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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 belowSelect...
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
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 moreFdopaPD2 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
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,628 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have controlled diabetes, GERD, or thyroid conditions.I have had brain surgery before.I am currently undergoing chemotherapy for cancer.I am 30 years old or older.I have severe kidney disease with a GFR less than 30.My Parkinson's disease is in the early to mid-stage.I have asthma that is not well-controlled.I have severe acid reflux.I have had a head injury that made me unconscious for more than 48 hours.I don't have any health issues that could affect Parkinson's disease symptom evaluation or PET-MRI scans.You have metal in your body that would stop you from getting an MRI scan.I am using effective birth control as my partner can have children.I am scheduled for surgery during the study period.I have been on steady Parkinson's medication for over a month.I am not pregnant and will use effective birth control during the study.I have been diagnosed with Parkinson's disease.I cannot walk and use a wheelchair or stay in bed.I can walk and move around on my own.You have difficulty thinking and remembering, or you scored 25 or lower on a memory test.I have a history of low platelet counts or clotting disorders.I am taking medication that could interact with the study drug.I don't have brain conditions that could affect scan readings.My Parkinson's disease is in the early to mid-stage.I am using or willing to use effective birth control during the study.You are allergic to N-acetylcysteine (NAC).You are currently struggling with alcohol or drug abuse.
Research Study Groups:
This trial has the following groups:- Group 1: Oral and IV N acetyl Cysteine Cohort
- Group 2: Waitlist Control Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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