NCT04740580 Glutathione, Brain Metabolism and Inflammation in Alzheimer's Disease
| NCT ID | NCT04740580 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Baylor College of Medicine |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 52 participants in total. It began in 2022-02-15 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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)
Contact & Investigator
Rajagopal V Sekhar, M.D.
PRINCIPAL INVESTIGATOR
Baylor College of Medicine
Frequently Asked Questions
Who can join the NCT04740580 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 85 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04740580 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04740580 currently recruiting?
Yes, NCT04740580 is actively recruiting participants. Contact the research team at rsekhar@bcm.edu for enrollment information.
Where is the NCT04740580 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT04740580 clinical trial?
NCT04740580 is sponsored by Baylor College of Medicine. The principal investigator is Rajagopal V Sekhar, M.D. at Baylor College of Medicine. The trial plans to enroll 52 participants.
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