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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Pravat Mandal
Study ID
NCT07583251
Phase
PHASE1
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment (MCI)

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Gamma- Glutamylcysteine — DRUG
    400mg capsules once a day
  • Gamma- Glutamylcysteine — DRUG
    400mg capsules orally (two times) per day
  • Gamma- Glutamylcusteine — DRUG
    400mg capsules orally (three times) per day

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Gamma - Glutamylcystiene 400
    Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.
  • Experimental: Gamma - Glutamylcystiene 800
    Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months
  • Experimental: Gamma - Glutamylcystiene 1200
    Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months

Primary Outcome Measure

No. of participants with abnormal kidney and liver function tests after 30 days of supplementation. [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Presbyterian HospitalPittsburghPennsylvania15213
Pravat Mandal
[email protected]
4126999561
Nazia Pillar
[email protected]
Riddhi Patira, MD (SUB_INVESTIGATOR)

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By research site
UPMC Presbyterian Hospital· Pittsburgh, PA

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