Status:
RECRUITING
Study of N-acetylcysteine in the Treatment of Patients With the m.3243A>G Mutation and Low Brain Glutathione Levels
Lead Sponsor:
Michio Hirano, MD
Collaborating Sponsors:
United States Department of Defense
Conditions:
Mitochondrial Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
N-Acetylcysteine (NAC), an anti-oxidant, will be studied to investigate the effects on brain glutathione levels, cognitive skills, motor skills, and quality of life. A group of 18 participants will t...
Detailed Description
Patients with the m.3243A\>G mitochondrial mutation often have low brain glutathione levels. These low levels can reduce the repair processes in the brain to fix toxic chemicals that result from a mit...
Eligibility Criteria
Inclusion
- Ages 18-80 years
- Low brain glutathione (GSH) levels as determined by magnetic resonance spectroscopic imaging (MRSI)
- Individuals who carry, or are suspected of carrying the m.3243A\>G mitochondrial mutation (genetic confirmation of mutation required prior to initiation of NAC)
Exclusion
- Individuals with normal brain glutathione levels
- Pregnant or lactating individuals
- Medically unstable as determined by the Principal Investigator
- Allergy to NAC or other sulfur-containing drug
- Inability to adhere to study protocol
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT05241262
Start Date
July 6 2023
End Date
April 1 2025
Last Update
September 19 2024
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032