Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT04740580
Phase
EARLY_PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Glycine — DIETARY_SUPPLEMENT
    The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
  • N-acetylcysteine — DIETARY_SUPPLEMENT
    The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
  • Alanine — DIETARY_SUPPLEMENT
    The placebo arm will supplement Alanine

Study Details

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.

Key Dates

Start date
Feb 15, 2022
Status verified
Jun 2025
Primary completion
Apr 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

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

Primary Outcome Measure

Cognition [ Time Frame: Day 0 of supplementation, and 12-weeks and 24-weeks after starting supplementation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030
Rajagopal V Sekhar, MD
713-798-3908

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