Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT07064005
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
Sponsor:
Pravat Mandal
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PDGSH
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2001 | OTHER_GRANT | Waste Connections INC | View |