinical trial mentioned is currently recruiting patients. It was first posted on 4/30/2020 and last updated on 7/25/2022. The aim is to find 50 willing participants at a single location."

Answered by AI