Phase 2
N=8
Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT02212678 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Glutathione (GSH) Brain Levels — 0.93; 0.99 mM
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine capsule (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glutathione (GSH) Brain Levels |
0.93; 0.99 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02212678). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.