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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01427517
Other study ID # FWA00000312-2
Secondary ID U54NS065768
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2011
Est. completion date December 2012

Study information

Verified date October 2019
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

Drug:
N-acetylcysteine
Single, intravenous administration of N-acetylcysteine

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (5)

Lead Sponsor Collaborator
University of Minnesota National Center for Advancing Translational Science (NCATS), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Neurological Disorders and Stroke (NINDS), Rare Diseases Clinical Research Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain GSH change in brain GSH levels from baseline to post-NAC administration (90 - 110 minutes) in all subjects Baseline and up to 110 minutes post-NAC administration
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