UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Location contact
Nazia Pillar
CONTACT
Pravat Mandal
CONTACT
Riddhi Patira, MD
SUB_INVESTIGATOR
NCT Number: NCT07583251
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.
Interested in participating?
Request Info55 year–80 year
All sexes
Interventional
Phase 1
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Nazia Pillar
CONTACT
Pravat Mandal
CONTACT
Riddhi Patira, MD
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
400mg capsules once a day
400mg capsules orally (three times) per day
Time frame: 1 month
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
Time frame: 3 months
Safety and Tolerability
Time frame: 3 months
Safety and tolerability
Time frame: 3 months
Safety and tolerabitily
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.
Time frame: 3.5 months
Time frame: 3.5 months
Contact information is provided by the study sponsor or research team.
Nazia Pillar
CONTACT
Pravat Pravat K MANDAL
CONTACT
Pravat Mandal
Other
Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
Acronym: MCI-GSH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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