Status:

RECRUITING

Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease

Lead Sponsor:

Baylor College of Medicine

Collaborating Sponsors:

The Methodist Hospital Research Institute

Conditions:

Alzheimer Disease

Eligibility:

All Genders

55-85 years

Phase:

EARLY_PHASE1

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...

Detailed Description

Glutathione (GSH) deficiency, oxidative stress, mitochondrial dysfunction, insulin resistance and inflammation are linked to Alzheimer's disease (AD). In prior studies, investigators have shown that G...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

February 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2026

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT04740580

Start Date

February 15 2022

End Date

December 31 2026

Last Update

June 10 2025

Active Locations (1)

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1

Baylor College of Medicine

Houston, Texas, United States, 77030