Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gamma- Glutamylcysteine, Gamma- Glutamylcysteine, Gamma- Glutamylcusteine.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment (MCI). Basic parameters: 55 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
Overview
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.
Interventions
- Drug Gamma- Glutamylcysteine
400mg capsules once a day - Drug Gamma- Glutamylcysteine
400mg capsules orally (two times) per day - Drug Gamma- Glutamylcusteine
400mg capsules orally (three times) per day
Primary outcome measures
- No. of participants with abnormal kidney and liver function tests after 30 days of supplementation. [Time frame: 1 month]
- Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE. [Time frame: 3 months]
- Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE. [Time frame: 3 months]
- Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE. [Time frame: 3 months]
- Number of participants with abnormal laboratory test results after 3 months of GGC supplementation. [Time frame: 3 months]
Secondary outcome measures (2)
- 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]
Eligibility criteria
Inclusion criteria
- Memory complaints;
- MCI diagnosis
- MoCA score between 18-25
- Age 55 - 80 years old.
- Ability to read and write in English
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UPMC Presbyterian Hospital — Pittsburgh
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. PMID 37561556
- Mandal 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. PMID 26003861
- 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 37257017
Identifiers
NCT: NCT07583251 · STUDY26020048 · 0021