NCT07064005 · Pravat Mandal
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
(PDGSH)
What this study is about
This study is designed l to evaluate the effects of GGC taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Gamma- glutamylcysteine
400 mg (two times) per day
Primary outcome measures
Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.
Time frame: 12 months
MEGA-PRESS is a non-invasive imaging technique, to detect various neurochemical (e.g., Glutathione) using 1H MR spectroscopy.
Changes in brain iron levels (ppb) in people with Parkinson's Disease using Magnetic Resonance Imaging between pre and post GGC supplementation.
Time frame: 12 months
Changes in baseline blood iron levels(ng/μl) in people with Parkinson's Disease
Time frame: 12 months
Changes in baseline blood glutathione levels (µmol/l) in people with Parkinson's Disease compared to post-supplementation with GGC
Time frame: 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Pittsburgh, Pennsylvania
Collaborators
Waste Connections Inc
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 4, 2026 · Source of record for eligibility and locations