Glutathione in Mild Cognitive Impairment

NCT03493178 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: H42035: Glutathione in MCI
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Elderly humans have an increased risk of dementia which begins as mild defects in memory called mild cognitive impairment. Glutathione (GSH), a key endogenous antioxidant has been linked to cognition. This exploratory study will investigate mechanisms linked to GSH for cognitive impairment (and improvement) by studying humans with mild cognitive impairment who will be evaluated 12-weeks after receiving either N-acetylcysteine and glycine (GSH precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Cognition

  Measured using ADCS-PACC

  Change between 0-weeks and 12-weeks

Secondary Outcomes (6)

• Concentrations of Glutathione

  Change between 0-weeks and 12-weeks

• Concentrations of TBARS, F2,F3 isoprostanes

  Change between 0-weeks and 12-weeks

• Endothelial function markers sICAM, sVCAM, E-selectin

  Change between 0-weeks and 12-weeks

• Endothelial function

  Change between 0-weeks and 12-weeks

• Mitochondrial fuel oxidation in fasted and fed states

  Change between 0-weeks and 12-weeks

Study Arms (2)

MCI-active

ACTIVE COMPARATOR

30 Subjects with MCI will receive N-acetylcysteine and glycine for 12-weeks. ll subjects will be studied at baseline prior to supplementation, after completing 12-weeks of supplementation, and 12-weeks after stopping supplementation (i.e. at 24-weeks). Supplements are only provided for first 12-weeks.

Dietary Supplement: Glycine; Dietary Supplement: N-acetylcysteine (NAC)

MCI-placebo

PLACEBO COMPARATOR

30 subjects will received alanine for 12-weeks. All subjects will be studied at baseline prior to supplementation, after completing 12-weeks of supplementation, and 12-weeks after stopping supplementation (i.e. at 24-weeks). Supplements are only provided for first 12-weeks

Dietary Supplement: Alanine

Interventions

Glycine DIETARY_SUPPLEMENT

Dietary Supplement: glycine will be supplemented in the active arm for 12-weeks

MCI-active

N-acetylcysteine (NAC) DIETARY_SUPPLEMENT

Dietary Supplement: NAC will be supplemented in the active arm for 12-weeks

MCI-active

Alanine DIETARY_SUPPLEMENT

Dietary Supplement: Alanine will be supplemented in the placebo arm for 12-weeks

MCI-placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Glycine; Acetylcysteine; Alanine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: April 10, 2018
• Study Start: April 19, 2018
• Primary Completion: May 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)