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Not recruiting
Early Phase 1

Glutathione

Sponsor:

Baylor College of Medicine

Code:

NCT04740580

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Glycine

N-acetylcysteine

Alanine

Study Details

Brief summary:

Alzheimer's disease (AD) is associated with significant, progressive cognitive decline. Key defects in mitochondrial fuel metabolism insulin resistance, inflammation and decreased brain glucose uptake are linked to AD. This trial will investigate the effects of supplementing glycine and N-acetylcysteine vs. alanine as placebo on these defects in AD, and examine the effects on cognition.

Conditions

Alzheimer Disease

Study ID

NCT04740580

Start date

Feb 15, 2022

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Aug 30, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 55-85 years;
  • Gradual and progressive memory loss for more than 1 year, with a Montreal Cognitive Assessment score of 10-20;
  • Amyloid positivity on PET scan;
  • Availability of a study partner.

Exclusion Criteria:

  • hospitalization in past 3 months;
  • use of insulin medications;
  • untreated thyroid disease;
  • creatinine levels >1.5 mg/dL;
  • hemoglobin concentration <11.0 g/dL;
  • known liver disease, or AST/ALT level >2x ULN;
  • history of stroke, brain tumor, active heart failure or active cancer (removable basal cell cancers will not be an exclusion criteria);
  • untreated depression or other severe psychiatric disorders;
  • pregnancy or nursing (unlikely in this population)

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Glycine plus N-acetylcysteine

Glycine and cysteine are amino-acid (protein) precursors of glutathione. Cysteine is provided as N-acetylcysteine

placebo comparator: Alanine

Alanine is an amino-acid (protein), and not a precursor of glutathione synthesis

Interventions

Glycine

The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)

N-acetylcysteine

The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)

Alanine

The placebo arm will supplement Alanine

Primary outcome measure

  • Cognition [ Time Frame: Day 0 of supplementation, and 12-weeks and 24-weeks after starting supplementation ]
  • Brain glucose uptake [ Time Frame: Done before supplementation and 24-weeks after starting supplementation ]
  • Brain inflammation [ Time Frame: Done before supplementation and 24-weeks after starting supplementation ]

Central Contacts and Locations

More Information

Sponsor

Baylor College of Medicine

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2026-09-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.