Gamma Glutamylcysteine for Mild Cognitive Impairment
(MCI-GSH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an oral supplement called Gamma Glutamylcysteine (GGC) to determine its safety for individuals with mild cognitive impairment (MCI), often associated with memory problems. Participants will take varying doses of GGC for three months to collect preliminary safety data, aiding in the design of larger future studies. Individuals with memory complaints and an MCI diagnosis who can read and write in English may be suitable candidates. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking antioxidant supplements like ashwagandha, gingko biloba, N-acetylcysteine, or glutathione. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that Gamma Glutamylcysteine is likely to be safe for humans?
Research shows that Gamma Glutamylcysteine (GGC) is under study to assess its safety and tolerability. Earlier studies suggest that GGC might aid memory and cognitive issues. These studies tested daily doses of 400mg, 800mg, and 1200mg.
As an early-phase trial, the primary goal is to evaluate GGC's safety in humans. Early-phase trials mark the initial step in human testing, with close monitoring for side effects.
If GGC proves safe and well-tolerated, it could pave the way for further studies. So far, these early studies have not reported any major serious side effects. However, research continues, and this trial will provide more detailed safety information.12345Why do researchers think this study treatment might be promising for mild cognitive impairment?
Gamma Glutamylcysteine (GGC) is unique because it offers a potential new way to tackle mild cognitive impairment by boosting the body's antioxidant defenses. Unlike standard treatments that often focus on managing symptoms, GGC directly targets oxidative stress, which is believed to play a role in cognitive decline. Researchers are excited about GGC because it could provide a more direct approach to protecting brain health, potentially leading to improved cognitive function with its novel mechanism of action.
What evidence suggests that Gamma Glutamylcysteine might be an effective treatment for mild cognitive impairment?
Research has shown that Gamma Glutamylcysteine (GGC) might aid mild memory and thinking problems by boosting antioxidants like glutathione in the brain. Studies have found a link between lower levels of these antioxidants and memory and thinking decline. GGC supplements may help prevent or treat these issues by reducing oxidative stress, which can harm brain cells. Early findings suggest that GGC could enhance brain health and protect against further damage. Although more research is needed, these initial results offer promise for those facing mild cognitive challenges.12346
Who Is on the Research Team?
Pravat Mandal, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for people aged 55 to 80 who have mild memory problems (MCI), a MoCA score between 18-25, and can read and write in English.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Gamma Glutamylcysteine (GGC) supplementation at doses of 400mg, 800mg, or 1200mg daily for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gamma Glutamylcysteine
Trial Overview
The study tests the safety of taking different daily doses (400mg, 800mg, or 1200mg) of an oral supplement called Gamma Glutamylcysteine (GGC) over three months in people with mild cognitive impairment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pravat Mandal
Lead Sponsor
Robert J. Coury Family - Mylan Foundation
Collaborator
Inid Research Lab
Collaborator
Citations
Safety And Tolerability Of Gamma Glutamylcysteine (GGC) ...
The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day ...
Gamma Glutamylcysteine for Mild Cognitive Impairment · ...
The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day ...
3.
ctv.veeva.com
ctv.veeva.com/study/safety-and-tolerability-of-gamma-glutamylcysteine-ggc-oral-supplementation-in-mci-patientsSafety And Tolerability Of Gamma Glutamylcysteine (GGC ...
The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day ...
Supplementation with γ-glutamylcysteine (γ-GC) lessens ...
Our data collectively suggested that supplementation with γ-GC may represent a novel strategy for the treatment and/or prevention of cognitive impairment and ...
Elevation of Glutathione as a Therapeutic Strategy in ... - PMC
This study confirms that a decrease of antioxidants, particularly reduced glutathione, over time is a major contributor to the progression of MCI to AD.
Safety And Tolerability Of Gamma Glutamylcysteine (GGC) ...
The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day or 800mg/day or …
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.