NCT07064005

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. 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. 2.To study the changes in motor function, cognitive skills in PD patients due to GGC oral supplementation
  3. 3.To study impact of GGC on gut health on the PD patients.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
18mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Nov 2027

First Submitted

Initial submission to the registry

June 27, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2027

Last Updated

May 4, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

June 27, 2025

Last Update Submit

May 1, 2026

Conditions

Parkinsons Disease (PD)

Keywords

BloodBrainMR SpectroscopyGGCGlutathioneParkinsons diseaseOxidative stressBrain Iron

Outcome Measures

Primary Outcomes (4)

  • Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.

    MEGA-PRESS is a non-invasive imaging technique, to detect various neurochemical (e.g., Glutathione) using 1H MR spectroscopy.

    12 months

  • Changes in brain iron levels (ppb) in people with Parkinson's Disease using Magnetic Resonance Imaging between pre and post GGC supplementation.

    12 months

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

    12 months

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

    12 months

Secondary Outcomes (5)

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

    12 months

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

    12 months

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

    12 months

  • 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.

    12 months

  • 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.

    12 months

Study Arms (1)

Gamma - Glutamylcysteine

EXPERIMENTAL

Patients will receive GGC tablet 400mg orally twice a day (morning and in the afternoon).

Drug: Gamma- glutamylcysteine

Interventions

Gamma- glutamylcysteineDRUG

400 mg (two times) per day

Also known as: GGC
Gamma - Glutamylcysteine

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Related Publications (3)

  • Dias V, Junn E, Mouradian MM. The role of oxidative stress in Parkinson's disease. J Parkinsons Dis. 2013;3(4):461-91. doi: 10.3233/JPD-130230.

    PMID: 24252804BACKGROUND

  • Shukla D, Goel A, Mandal PK, Joon S, Punjabi K, Arora Y, Kumar R, Mehta VS, Singh P, Maroon JC, Bansal R, Sandal K, Roy RG, Samkaria A, Sharma S, Sandhilya S, Gaur S, Parvathi S, Joshi M. Glutathione Depletion and Concomitant Elevation of Susceptibility in Patients with Parkinson's Disease: State-of-the-Art MR Spectroscopy and Neuropsychological Study. ACS Chem Neurosci. 2023 Dec 20;14(24):4383-4394. doi: 10.1021/acschemneuro.3c00717. Epub 2023 Dec 5.

    PMID: 38050970BACKGROUND

  • Mandal PK, Dwivedi D, Joon S, Goel A, Ahasan Z, Maroon JC, Singh P, Saxena R, Roy RG. Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application. ACS Chem Neurosci. 2023 Jun 21;14(12):2375-2384. doi: 10.1021/acschemneuro.3c00168. Epub 2023 May 31.

    PMID: 37257017BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

gamma-glutamylcysteine

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Pravat K Mandal, PHD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pravat K MANDAL, PHD

CONTACT

4126999561mandalpk@pitt.edu

Nazia Pillar, M.S

CONTACT

878-670-3123naa430@pitt.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 14, 2025

Study Start

March 23, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

November 27, 2027

Last Updated

May 4, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) collected during the trial, specifically data such as specimen type, relevant clinical characteristics based on primary and secondary outcome measures as reported in the summary results.

Shared Documents
CSR
Time Frame
The IPD report will be accessible starting 6 months after publication of the main results.
Access Criteria
Collaborating researchers with IRB approval or individuals listed on data use agreements may obtain data or specimens. The PI, Dr. Pravat K Mandal, University of Pittsburgh, mandalpk@pitt.edu, in collaboration with the research team, will review each request through email to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements. All requests will be reviewed and responded to within 30 days.

Locations

US(1)