Chronic Fatigue Syndrome Clinical Trial
— NAC ME/CFSOfficial title:
Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement
Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto the mechanisms of action of NAC in brain GSH restoration, which could open a new avenue for the development of potentially effective treatments for a disorder, ME/CFS, that currently has none.
Status | Recruiting |
Enrollment | 95 |
Est. completion date | April 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility | Inclusion Criteria: - Males or females, ages 21 to 60 years (inclusive). - Baseline GSH levels at or less than a predefined cutoff value. - Primary diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). - Willing and capable of providing informed consent. Exclusion Criteria: - Significant and/or comorbid axis I (especially mood and anxiety) and axis II disorders. - Any significant neurological illness or impairment. - Other unstable medical conditions (asthma, hypertension, endocrine or metabolic disease, etc). - History alcohol abuse. - Positive urine toxicology at screening and on days of assessments. - Positive pregnancy test at screening or on days of assessments. - Contra-indication for clinical MRI scan (e.g., pacemaker, metallic prosthesis). - Baseline GSH levels higher than a predefined cutoff value. |
Country | Name | City | State |
---|---|---|---|
United States | Weill Cornell Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Weill Medical College of Cornell University | National Institute of Neurological Disorders and Stroke (NINDS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in GSH levels of treatment response: measure 1 | Levels of occipital cortex GSH, as measured in vivo with 1H MRS | pre/post 4 weeks of NAC supplementation | |
Primary | Change in GSH levels of treatment response: measure 2 | Levels of striatal GSH, as measured in vivo with 1H MRS | pre/post 4 weeks of NAC supplementation | |
Secondary | Change of levels of ventricular CSF lactate of treatment response | Levels of ventricular CSF lactate, as measured in vivo with 1H MRS | pre/post 4 weeks of NAC supplementation | |
Secondary | Change of regional cerebral blood flow (rCBF) of treatment response | Regional cerebral blood flow (rCBF), as measured in vivo with perfusion MRI | pre/post 4 weeks of NAC supplementation | |
Secondary | Change in Oxidative stress levels of treatment response: measure 1 | Level of F2-isoprostanes, a marker of oxidative stress, in plasma samples obtained | pre/post 4 weeks of NAC supplementation | |
Secondary | Change in Oxidative stress levels of treatment response: measure 2 | Level of 8-hydroxy-2-deoxy guanosine (8-OH-2dG), a DNA damage marker, in plasma samples obtained | pre/post 4 weeks of NAC supplementation | |
Secondary | Change in Oxidative stress levels of treatment response: measure 3 | Level of reduced (GSH) glutathione, an antioxidant capacity and redox state marker, in plasma obtained | pre/post 4 weeks of NAC supplementation | |
Secondary | Change in Oxidative stress levels of treatment response: measure 4 | Level of oxidized (GSSG) glutathione, an antioxidant capacity and redox state marker, in plasma obtained | pre/post 4 weeks of NAC supplementation | |
Secondary | Change in Oxidative stress levels of treatment response: measure 5 | Level of GSH peroxidase, an antioxidant enzyme activity marker, in plasma obtained | pre/post 4 weeks of NAC supplementation | |
Secondary | Change in Oxidative stress levels of treatment response: measure 6 | Level of protein carbonyls, a protein damage marker, in plasma obtained | pre/post 4 weeks of NAC supplementation |
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