Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2014
End Date:September 2015

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The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as
therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.

The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as
therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry. The
investigators' hypothesis is that repeated oral dosing of NAC will result in increased brain
and red blood cell GSH concentrations in individuals with Parkinson's disease (PD) and
healthy controls. The specific aims are to 1.) measure plasma and blood (red blood cell)
glutathione (GSH) and ratio of reduced GSH to oxidized glutathione (GSSG) in individuals
with PD and healthy controls at baseline and after four weeks of repeated high doses of oral
NAC (6000 mg/day) and 2) measure cortical GSH levels (as ascertained through MRS) in those
with PD and healthy controls at baseline and four weeks during repeated high doses of oral
NAC (6000 mg/day) simultaneously with Aim 1. This study will combine information from a
medical history, a physical examination, and disease rating scales with results obtained
using Magnetic Resonance Spectroscopy (MRS) brain scans and pharmacokinetic studies from
blood samples. This research will require 2 visits, one at baseline and one after
approximately 28 days of therapy. Participants will provide their medical history during the
first visit, and undergo a physical examination and rating scale each visit (duration: 1
hour). The first visit including the brain scans and blood collection will require
approximately 3 hours of time. The brain scan and pharmacokinetic studies for the second
visit will require approximately 8 hours of time. In total the second visit will take
roughly 9 hours.

Inclusion Criteria:

1. All participants must be 18 years or older

2. All enrollees must understand and cooperate with requirements of the study in the
opinion of the investigators and must be able to provide written informed consent

3. Individuals with medically stable Parkinson's disease (in the opinion of the
investigator)

4. All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10,
vitamin C, or vitamin E for 3 weeks prior to the study

5. Absence of dementia in all subjects

Exclusion Criteria:

1. Inability to undergo MRI scanning without sedation and other MRI counterindications,
such as metal in the body (see section 7.3)

2. Medically unstable conditions as determined by the investigators

3. Pregnant or lactating or those women of child-bearing age that are not using
acceptable forms of contraception

4. Diagnosis of asthma that is presently being treated with ANY medication, or past
history of asthma/bronchospasm resulting in an emergency room visit, hospitalization
or treatment

5. Unable to adhere to study protocol for whatever reason
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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mi
from
Minneapolis, MN
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