Intravenous N-acetylcysteine for the Treatment of Gaucher's Disease and Parkinson's Disease

Completed · Phase 1

Conditions studied: Parkinson's Disease, Gaucher's Disease

In brief

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.

Key facts

Study ID

NCT01427517

Run by

University of Minnesota

People needed

9

Starts

2011-07-01

Expected to finish

2012-12-01

Last updated by the study team

2019-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All participants must be 18 years or older.
• 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.
• Individuals with medically stable Parkinson's disease (in the opinion of the investigator).
• All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.
• Absence of dementia in all subjects, as determined by pre-scanning cognitive assessment.
• Control subjects who are able to undergo MRS

You may not qualify if…

• Inability to undergo MRI scanning without sedation
• Medically unstable conditions in any group as determined by the investigators
• Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
• 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
• Unable to adhere to study protocol for whatever reason

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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