Physiological Effects of N-Acetyl Cysteine in Patients With Multiple Sclerosis

The study consists of two arms. The first arm of this study will receive intravenous and oral
NAC, a strong antioxidant that increases brain glutathione. NAC, is the N-acetyl derivative
of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement
that is also available as an injectable pharmaceutical that protects the liver in cases of
acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC. It has
the potential to reduce markers of oxidative damage, protect against cell death, and to
increase glutathione in blood, which might be useful in preventing oxidative damage in MS
patients. The second arm will be a waitlist control receiving standard MS care. It should be
noted that both arms will receive standard of care treatment for MS while enrolled in the
study.

Inclusion Criteria:

- Clinical diagnosis of relapsing remitting MS or progressive MS who do not plan to
start a medication during the study, or on stable disease modifying medication
(interferon, glatiramer, dimethyl fumarate, teriflunomide).

- Age 30-80 years old

- Physically independent, ambulatory

- Women of childbearing potential will confirm a negative pregnancy test and must
practice effective contraception during the period of pilot study. In addition, male
subjects who have a partner of childbearing age should practice effective
contraception.

- Participants must be able to complete study procedures in the greater Philadelphia
area.

Exclusion Criteria:

- Patients are excluded who have received treatment with intravenous steroids within the
past 90 days for reasons other than MS

- Previous brain surgery that would interfere with determination of cerebral metabolism
or 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 to
interfere with the assessment of MS symptoms, or with any of the study assessments
including the PET-MRI imaging.

- Patients with evidence of a significant psychiatric disorder by history/examination
that 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 will
be evaluated on a case by case basis by the PI or study physician. These medications
include: 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 distribution
of the radiopharmaceutical in the body or brain (as determined by Investigator)

- Currently using medications that might alter the distribution of radiopharmaceuticals
in - -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) in
the body