RecruitingEarly Phase 1NCT04740580

Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease


Sponsor

Baylor College of Medicine

Enrollment

52 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 YearsMax Age: 85 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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;
  • untreated depression or other severe psychiatric disorders;
  • pregnancy or nursing (unlikely in this population)

Interventions

DIETARY_SUPPLEMENTGlycine

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

DIETARY_SUPPLEMENTN-acetylcysteine

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

DIETARY_SUPPLEMENTAlanine

The placebo arm will supplement Alanine


Locations(1)

Baylor College of Medicine

Houston, Texas, United States

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NCT04740580


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