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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine capsule
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

N-acetylcysteine

Arm Description

Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days

Outcomes

Primary Outcome Measures

Glutathione (GSH) Brain Levels
GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)

Secondary Outcome Measures

Full Information

First Posted
August 4, 2014
Last Updated
April 23, 2019
Sponsor
University of Minnesota
Collaborators
Parkinson's Disease Society of the United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02212678
Brief Title
Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Official Title
Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Parkinson's Disease Society of the United Kingdom

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Experimental
Arm Description
Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine capsule
Other Intervention Name(s)
NAC
Intervention Description
N-acetylcysteine capsule
Primary Outcome Measure Information:
Title
Glutathione (GSH) Brain Levels
Description
GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)
Time Frame
pre-dose and after approximately 28 days of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 NAC, glutathione, coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study Absence of dementia in all subjects Exclusion Criteria: Inability to undergo MRI scanning without sedation and other MRI counterindications, such as metal in the body (see section 7.3) Medically unstable conditions 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Tuite, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lisa Coles, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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