RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests gamma-glutamylcysteine (GGC), a supplement taken by mouth, in adults ages 50 to 80 with early Parkinson's disease. It looks at whether GGC raises glutathione, a substance that helps protect cells, in the brain and blood. It also checks changes in movement, thinking skills, and gut health.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of Parkinson's disease.
  • Score 26 or higher on the Montreal Cognitive Assessment (MoCA), a test of memory and thinking.
  • Be 50 to 80 years old.
  • Be able to read and write in English.

Who can't join

  • Have a pacemaker, a clip used to treat a bulging blood vessel, an artificial heart valve, an ear implant, or metal fragments in the eyes, skin, or body.
  • Have claustrophobia, a fear of enclosed spaces.
  • Have Parkinson's disease dementia or dementia with Lewy bodies, conditions that affect memory and thinking.
  • Have ever had cancer.
  • Currently have psychosis (trouble knowing what is real) or delirium (sudden confusion).
  • Have long-term kidney or liver disease within 30 days before joining, with kidney blood test creatinine above 1.5 mg/dL or liver blood tests AST or ALT at least 1.5 times the upper normal limit.
  • Use antioxidant treatments such as ashwagandha, gingko biloba, or N-acetylcysteine, or have drug abuse or dependence involving cocaine, heroin, marijuana, or fentanyl.
  • Have had a traumatic head injury.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

PA