Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease
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ClinicalTrials.gov Identifier: NCT02212678 |
Recruitment Status :
Completed
First Posted : August 8, 2014
Results First Posted : May 16, 2019
Last Update Posted : May 16, 2019
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Condition or disease | Intervention/treatment | Phase |
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Parkinson Disease | Drug: N-acetylcysteine capsule | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease |
Study Start Date : | September 2014 |
Actual Primary Completion Date : | September 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: N-acetylcysteine
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
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Drug: N-acetylcysteine capsule
N-acetylcysteine capsule
Other Name: NAC |
- Glutathione (GSH) Brain Levels [ Time Frame: pre-dose and after approximately 28 days of treatment ]GSH levels in brain of all subjects at baseline and post-NAC (n-acetylcysteine) dosing as measured by magnetic resonance spectroscopy (MRS)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212678
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Paul Tuite, MD | University of Minnesota | |
Principal Investigator: | Lisa Coles, PhD | University of Minnesota |
Responsible Party: | University of Minnesota |
ClinicalTrials.gov Identifier: | NCT02212678 |
Other Study ID Numbers: |
1406M51207 123269 ( Other Identifier: FDA ) |
First Posted: | August 8, 2014 Key Record Dates |
Results First Posted: | May 16, 2019 |
Last Update Posted: | May 16, 2019 |
Last Verified: | April 2019 |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases Acetylcysteine N-monoacetylcystine |
Antiviral Agents Anti-Infective Agents Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes |