Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
Recruiting · NCT07064005 · Interventional (participants receive a specific treatment) · Lead sponsor: Pravat Mandal
View the official record on ClinicalTrials.gov →Interventions studied
Gamma- glutamylcysteine
What this trial is about
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.
Who can take part
Age range
50 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- UPMC Presbyterian Hospital - Pittsburgh, Pennsylvania, United States