Trials / Recruiting
RecruitingNCT07064005
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Pravat Mandal · Academic / Other
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study will measure brain glutathione using non- invasive, state-of-the-art MEGA-PRESS pulse sequence in pre and post GGC supplementation after 12 months. The GSH level will also be measured in the blood in pre and post GGC supplementation. Brain and blood iron level will be measured in pre and post GGC supplementation. The neuropsychological examination and motor function will be performed in pre and post GGC supplementation. This study will provide the relation of brain GSH enrichment with motor performance. Our study will also provide any possible correlation with reduction of dysbiosis of the gut microbiome with GSH enrichment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gamma- glutamylcysteine | 400 mg (two times) per day |
Timeline
- Start date
- 2026-03-20
- Primary completion
- 2027-09-01
- Completion
- 2027-11-27
- First posted
- 2025-07-14
- Last updated
- 2026-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07064005. Inclusion in this directory is not an endorsement.