Glutathione in Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Glutathione in Mild Cognitive Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03493178
• Other study ID #: H42035: Glutathione in MCI
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 14, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Baylor College of Medicine
• Contact: Rajagopal V Sekhar, MD
• Phone: 7137983908
• Email: rsekhar[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria at study entry: (1) Diagnosis of Mild Cognitive Impairment Exclusion Criteria at study entry: (1) hospitalization within past 3 months; (2) known diabetes; (3) creatinine greater than or equal to 1.5 mg/dL; (4) hemoglobin concentration less than 11 g/dL; (5) known liver disease, or AST/ALT greater than or equal to 2x ULN; (6) history of stroke, brain tumor, or active heart failure; (7) history of psychiatric disorders; (8) untreated depression.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Dietary Supplement:
• Glycine
Dietary Supplement: glycine will be supplemented in the active arm for 12-weeks
• N-acetylcysteine (NAC)
Dietary Supplement: NAC will be supplemented in the active arm for 12-weeks
• Alanine
Dietary Supplement: Alanine will be supplemented in the placebo arm for 12-weeks

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition	Measured using ADCS-PACC	Change between 0-weeks and 12-weeks
Secondary	Concentrations of Glutathione, cysteine, glycine, glutamic acid	Measured in red cells	Change between 0-weeks and 12-weeks
Secondary	Concentrations of malondialdehyde, F2,F3 isoprostanes	Measured in plasma	Change between 0-weeks and 12-weeks
Secondary	Endothelial function markers sICAM, sVCAM, E-selectin	Measured in plasma	Change between 0-weeks and 12-weeks
Secondary	Endothelial function	Measured using the EndoPAT system	Change between 0-weeks and 12-weeks
Secondary	Mitochondrial fuel oxidation in fasted and fed states	Measured using calorimetry	Change between 0-weeks and 12-weeks