Last updated: March 25, 2024
Sponsor: Thomas Jefferson University
Overall Status: Active - Enrolling
Phase
N/A
Condition
Memory Loss
Multiple Sclerosis
Scar Tissue
Treatment
N-acetyl Cysteine
Clinical Study ID
NCT03032601
16D.672
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Clinical diagnosis of relapsing remitting MS or progressive MS who do not plan tostart a medication during the study, or on stable disease modifying medication (interferon, glatiramer, dimethyl fumarate, teriflunomide).
- Age 18 years old to no upper limit
- Physically independent, ambulatory
- Women of childbearing potential will confirm a negative pregnancy test and mustpractice effective contraception during the period of pilot study. In addition, malesubjects who have a partner of childbearing age should practice effectivecontraception.
- Participants must be able to complete study procedures in the greater Philadelphiaarea.
Exclusion
Exclusion Criteria:
- Patients are excluded who have received treatment with intravenous steroids within thepast 90 days for reasons other than MS
- Previous brain surgery that would interfere with determination of cerebral metabolismor structure on the FDG PET-MRI.
- Score on Mini-Mental Status examination of 20 or lower.
- Wheelchair-bound or bed-ridden, non-ambulatory.
- Intracranial abnormalities that may complicate interpretation of the brain scans (e.g., stroke, tumor, vascular abnormality affecting the target area).
- History of head trauma with loss of consciousness > 48 hours.
- History of asthma requiring daily medications for adequate management.
- Any medical disorder or physical condition that could reasonably be expected tointerfere with the assessment of MS symptoms, or with any of the study assessmentsincluding the PET-MRI imaging.
- Patients with evidence of a significant psychiatric disorder by history/examinationthat would prevent completion of the study will not be allowed to participate.
- Patients with current alcohol or drug abuse
- Pregnant or lactating women.
- Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
- Pending surgery during the course of the study.
- Patients taking medications that might interact with NAC involved in this study willbe evaluated on a case by case basis by the PI or study physician. These medicationsinclude: Medications for high blood pressure; Medications that slow blood clotting;Medications for diabetes; Nitroglycerin.
- Patients with history of pulmonary hypertension.
- Any neurological, psychiatric, or medical condition that might affect the distributionof the radiopharmaceutical in the body or brain (as determined by Investigator)
- Currently using medications that might alter the distribution of radiopharmaceuticalsin - -the body or brain (as determined by Investigator)
- Patient exceeds the weight limit of the table
- Claustrophobia that would prevent completion of imaging studies
- Glucose level that would interfere with the FDG PET scan
- Any additional contraindications for MRI; Has metallic objects (e.g., pacemakers) inthe body
Study Design
Total Participants: 55
Treatment Group(s): 1
Primary Treatment: N-acetyl Cysteine
Phase:
Study Start date:
January 05, 2017
Estimated Completion Date:
January 05, 2025
Study Description
Connect with a study center
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
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