Parkinson's Disease Clinical Trial
Official title:
Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease
The investigators are interested in determining if the investigators are able to detect changes in brain chemistry using Magnetic Resonance Spectroscopy (MRS) in individuals with Parkinson's disease (PD), those with Gaucher's disease (GD), and those without neurological disorders (healthy controls) when they are given the antioxidant N-acetylcysteine (NAC). This study will combine information from a medical history, a physical examination and disease rating scales with results obtained using MRS brain scans and pharmacokinetic studies from blood samples. This research will require 1 visit that will require about 4 to 5 hours of time. During this study, participants will provide their medical history, be examined and undergo a rating scale for about one hour; the brain scan and pharmacokinetic studies will require 1.5-2 hours of time; in total the study will take about 4-5 hours.
Oxidative stress is implicated in the pathogenesis of a number of neurodegenerative diseases
such as Parkinson's disease (PD). Further, levels of glutathione (GSH), a prevalent
endogenous antioxidant, are decreased in the postmortem substantia nigra (SN) of individuals
with PD, indicating increased oxidative stress, although this has yet not been confirmed in
vivo. Increases in intracellular oxidative stress have also been observed in primary
fibroblast cultures obtained from patients with GD, where enzyme replacement therapy resulted
in increases in total GSH. The hypothesis that oxidative stress plays a key role in the
neurodegeneration associated with PD suggests that antioxidants may be useful in altering
disease progression.
N-acetylcysteine (NAC) is a well-known antioxidant that is thought to act both as a free
radical scavenger and as a cysteine donor for the synthesis of GSH. NAC may be beneficial in
the treatment of PD and GD. Magnetic resonance spectroscopy (MRS) methods may be able to
determine if there are effects from NAC on central nervous system GSH levels. In addition,
use of red blood cell (RBC) measurements of GSH, if correlated with brain concentrations,
could serve as an easily measured biomarker to help characterize and monitor response to
therapy. The investigators therefore propose to conduct a study of the effect of a single,
intravenous dose of NAC on central (brain) measures of GSH and peripheral (RBC) measures of
GSH in people with PD and healthy controls, through the use of simultaneous MRS techniques
and pharmacokinetic studies. The investigators hypothesis and specific aims are as follows:
Hypothesis: RBC and brain GSH concentrations will increase following oral NAC administration
in individuals with Parkinson's disease (PD), Gaucher's disease (GD), and control
participants.
Specific Aims:
1. Quantitate baseline plasma and red blood cell GSH concentrations in those with PD and GD
and controls; and characterize NAC and GSH pharmacokinetics after a single intravenous
NAC administration.
2. Quantitate brain GSH levels (as ascertained through MRS) in those with PD and GD and
controls at baseline and after a single intravenous NAC administration simultaneously
with Aim 1.
3. Construct a pharmacokinetic model to evaluate the relationship between peripheral
(plasma and RBC) and central (brain) GSH measurements.
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