Gamma- glutamylcysteine for Parkinson's (NCT07064005)
Reduce movement problems with supplement
- Trial ID
- NCT07064005
- Official Title
- Brain Glutathione (GSH) Enrichment Through Gamma-glutamylcysteine (GGC) Supplementation in Early Parkinson's Disease Patients for Reduction of Extrapyramidal Motor Disturbances and Halting Cognition Decline: A Pilot Trial
- Goal
- Reduce movement problems with supplement
- Phase
- PHASE1
- Status
- RECRUITING
- Sponsor
- Pravat Mandal
- Study Type
- INTERVENTIONAL
- Enrollment
- 12 participants
- Conditions
- Parkinsons Disease (PD)
- Interventions
- Gamma- glutamylcysteine
Summary For Families
The goal is to see whether boosting brain glutathione can reduce Parkinson's extrapyramidal movement problems and help prevent early thinking decline. In a Phase 1 pilot, participants take gamma-glutamylcysteine, the direct building block the body uses to make glutathione, with the idea that higher antioxidant levels in the brain will protect dopamine neurons from oxidative damage; it is intended as an add-on not a replacement for levodopa, and no specific interactions with levodopa are expected. The trial will enroll 12 people aged 50 to 80 with confirmed Parkinson's and normal cognition on the MoCA (score ≥ 26), who can read and write English. People with metal implants or claustrophobia, dementia, active psychosis, recent serious liver or kidney disease, current antioxidant supplements, recent head injury, cancer, or substance abuse are excluded.
Locations
- UPMC Presbyterian Hospital, Pittsburgh, Pennsylvania, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Gamma- glutamylcysteine. The goal is to see whether boosting brain glutathione can reduce Parkinson's extrapyramidal movement problems and help prevent early thinking decline. In a Phase 1 pilot, participants take gamma-glutamylcysteine, the direct building block the body uses to make glutathione, with the idea that higher antioxidant levels in the brain will protect dopamine neurons from oxidative damage; it is intended as an add-on not a replacement for levodopa, and no specific interactions with levodopa are expected. The trial will enroll 12 people aged 50 to 80 with confirmed Parkinson's and normal cognition on the MoCA (score ≥ 26), who can read and write English. People with metal implants or claustrophobia, dementia, active psychosis, recent serious liver or kidney disease, current antioxidant supplements, recent head injury, cancer, or substance abuse are excluded.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 1 trial is estimated to last approximately 1 year and 5 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.