Recruiting
Phase 1

GGC

Sponsor:

Pravat Mandal

Code:

NCT07064005

Conditions

Parkinsons Disease (PD)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Gamma- glutamylcysteine

Study Details

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. 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.

Conditions

Parkinsons Disease (PD)

Study ID

NCT07064005

Start date

Mar 23, 2026

Status verified date

May, 2026

Completion date

Nov 27, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Gamma - Glutamylcysteine

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

Interventions

Gamma- glutamylcysteine

400 mg (two times) per day

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Pravat K MANDAL, PHD

4126999561mandalpk@pitt.edu

Nazia Pillar, M.S

878-670-3123naa430@pitt.edu

Locations

UPMC Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Pravat K Mandal, PhD

4126999561mandalpk@pitt.edu

More Information

Sponsor

Pravat Mandal

Last update posted

May 4, 2026

Last verified

May, 2026

Keywords

  • Blood
  • Brain
  • MR Spectroscopy
  • GGC
  • Glutathione
  • Parkinsons disease
  • Oxidative stress
  • Brain Iron

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pravat Mandal on 2026-05-04.