Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Description

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.

Conditions

Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

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Study Overview

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Study Details

Study overview

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.

Mechanistic Assessment of N-Acetylcysteine as an Antioxidant Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Through Dose Response and Treatment Target Engagement

Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Condition
Chronic Fatigue Syndrome
Intervention / Treatment

-

Contacts and Locations

New York

Weill Cornell Medicine, New York, New York, United States, 10021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

21 Years to 60 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Weill Medical College of Cornell University,

Dikoma C. Shungu, Ph.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

Study Record Dates

2025-04-30