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

ConditionMild Cognitive Impairment (MCI)
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • 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

Treatment groups

9 Participants
are divided into 3 treatment groups
Group A: Gamma - Glutamylcystiene 400Experimental treatment 1 intervention
Group B: Gamma - Glutamylcystiene 800Experimental treatment 1 intervention
Group C: Gamma - Glutamylcystiene 1200Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.

Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.

Time frame
1 month
2

Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.

Safety and Tolerability

Time frame
3 months
3

Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.

Safety and tolerability

Time frame
3 months
4

Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.

Safety and tolerabitily

Time frame
3 months

Secondary outcomes

1

Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.

Time frame
3.5 months
2

Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.

Time frame
3.5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pravat Mandal

Lead sponsor

University of Pittsburgh

Sponsor institution

Robert J. Coury Family - Mylan Foundation

Collaborator

Inid Research Lab

Collaborator

Source ClinicalTrials.gov
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