Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients (MCI-GSH)
5. august 2026 opdateret af: Pravat Mandal
Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
9
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Pravat Pravat K MANDAL
- Telefonnummer: 4126999561
- E-mail: mandalpk@pitt.edu
Undersøgelse Kontakt Backup
- Navn: Nazia Pillar
- Telefonnummer: 878-670-3123
- E-mail: clinic55@pitt.edu
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15213
- Rekruttering
- UPMC Presbyterian Hospital
-
Kontakt:
- Pravat Mandal
- Telefonnummer: 4126999561
- E-mail: mandalpk@pitt.edu
-
Kontakt:
- Nazia Pillar
- E-mail: clinic55@pitt.edu
-
Underforsker:
- Riddhi Patira, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Memory complaints;
- MCI diagnosis
- MoCA score between 18-25
- Age 55 - 80 years old.
- Ability to read and write in English
Exclusion Criteria:
- 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)
- Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse/dependence;
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Gamma - Glutamylcystiene 400
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.
|
400mg capsules once a day
400mg capsules orally (two times) per day
|
|
Eksperimentel: Gamma - Glutamylcystiene 800
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months
|
400mg capsules once a day
400mg capsules orally (two times) per day
|
|
Eksperimentel: Gamma - Glutamylcystiene 1200
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months
|
400mg capsules orally (three times) per day
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.
Tidsramme: 1 month
|
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
|
1 month
|
|
Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
Tidsramme: 3 months
|
Safety and Tolerability
|
3 months
|
|
Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.
Tidsramme: 3 months
|
Safety and tolerability
|
3 months
|
|
Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.
Tidsramme: 3 months
|
Safety and tolerabitily
|
3 months
|
|
Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.
Tidsramme: 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.
|
3 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.
Tidsramme: 3.5 months
|
3.5 months
|
|
Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.
Tidsramme: 3.5 months
|
3.5 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pravat Mandal, PhD, University of Pittsburgh
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Mandal PK, Saharan S, Tripathi M, Murari G. Brain glutathione levels--a novel biomarker for mild cognitive impairment and Alzheimer's disease. Biol Psychiatry. 2015 Nov 15;78(10):702-10. doi: 10.1016/j.biopsych.2015.04.005. Epub 2015 Apr 14.
- Roy RG, Mandal PK, Maroon JC. Oxidative Stress Occurs Prior to Amyloid Abeta Plaque Formation and Tau Phosphorylation in Alzheimer's Disease: Role of Glutathione and Metal Ions. ACS Chem Neurosci. 2023 Sep 6;14(17):2944-2954. doi: 10.1021/acschemneuro.3c00486. Epub 2023 Aug 10.
- Mandal PK, Dwivedi D, Joon S, Goel A, Ahasan Z, Maroon JC, Singh P, Saxena R, Roy RG. Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application. ACS Chem Neurosci. 2023 Jun 21;14(12):2375-2384. doi: 10.1021/acschemneuro.3c00168. Epub 2023 May 31.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
4. august 2026
Primær færdiggørelse (Anslået)
1. januar 2027
Studieafslutning (Anslået)
1. februar 2027
Datoer for studieregistrering
Først indsendt
29. april 2026
Først indsendt, der opfyldte QC-kriterier
6. maj 2026
Først opslået (Faktiske)
13. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY26020048
- 0021 (Andet bevillings-/finansieringsnummer: Robert J. Coury Family - Mylan Foundation)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data underlying the primary and secondary outcome analyses will be provided after the study data is analyzed and published.
A comprehensive report will be sent to the IRB.
The respective agency will be reported accordingly.
Requests for the release of data must be submitted in writing to the PI, clearly stating the purpose of the request, the specific data needed, and the intended use.
The PI, in collaboration with the research team, will review each request to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements.
IPD-deling Understøttende informationstype
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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