drugset / Trial / NCT07583251
Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
Phase 1
Recruiting
9 enrolled
Pravat Mandal
Inid Research Lab · collabRobert J. Coury Family - Mylan Foundation · collab
Non-randomizedSequentialOpen-labelPrevention
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. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.
Timeline
- Start
- 2026-06
- Primary completion
- 2027-01
- Completion
- 2027-02
Publications
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gamma Glutamylcysteine | Unknown | 400 mg | Oral |
| Subject | Gamma Glutamylcysteine | Unknown | 800 mg | Oral |
| Subject | Gamma Glutamylcysteine | Unknown | 1200 mg | Oral |