Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
2 other identifiers
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 parkinson-disease
Started Sep 2014
Shorter than P25 for phase_2 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 8, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
May 16, 2019
CompletedMay 16, 2019
April 1, 2019
1 year
August 4, 2014
April 23, 2019
April 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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)
pre-dose and after approximately 28 days of treatment
Study Arms (1)
N-acetylcysteine
EXPERIMENTALSubjects 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
Interventions
Eligibility Criteria
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 NAC, glutathione, coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study
- Absence of dementia in all subjects
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lisa Coles, MS, PhD
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Tuite, MD
University of Minnesota
- PRINCIPAL INVESTIGATOR
Lisa Coles, PhD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 8, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
May 16, 2019
Results First Posted
May 16, 2019
Record last verified: 2019-04