Phase 2
N=47
N-Acetylcysteine for Neuroprotection in Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT01470027 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy — 3.422; 3.334; 3.745; 4.282 Ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-acetylcysteine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Weill Medical College of Cornell University
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy |
3.422; 3.334; 3.745; 4.282; 4.415; 3.901 | — |
| SECONDARY Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported) |
35.286; 31.500; 16.714; 1.000; 4.500; 3.143 | — |
| SECONDARY Mini Mental State Examination (MMSE) |
29.571; 29.857; 29.571; 29.778; 29.625; 30.000 | — |
| SECONDARY Hamilton Depression Rating Scale (HAM-D) |
3.714; 3.571; 1.857; 2.222; 1.875; 1.889 | — |
| SECONDARY 9-Hole Peg Board Test (9-HPT) |
37.026; 27.795; 28.694; 25.088; 24.593; 25.834 | — |
| SECONDARY 10-Meter Walk Test |
7.816; 7.289; 6.896; 7.253; 10.403; 7.141 | — |
| SECONDARY Beck Anxiety Inventory |
7.000; 9.000; 6.333; 3.778; 3.750; 2.625 | — |
| SECONDARY Parkinson's Disease Quality of Life Questionnaire (PDQLQ) |
134.333; 142.285; 159.833; 175.667; 171.625; 175.250 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01470027). 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.