Gamma-glutamylcysteine for Parkinson's Disease

(PDGSH Trial)

Overseen By Nazia Pillar, M.S

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pravat Mandal

Must not be taking: Antioxidants, Illicit drugs

Disqualifiers: Cancer, Psychosis, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called gamma-glutamylcysteine (GGC) for individuals with early Parkinson's disease. Researchers aim to determine if GGC can boost antioxidant levels in the brain and blood, potentially improving movement, thinking skills, and gut health. Those with Parkinson's who can read and write in English and do not have metal implants or a history of cancer might qualify for this study. Participants will take GGC tablets twice daily. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antioxidant therapy like ashwagandha, gingko biloba, or N-acetylcysteine.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that gamma-glutamylcysteine (GGC) is generally safe. Studies have found that GGC is well-tolerated in animal tests, even at high doses, with no serious safety issues reported. Additionally, a safety review of GGC sodium salt confirmed its safety according to international guidelines.

These results are based on early studies and animal data, highlighting the need for human testing. This trial is in its early phase and primarily focuses on assessing safety in people. This step is crucial to ensure the treatment's safety for humans. While more human research is needed, the current data is encouraging. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's disease?

Gamma-glutamylcysteine is unique because it targets oxidative stress, a key factor in Parkinson's disease progression, by boosting the body's natural antioxidant defenses. Unlike standard treatments like Levodopa, which mainly address symptoms by replenishing dopamine, Gamma-glutamylcysteine works fundamentally differently by enhancing cellular protection. Researchers are excited about this treatment because it has the potential to slow down the disease's progression, not just manage symptoms.

What evidence suggests that gamma-glutamylcysteine might be an effective treatment for Parkinson's disease?

Research has shown that gamma-glutamylcysteine (GGC), the treatment under study in this trial, can increase levels of glutathione, an important antioxidant that protects brain cells. Antioxidants are crucial because they help reduce oxidative stress, which plays a significant role in the development of Parkinson's disease. Studies have found that oxidative stress and mitochondrial issues (the cell's energy producers) are key factors in Parkinson’s progression. By boosting glutathione levels, GGC might help protect brain cells and improve symptoms like movement and cognitive problems. Although more research is needed to confirm these benefits for people with Parkinson's, GGC's mechanism shows promise for reducing brain cell damage. ^{2 6 7 8 9}

Who Is on the Research Team?

Pravat K Mandal, PHD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for early-stage Parkinson's Disease patients. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of Parkinson's.

Inclusion Criteria

Ability to read and write in English

Montreal Cognitive Assessment (MoCA) greater than or equal to 26

I have been diagnosed with Parkinson's Disease.

Exclusion Criteria

Active psychosis or delirium

I do not use antioxidant therapies or illicit drugs.

Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive GGC oral supplementation, 400mg twice a day, to evaluate changes in brain and blood glutathione levels, motor function, cognitive skills, and gut health

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gamma-glutamylcysteine

Trial Overview The study tests if taking Gamma-glutamylcysteine (GGC) orally can increase glutathione levels in the brain and blood, improve motor functions and cognitive skills, and benefit gut health in Parkinson's patients.

How Is the Trial Designed?

Group I: Gamma - Glutamylcysteine Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Pravat Mandal

Lead Sponsor

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Waste Connections Inc

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07064005

Enrichment of Glutathione Using Gamma-glutamylcysteine ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4857623/

Anti-Oxidants in Parkinson's Disease Therapy: A Critical Point ... Strong evidence now exists indicating that oxidative stress and mitochondrial dysfunction play a central role in the progression of the disorder.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0149763420306047

The glutathione system in Parkinson's disease and its ... The glutathione (L‐γ‐glutamyl‐L‐cysteinyl‐glycine; GSH) system is the most important antioxidant defense protecting normal cellular function and cell viability.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5438472/

Phase IIb Study of Intranasal Glutathione in Parkinson's Disease Results: All cohorts improved over the intervention period, including placebo. The high-dose group demonstrated improvement in total Unified PD ...

5. researchgate.net researchgate.net/publication/391945641_Determination_of_Gamma-Glutamylcysteine_Ethyl_Ester_Efficacy_via_Enzymatic_Analysis_in_Moderate_Traumatic_Brain_Injury

Determination of Gamma-Glutamylcysteine Ethyl Ester ... Methods: This study investigates the efficacy of gamma-glutamylcysteine ethyl ester (GCEE), a glutathione analog, as a post-therapeutic treatment option in ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0273230012000906

Safety assessment of gamma-glutamylcysteine sodium salt GGC sodium salt was demonstrated to be safe according to Organisation for Economic Cooperation and Development (OECD) toxicology protocols for acute and ...

7. nature.com nature.com/articles/s41598-020-58306-x

Serum gamma-glutamyltransferase activity and Parkinson's ... The top quartile of serum GGT (geometric means, 90.44 IU/L in men and 41.86 IU/L in women) was associated with a lower risk in men (adjusted HR = 0.72 (95% CI: ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5284489/

Oral administration of γ-glutamylcysteine increases ... Animal safety trials have demonstrated γ-GC to be safe at limit acute and repeated doses [36]. Change in GSH content of lymphocytes was chosen ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16644116/

relevance to the role of glutathione in Parkinson's disease This data suggests that prevention of glutathione depletion is a likely therapeutic target for the disease.