Effects of GlyNAC supplementation on Alzheimer's disease
Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
This study is testing if taking GlyNAC can help improve thinking and memory in people with Alzheimer's disease by reducing inflammation and boosting brain health.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04740580 on ClinicalTrials.gov |
What this trial studies
This trial investigates the impact of GlyNAC supplementation, which includes glycine and N-acetylcysteine, on cognitive decline in patients with Alzheimer's disease. Participants will receive either GlyNAC or a placebo (alanine) for 24 weeks, with assessments of cognition, oxidative stress, brain glucose uptake, and inflammation conducted before and after the intervention. The study aims to address mitochondrial dysfunction and inflammation linked to Alzheimer's by correcting glutathione deficiency. Imaging studies will be performed to evaluate brain metabolism and inflammation.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-85 with progressive memory loss and positive beta-amyloid PET scans.
Not a fit: Patients with recent hospitalization, untreated thyroid disease, or significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and metabolic health in patients with Alzheimer's disease.
How similar studies have performed: Previous studies have indicated that correcting glutathione deficiency can improve mitochondrial function, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Houston, Texas
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Rajagopal V Sekhar, M.D. — Baylor College of Medicine
- Study coordinator: Rajagopal V Sekhar, M.D.
- Email: rsekhar@bcm.edu
- Phone: 7137983908
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.