Actively Recruiting
Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Through Dose Response and Treatment Target Engagement
Led by Weill Medical College of Cornell University · Updated on 2026-02-25
95
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of N-acetylcysteine (NAC) as a potential treatment for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a disorder with no validated therapies. This phase two, double-blind, placebo-controlled trial aims to better understand how NAC influences brain glutathione (GSH) levels and markers of oxidative stress, which may help protect the brain against oxidative damage in ME/CFS patients. The study involves 60 participants divided into three groups, each receiving either a placebo (0 mg/day NAC), 900 mg/day NAC, or 3600 mg/day NAC for four weeks. Participants will self-administer NAC or placebo caplets daily during this period. Baseline and follow-up visits will include blood tests, survey questionnaires, MRI, and magnetic resonance spectroscopy imaging to assess changes in brain GSH and oxidative stress markers. Participants will undergo initial screening to confirm low GSH levels before starting treatment. After four weeks of supplementation, they will repeat the baseline assessments to measure treatment response. Researchers will monitor changes in brain GSH levels and plasma oxidative stress markers to evaluate NAC's potential effects. The study concludes in April 2026.
CONDITIONS
Brief Title
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females, ages 21 to 60 years (inclusive)
- Baseline glutathione (GSH) levels at or below a predefined cutoff
- Primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
- Willing and capable of providing informed consent
You will not qualify if you...
- Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders
- Any significant neurological illness or impairment
- Other unstable medical conditions such as asthma, hypertension, endocrine or metabolic disease
- History of alcohol abuse
- Positive urine toxicology at screening and on assessment days
- Positive pregnancy test at screening or on assessment days
- Contraindication for clinical MRI scan (e.g., pacemaker, metallic prosthesis)
- Baseline glutathione (GSH) levels higher than a predefined cutoff
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for blood tests and eligibility assessments including baseline GSH level
Duration - 4 weeks
Participants who pass screening self-administer N-acetylcysteine (NAC) or placebo caplets daily for four weeks.
Daily self-administration of study medication with no required visits during this period
Duration - 1 day
Participants undergo repeat assessments including blood collection, survey questionnaires, and MRI/MRS imaging to measure treatment response.
1 visit (in-person) to repeat baseline assessments after 4 weeks of treatment
Trial Site Locations
Total: 1 location
1
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
Research Team
X
Xiangling Mao, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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