Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age55-80
SponsorPravat Mandal

About this trial

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.

Eligibility criteria

Qualifiers

Memory complaints;

MCI diagnosis

MoCA score between 18-25

Age 55 - 80 years old.

Disqualifiers

Subjects with acute head trauma or head injury involving loss of consciousness;

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)

Trial design

Treatments tested in this trial

  • Gamma- Glutamylcysteine
  • Gamma- Glutamylcysteine
  • Gamma- Glutamylcusteine

Treatment groups

9 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Pravat Mandal

Lead sponsor

University of Pittsburgh

Sponsor institution

Robert J. Coury Family - Mylan Foundation

Collaborator

Inid Research Lab

Collaborator