N-Acetylcysteine for Neuroprotection in Parkinson's Disease

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

The overall objective of this developmental/exploratory study is to use noninvasive proton magnetic resonance spectroscopy (1H MRS) to assess (a) whether brain levels of the antioxidant glutathione (GSH) are decreased in vivo, as has been found in postmortem brain, in 30 patients with Parkinson's disease (PD) compared to matched controls; (b) whether GSH levels in PD brain increase significantly following 30 days of daily supplementation with 1800mg or 3600mg of N-acetylcysteine (NAC) compared to placebo and to baseline, and (c) whether any such increases in brain GSH would be dose-dependent and be associated with a change in the participants' oxidative stress profiles. In addition, a clinical assessment battery, including quantitative tests of motor function, will be performed to investigate potential associations between the NAC intervention, brain GSH levels, oxidative stress markers, and clinical presentation. If successful, this study will represent the first objective documentation of whether there is a GSH deficit in living PD brain that dietary NAC supplementation can mitigate, thereby providing a compelling justification for investigating such neuroprotective strategies in larger controlled clinical trials.

Key facts

Study ID

NCT01470027

Run by

Weill Medical College of Cornell University

People needed

50

Starts

2012-01-01

Expected to finish

2016-08-01

Last updated by the study team

2018-08-28

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society Brain Bank criteria (UKPDSBB) criteria (only for PD group
• Age 50 to 75 years
• Able to give informed consent for study participation
• Not on any medication for PD (anticholinergic agents allowed)

You may not qualify if…

• Unable to give informed consent
• Unable to undergo a brain MRI
• PD duration ≥15 years
• Receiving dopamine receptor blocking agents, including typical neuroleptics, prochlorperazine, and metoclopramide
• Diagnosis of major depression or other axis I psychopathology
• Modified Mini-Mental Status Exam (MMSE) ≤ 24/30
• Diagnosis of chronic or persistent illnesses that could affect oxidative stress status, such as diabetes or congestive heart failure
• Significant concomitant medical disease limiting life expectancy to less than 12 months from study inclusion
• Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease or ALS

Where it is running

• Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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