What this study is
This study is designed l to evaluate the effects of GGC oral supplementation in early Parkinson's disease (PD) patients. The main objectives of the study are to evaluate:
1. To study the enrichment of master antioxidant, glutathione (GSH) levels in brain and blood of these PD patients compared to baseline due to GGC supplementation. 2. To study the changes in motor function, cognitive skills in PD patients due to GGC oral supplementation 3. To study impact of GGC on gut health on the PD patients.
What's being tested
- Gamma- glutamylcysteine
Intervention · DRUG
400 mg (two times) per day
Study details
- 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
- Sponsor
- Pravat Mandal
- Conditions
- Parkinsons Disease (PD)
- Enrolling
- 12 people
- Starts
- 2026-03-23
- Est. completion
- 2027-11-27
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years – 80 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
- Pravat K Mandal, PhD · Contact4126999561mandalpk@pitt.edu
Recruiting
Study team
Sponsor
Pravat Mandal
Study ID STUDY24120097
Principal investigator
Pravat K Mandal, PHD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.