RECRUITINGEarly Phase 1INTERVENTIONAL
Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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)
Treatments Being Tested
DIETARY_SUPPLEMENT
Glycine
The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
DIETARY_SUPPLEMENT
N-acetylcysteine
The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
DIETARY_SUPPLEMENT
Alanine
The placebo arm will supplement Alanine
Locations (1)
Baylor College of Medicine
Houston, Texas, United States