CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
N-acetylcysteine +1 moredrug
Likely dose
N-acetylcysteine 900mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01470027
NCT01470027Phase 2Completed

N-Acetylcysteine for Neuroprotection in Parkinson's Disease

Weill Medical College of Cornell University·interventional·Posted Nov 10, 2011·Updated Aug 28, 2018

In Brief

A Phase 2 clinical trial evaluating N-acetylcysteine and Placebo for Parkinson Disease. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 10, 2011
Enrollment StartJan 1, 2012
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 14.6 years ago

Interventions

N-acetylcysteinedrug

900mg NAC effervescent tablets

Placebodrug

effervescent tablets