Glutathione in Mild Cognitive Impairment
- Conditions
- Mild Cognitive Impairment
- Registration Number
- NCT03493178
- Lead Sponsor
- Baylor College of Medicine
- Brief Summary
Elderly humans have an increased risk of dementia which begins as mild defects in memory called mild cognitive impairment. Glutathione (GSH), a key endogenous antioxidant has been linked to cognition. This exploratory study will investigate mechanisms linked to GSH for cognitive impairment (and improvement) by studying humans with mild cognitive impairment who will be evaluated 12-weeks after receiving either N-acetylcysteine and glycine (GSH precursors), or receiving alanine, and a further 12-weeks after stopping these supplements.
- Detailed Description
Subjects with MCI will be recruited by written informed consent using forms approved by the Baylor IRB. Subjects will stop nonvitamin supplements for 4wks before screening labs (blood count, HbA1c, glucose, lipid profile, liver profile, blood urea nitrogen, Creatinine, thyroid stimulating hormone, free T4), and for the entire 24wks duration of the study. 60 fasted subjects will have the following measures before and after 12wks of supplementation with cysteine (as N-acetylcysteine) plus glycine vs alanine: (1) Cognitive function using ADCS-PACC (Alzheimer's Disease Co-operative Study-Preclinical Alzheimer's Cognitive Composite which includes Free and Cued Selective Reminding Test, Immediate and Delayed paragraph recall score, Digit-Symbol Substitution Test, Mini mental state examination; (2) Red-cell concentrations of GSH, cysteine, glycine, glutamic acid; plasma malondialdehyde, F2/F3-isoprostanes, sICAM, sVCAM, E-selectin; endothelial function; (3) Mitochondrial glucose oxidation by calorimetry. Measures will be repeated for washout effects 12-wks after stopping supplements.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cognition Change between 0-weeks and 12-weeks Measured using ADCS-PACC
- Secondary Outcome Measures
Name Time Method Concentrations of Glutathione Change between 0-weeks and 12-weeks Measured in red cells
Concentrations of TBARS, F2,F3 isoprostanes Change between 0-weeks and 12-weeks Measured in plasma
Endothelial function markers sICAM, sVCAM, E-selectin Change between 0-weeks and 12-weeks Measured in plasma
Endothelial function Change between 0-weeks and 12-weeks Measured using the EndoPAT system
Mitochondrial fuel oxidation in fasted and fed states Change between 0-weeks and 12-weeks Measured using calorimetry
Insulin resistance Change between 0-weeks and 12-weeks Measured as HOMA-IR
Trial Locations
- Locations (1)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Baylor College of Medicine🇺🇸Houston, Texas, United States