What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, such as cholinesterase inhibitors (e.g., rivastigmine and donepezil), often result in side effects like worsened tremor, nausea, and vomiting. NAC, which is being studied for its potential to support dopaminergic function by reducing oxidative stress and inflammation, has shown promise in animal studies for restoring depleted dopamine levels and protecting against neurotoxicity. However, specific side effects of NAC in PD patients are not well-documented. Other treatments for PD, such as levodopa, can cause dyskinesia, motor fluctuations, and psychiatric symptoms. It is important to monitor for these side effects and adjust treatment as necessary.

What prior FDA approvals exist?

FDA-approved treatments for Parkinson's Disease that focus on supporting dopaminergic function and reducing oxidative stress and inflammation include medications like Levodopa, which is often combined with Carbidopa to enhance its efficacy and reduce side effects. Additionally, MAO-B inhibitors such as Selegiline and Rasagiline help to prevent the breakdown of dopamine in the brain, thereby increasing its availability. While N-Acetyl Cysteine (NAC) is being studied for its potential to support dopaminergic function by reducing oxidative stress and inflammation, it is not yet FDA-approved for this purpose. Other treatments like antioxidants and anti-inflammatory agents are still under investigation for their potential benefits in PD.

What other types of research exist?

Promising alternatives to N-Acetyl Cysteine (NAC) for Parkinson's Disease patients include: 1) Curcumin nanoemulsion, which has shown enhanced neuroprotective effects and prevention of motor impairment in experimental models. 2) Sulforaphane, derived from broccoli, which has demonstrated potential benefits in neurodevelopmental disorders and may offer neuroprotective effects. 3) Transcranial Magnetic Stimulation (TMS), which has shown promise in modulating brain activity and reducing symptoms in neurodevelopmental and neurodegenerative disorders.

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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

Must not have

History of uncontrolled diabetes, gastroesophageal reflux disease, thyroid conditions

Cancer patients receiving active chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months ± 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if NAC, a cell-protecting supplement, can help people with Parkinson's disease by improving their dopamine function. NAC boosts a protective substance in the brain, potentially keeping dopamine-producing cells healthy. NAC has been studied for its potential to support dopamine neurons and improve motor function in Parkinson's disease due to its antioxidant properties.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have controlled diabetes, GERD, or thyroid conditions.

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I am currently undergoing chemotherapy for cancer.

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I have severe kidney disease with a GFR less than 30.

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I have asthma that is not well-controlled.

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I have severe acid reflux.

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I have had a head injury that made me unconscious for more than 48 hours.

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I don't have any health issues that could affect Parkinson's disease symptom evaluation or PET-MRI scans.

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I have had brain surgery before.

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I am scheduled for surgery during the study period.

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I cannot walk and use a wheelchair or stay in bed.

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I have a history of low platelet counts or clotting disorders.

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I don't have brain conditions that could affect scan readings.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

FDOPA PET

Secondary study objectives

Magnetic Resonance Spectroscopy (MRS)

Other study objectives

Beck Depression Inventory

Blood Draw

Parkinson's Disease Questionnaire-39.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include N-Acetyl Cysteine (NAC), which supports dopaminergic function by reducing oxidative stress and inflammation, crucial factors in PD neurodegeneration. Levodopa, another primary treatment, replenishes dopamine levels in the brain, directly addressing the dopamine deficiency that characterizes PD. MAO-B inhibitors prevent the breakdown of dopamine, thereby prolonging its action. These treatments are vital for PD patients as they help manage symptoms, improve quality of life, and potentially slow disease progression by targeting the underlying mechanisms of neurodegeneration.

Novel anti-apoptotic L-DOPA precursors SuperDopa and SuperDopamide as potential neuroprotective agents for halting/delaying progression of Parkinson's disease.N-acetylcysteine prevents rotenone-induced Parkinson's disease in rat: An investigation into the interaction of parkin and Drp1 proteins.