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NCT Number: NCT07064005

Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.

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.

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Key information

Conditions

Parkinsons Disease (PD) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Pravat K Mandal, PhD

CONTACT

[email protected]

4126999561

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gamma- Glutamylcysteine

Drug

400 mg (two times) per day

Other names: GGC

Primary outcomes

  1. 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.

  2. 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

  3. Changes in baseline blood iron levels(ng/μl) in people with Parkinson's Disease

    Time frame: 12 months

  4. Changes in baseline blood glutathione levels (µmol/l) in people with Parkinson's Disease compared to post-supplementation with GGC

    Time frame: 12 months

Secondary outcomes

  1. Monitor the change in the motor function using Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) pre and post GGC supplementation.

    Time frame: 12 months

    Scoring Method: Each section of the UPDRS is scored on a scale from 0 to 4.The total UPDRS score is calculated by summing the scores from each section, ranging from 0 (no disability) to 176 (severe disability).

    Interpretation: Higher scores indicates greater severity of symptoms.

  2. Cognitive functions modulation- pre and post GGC supplementation using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

    Time frame: 12 months

    Interpretation: Higher scores indicate greater cognitive function.

  3. Changes from baseline in the psychological distress using Brief Symptom Inventory (BSI-18) (self-report) in people with Parkinson's Disease.

    Time frame: 12 months

    Scoring Method: Each item is scored on a 0-4 scale, with the total score indicating the severity of distress. Interpretation: Higher total scores indicate greater severity of psychological distress.

  4. Changes from baseline in the cognitive functions like memory, attention and decision-making using PROMIS Cognitive Function - Abilities-Short Form 8a (self-report) in people with Parkinson's Disease.

    Time frame: 12 months

    Scoring Method: Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty.

  5. Changes from baseline cognitive functions like attention, processing speed, and mental flexibility using Trail Making Test (TMT) A&B in people with Parkinson's Disease.

    Time frame: 12 months

    Scoring Method: The average scores are as follows: • Trail A - 29 seconds • Trail B - 75 seconds Interpretation: Higher scores indicate greater impairment

Study contacts

Contact information is provided by the study sponsor or research team.

Nazia Pillar, M.S

CONTACT

[email protected]

878-670-3123

Pravat K MANDAL, PHD

CONTACT

[email protected]

4126999561

Sponsors and collaborators

Lead sponsor

Pravat Mandal

Other

Collaborators

  • Waste Connections Inc

Registry information

Official study 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

Acronym: PDGSH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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