N-Acetyl Cysteine + FDOPA PET for Parkinson's Disease
(FdopaPD2 Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you need to be on stable Parkinson's medication for at least one month before joining. If you're taking medications that might interact with NAC, the study doctor will evaluate your situation individually.
What evidence supports the effectiveness of the treatment N-Acetyl Cysteine + FDOPA PET for Parkinson's Disease?
Research shows that FDOPA PET imaging can help visualize and measure the damage in the brain's dopamine system in Parkinson's disease, which is important for understanding disease progression. This imaging technique has been used to track how the disease progresses and to evaluate potential treatments.12345
Is N-Acetyl Cysteine safe for humans?
How does the drug N-acetyl cysteine differ from other treatments for Parkinson's disease?
N-acetyl cysteine (NAC) is unique because it acts as an antioxidant that may protect and support dopamine neurons, potentially improving dopamine function in the brain. Unlike standard treatments, NAC is administered both intravenously and orally, and it may offer neuroprotective benefits by increasing dopamine transporter binding, which is not a typical feature of other Parkinson's treatments.7891112
What is the purpose of this trial?
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.
Research Team
Daniel A Monti, MD, MBA
Principal Investigator
TJU, Dept. Chair: Integrative Medicine and Nutritional Sciences
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral and intravenous N-acetyl Cysteine (NAC) in addition to standard of care for Parkinson's Disease
Crossover
Participants switch arms; those initially receiving NAC switch to standard care and vice versa
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- [F-18] Fluorodopa Positron Emission Tomography
- N acetyl cysteine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Thomas Jefferson University
Lead Sponsor