Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
Recruiting · NCT04740580 · Interventional (participants receive a specific treatment) · Lead sponsor: Baylor College of Medicine
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
55 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- Baylor College of Medicine - Houston, Texas, United States