Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
NCT07583251 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2026-05-13
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.
Conditions
- Mild Cognitive Impairment (MCI)
Interventions
- DRUG
-
Gamma- Glutamylcysteine
400mg capsules orally (two times) per day
- DRUG
-
Gamma- Glutamylcusteine
400mg capsules orally (three times) per day
- DRUG
-
Gamma- Glutamylcysteine
400mg capsules once a day
Sponsors & Collaborators
-
Robert J. Coury Family - Mylan Foundation
collaborator UNKNOWN -
Inid Research Lab
collaborator UNKNOWN -
Pravat Mandal
lead OTHER
Principal Investigators
-
Pravat Mandal, PhD · University of Pittsburgh
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 55 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-01-31
- Completion
- 2027-02-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
NCT00040443 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of MMFS in Early AD
NCT03531684 ·Status: COMPLETED ·Phase: PHASE2
-
Effects of Fermented Codonopsis Lanceolata on Improvement in Cognitive-Bio-Markers of Cognitive Functions
NCT03439098 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)
NCT06347315 ·Status: RECRUITING ·Phase: NA
-
Safety and Tolerability Study of Extended Release (ER) Galantamine in Alzheimer's Disease
NCT00082602 ·Status: COMPLETED ·Phase: PHASE3
-
B-vitamins Treatment for Improvement of Cognitive Function
NCT01095211 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of Genistein in Mild Cognitive Impairment
NCT07385937 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effect of BrainPhyt, a Microalgae Based Ingredient on Cognitive Function in Healthy Older Subjects
NCT04832412 ·Status: COMPLETED ·Phase: NA
-
Study to Assess the Efficacy of Cognitex
NCT00719953 ·Status: COMPLETED ·Phase: PHASE4
-
GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
NCT00414622 ·Status: COMPLETED ·Phase: PHASE2
-
Study Evaluating Safety, Tolerability, and PK of Multiple Ascending Doses of GC021109 in Subjects With Mild to Moderate Alzheimer's Disease
NCT02386306 ·Status: COMPLETED ·Phase: PHASE1
-
Tolerability & Pharmacokinetics of Ginkgolide B Injection: Single- and Multiple-Ascending Doses in Healthy Subjects
NCT07457008 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating GSI-953 in Healthy Young and Alzheimer's Patients
NCT00479219 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
NCT00236431 ·Status: COMPLETED ·Phase: PHASE3
-
The Memory and Cognitive Performance Study
NCT04025255 ·Status: COMPLETED ·Phase: NA
-
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
NCT00814801 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of T-817MA in Patients With Mild to Moderate Alzheimer's Disease
NCT00663936 ·Status: COMPLETED ·Phase: PHASE2
-
Crossover Trial for Nicotinamide Riboside in Subjective Cognitive Decline and Mild Cognitive Impairment
NCT04078178 ·Status: COMPLETED ·Phase: NA
-
Efficacy and Safety of 1612 Capsules in aMnestic Mild Cognitive Impairment
NCT02982642 ·Status: WITHDRAWN ·Phase: PHASE4
-
Study Evaluating Safety of GSI 136 in Young and Elderly Japanese Males
NCT00719394 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of the Effects on Sleep, Attention, and Gastrointestinal Tolerance of Galantamine and Donepezil in Patients With Alzheimer's Disease
NCT00035204 ·Status: COMPLETED ·Phase: PHASE4
-
Randomized Trial of a Nutritional Supplement in Alzheimer's Disease
NCT00678431 ·Status: COMPLETED ·Phase: PHASE3
-
Curcumin in Patients With Mild to Moderate Alzheimer's Disease
NCT00099710 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Efficacy and Safety of Galantamine in Patients With Mild Cognitive Impairment
NCT00236574 ·Status: COMPLETED ·Phase: PHASE3
-
Safety Study of Nicotinamide to Treat Alzheimer's Disease
NCT00580931 ·Status: COMPLETED ·Phase: PHASE1/PHASE2