Increase brain and blood glutathione with gamma‑glutamylcysteine in early Parkinson's
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
This will test whether daily gamma‑glutamylcysteine supplements raise brain and blood glutathione and improve motor, thinking, and gut symptoms in people with early Parkinson's.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07064005 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study gives oral gamma‑glutamylcysteine (GGC) to people with early Parkinson's and measures biochemical and clinical changes before and after 12 months of supplementation. Brain glutathione will be measured noninvasively using MEGA‑PRESS MR spectroscopy, and blood glutathione and iron levels will be measured at baseline and after treatment. Motor function and neuropsychological testing will be performed pre- and post-supplementation, and gut microbiome measures will be compared to assess dysbiosis. The study aims to correlate changes in brain glutathione with motor performance and gut microbiome changes.
Who should consider this trial
Good fit: Ideal candidates are people aged 50–80 with a confirmed Parkinson's diagnosis, MoCA score ≥26, the ability to read and write English, and no dementia or major organ disease.
Not a fit: Patients with Parkinson's disease dementia or dementia with Lewy bodies, MRI‑incompatible implants or claustrophobia, significant kidney or liver disease, active psychosis, recent cancer, current antioxidant therapy or illicit drug dependence, or prior traumatic head injury are excluded and would not receive benefit from participation.
Why it matters
Potential benefit: If successful, GGC supplementation could raise antioxidant glutathione in the brain and blood and potentially improve motor, cognitive, and gut-related symptoms in early Parkinson's patients.
How similar studies have performed: GGC and other precursors have shown promising biochemical increases in glutathione in preclinical and small human studies, but clinical benefit in Parkinson's disease remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed Parkinson's Disease diagnosis. * Montreal Cognitive Assessment (MoCA) greater than or equal to 26. * Age (50 to 80 years of age). * Ability to read and write in English. Exclusion Criteria: * Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body. * Subjects with claustrophobia. * Patients with a clinical diagnosis of Parkinson's disease dementia or dementia with Lewy bodies. * Subjects with a history of cancer. * Subjects with active psychosis or delirium. * Subjects with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥ 1.5 ULN) within 30 days prior to enrolment. * Subjects on antioxidant therapy (ashwagandha, gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl). * Subjects with previous traumatic head injury.
Where this trial is running
Pittsburgh, Pennsylvania
- UPMC Presbyterian Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Pravat K Mandal, PHD — University of Pittsburgh
- Study coordinator: Pravat K MANDAL, PHD
- Email: mandalpk@pitt.edu
- Phone: 4126999561
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.