Mild Cognitive Impairment (MCI)Phase 1MCI-GSHNCT07583251
Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
A Phase 1 study testing Gamma- Glutamylcysteine and Gamma- Glutamylcusteine in people with Mild Cognitive Impairment (MCI), run by Pravat Mandal at 1 site in United States.
Trial summary
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 1200mg/day) when administered orally to patients with MCI over 3 months. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Gamma- Glutamylcysteine and Gamma- Glutamylcusteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Memory complaints;
- MCI diagnosis
- MoCA score between 18-25
- Age 55 - 80 years old.
- Ability to read and write in English
Who cannot join
- Subjects with a history of cancer;
- Subjects with a history of schizophrenia, manic-depressive disorder
- Subjects on antioxidant therapy (ashwagandha, gingko biloba, N-acetylcysteine or glutathione)
- Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse/dependence;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Pravat Mandal, 4126999561, mandalpk@pitt.edu
Nazia Pillar, clinic55@pitt.edu
About this study
Official title: Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
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 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.
Read the detailed description
Oxidative Stress (OS) plays a key role in aging and neurodegenerative diseases, including Alzheimer's Disease. The brain's primary antioxidant, GSH, is essential for combating Reactive Oxygen Species (ROS).This study is designed as an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of GGC supplementation in patients with MCI. This will enable the investigators to identify maximum tolerated or recommended dose for further clinical evaluation.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Gamma- Glutamylcysteine, Gamma- Glutamylcusteine
- Keywords
- GSH, GGC, MCI, cognitive
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma- GlutamylcysteineDrug
400mg capsules once a day
Gamma- GlutamylcysteineDrug
400mg capsules orally (two times) per day
Gamma- GlutamylcusteineDrug
400mg capsules orally (three times) per day
| Study group | Role | What they receive |
|---|---|---|
| Gamma - Glutamylcystiene 400 | Experimental | Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months. Receives: Drug: Gamma- Glutamylcysteine |
| Gamma - Glutamylcystiene 800 | Experimental | Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months Receives: Drug: Gamma- Glutamylcysteine |
| Gamma - Glutamylcystiene 1200 | Experimental | Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months Receives: Drug: Gamma- Glutamylcusteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
Measured: 1 month
Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
Safety and Tolerability
Measured: 3 months
Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.
Safety and tolerability
Measured: 3 months
Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.
Safety and tolerabitily
Measured: 3 months
Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.
Safety and tolerability: The number of participants experiencing clinically significant abnormal laboratory test results (hematology, kidney, and liver function tests) during 3 months of GGC supplementation, compared with baseline.
Measured: 3 months
Secondary outcomes (2)
Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.
Measured: 3.5 months
Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.
Measured: 3.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start4 Aug 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is designed as an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of GGC supplementation in patients with MCI. The participants will be given the GGC supplement: Group A: 400mg once a day/ Group B: 400 mg two times per day/ Group C: 400mg three times a day for three months. Group B starts after Group A's 30-day safety review. Group C starts after Group B's 30-day safety review is cleared. If 1 participant within the cohort(n=3) experiences dose-limiting toxicity (DLT) or clinically significant intolerance, the event will be reviewed by the clinician for severity, relatedness, and significance. Dose escalation may proceed if the event is not indicative of an overall safety concern (Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN).If 2 or all of the participants experience DLTs or clinically significant adverse events related to the study supplement, dose escalation will be halted.
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pravat Mandal
- Sponsor type
- University, hospital or other
- Collaborators
- Robert J. Coury Family - Mylan Foundation, Inid Research Lab
- Responsible party
- Sponsor-investigator, Pravat Mandal, University of Pittsburgh
- Investigators
- Pravat Mandal, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583251
- Sponsor's protocol ID
- STUDY26020048
- Other IDs
- 0021
- Acronym
- MCI-GSH
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcome analyses will be provided after the study data is analyzed and published. A comprehensive report will be sent to the IRB. The respective agency will be reported accordingly. Requests for the release of data must be submitted in writing to the PI, clearly stating the purpose of the request, the specific data needed, and the intended use. The PI, in collaboration with the research team, will review each request to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements.
Publications
Roy RG, Mandal PK, Maroon JC. Oxidative Stress Occurs Prior to Amyloid Abeta Plaque Formation and Tau Phosphorylation in Alzheimer's Disease: Role of Glutathione and Metal Ions. ACS Chem Neurosci. 2023 Sep 6;14(17):2944-2954. doi: 10.1021/acschemneuro.3c00486. Epub 2023 Aug 10.
PubMed 37561556Mandal PK, Saharan S, Tripathi M, Murari G. Brain glutathione levels--a novel biomarker for mild cognitive impairment and Alzheimer's disease. Biol Psychiatry. 2015 Nov 15;78(10):702-10. doi: 10.1016/j.biopsych.2015.04.005. Epub 2015 Apr 14.
PubMed 26003861Mandal 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.
PubMed 37257017
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
- ClinicalTrials.gov ID
- NCT07583251
- Acronym / sponsor ID
- MCI-GSH / STUDY26020048
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- GSH, GGC, MCI, cognitive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Pravat MandalUniversity, hospital or other
- Collaborators
- Robert J. Coury Family - Mylan Foundation, Inid Research Lab
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.
Detailed description
Oxidative Stress (OS) plays a key role in aging and neurodegenerative diseases, including Alzheimer's Disease. The brain's primary antioxidant, GSH, is essential for combating Reactive Oxygen Species (ROS).This study is designed as an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of GGC supplementation in patients with MCI. This will enable the investigators to identify maximum tolerated or recommended dose for further clinical evaluation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is designed as an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of GGC supplementation in patients with MCI. The participants will be given the GGC supplement: Group A: 400mg once a day/ Group B: 400 mg two times per day/ Group C: 400mg three times a day for three months. Group B starts after Group A's 30-day safety review. Group C starts after Group B's 30-day safety review is cleared. If 1 participant within the cohort(n=3) experiences dose-limiting toxicity (DLT) or clinically significant intolerance, the event will be reviewed by the clinician for severity, relatedness, and significance. Dose escalation may proceed if the event is not indicative of an overall safety concern (Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN).If 2 or all of the participants experience DLTs or clinically significant adverse events related to the study supplement, dose escalation will be halted.
| Arm | Type | Receives |
|---|---|---|
| Gamma - Glutamylcystiene 400 | Experimental | Drug: Gamma- GlutamylcysteineEach participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months. |
| Gamma - Glutamylcystiene 800 | Experimental | Drug: Gamma- GlutamylcysteineEach participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months |
| Gamma - Glutamylcystiene 1200 | Experimental | Drug: Gamma- GlutamylcusteineEach participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Memory complaints;
- MCI diagnosis
- MoCA score between 18-25
- Age 55 - 80 years old.
- Ability to read and write in English
Key exclusion criteria (4 listed)
- Subjects with a history of cancer;
- Subjects with a history of schizophrenia, manic-depressive disorder
- Subjects on antioxidant therapy (ashwagandha, gingko biloba, N-acetylcysteine or glutathione)
- Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse/dependence;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma- Glutamylcysteine400mg capsules once a day | Drug | Gamma - Glutamylcystiene 400 |
| Gamma- Glutamylcysteine400mg capsules orally (two times) per day | Drug | Gamma - Glutamylcystiene 800 |
| Gamma- Glutamylcusteine400mg capsules orally (three times) per day | Drug | Gamma - Glutamylcystiene 1200 |
Primary outcome
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.
Time frame: 1 month
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
Time frame: 3 months
Safety and Tolerability
Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.
Time frame: 3 months
Safety and tolerability
Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.
Time frame: 3 months
Safety and tolerabitily
Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.
Time frame: 3 months
Safety and tolerability: The number of participants experiencing clinically significant abnormal laboratory test results (hematology, kidney, and liver function tests) during 3 months of GGC supplementation, compared with baseline.
2 secondary outcomes
Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.
Time frame: 3.5 months
Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.
Time frame: 3.5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 37561556Roy RG, Mandal PK, Maroon JC. Oxidative Stress Occurs Prior to Amyloid Abeta Plaque Formation and Tau Phosphorylation in Alzheimer's Disease: Role of Glutathione and Metal Ions. ACS Chem Neurosci. 2023 Sep 6;14(17):2944-2954. doi: 10.1021/acschemneuro.3c00486. Epub 2023 Aug 10.
- Background: PubMed 26003861Mandal PK, Saharan S, Tripathi M, Murari G. Brain glutathione levels--a novel biomarker for mild cognitive impairment and Alzheimer's disease. Biol Psychiatry. 2015 Nov 15;78(10):702-10. doi: 10.1016/j.biopsych.2015.04.005. Epub 2015 Apr 14.
- Results publication: PubMed 37257017Mandal 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcome analyses will be provided after the study data is analyzed and published. A comprehensive report will be sent to the IRB. The respective agency will be reported accordingly. Requests for the release of data must be submitted in writing to the PI, clearly stating the purpose of the request, the specific data needed, and the intended use. The PI, in collaboration with the research team, will review each request to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pravat Mandal, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gamma- Glutamylcysteine and Gamma- Glutamylcusteine in people with Mild Cognitive Impairment (MCI), run by Pravat Mandal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pravat Pravat K MANDAL (4126999561, mandalpk@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation. (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07583251, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.