N-Acetylcysteine for Neuroprotection in Parkinson's Disease (NAC for PD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dikoma C. Shungu, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01470027
First received: November 4, 2011
Last updated: January 20, 2012
Last verified: November 2011
  Purpose

The overall objective of this developmental/exploratory study is to use noninvasive proton magnetic resonance spectroscopy (1H MRS) to determine (a) whether levels of the antioxidant glutathione (GSH) are decreased in vivo, as has been found in postmortem brain, in the brain of 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.


Condition Intervention Phase
Parkinson Disease
Drug: N-acetylcysteine
Drug: Placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-Acetylcysteine for Neuroprotection in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • change of cerebral glutathione levels as measured by proton magnetic resonance spectroscopy [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale Parts I-V [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory Questionnaire [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • 9-Hole Peg Board Test [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • 10-Meter Walk Test [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • oxidative stress markers in cerebrospinal fluid [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • Questionnaire for Impulsive Compulsive Disorders in PD [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • Beck Anxiety Inventory [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]
  • PD quality of life questionnaire [ Time Frame: at baseline and 4 weeks after intervention start ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N-acetylcysteine 1800mg
N-acetylcysteine 1800mg/day for 30 days
Drug: N-acetylcysteine
900mg NAC effervescent tablets
Other Name: NAC
Active Comparator: N-acetylcysteine 3600mg
N-acetylcysteine 3600mg daily for 30 days
Drug: N-acetylcysteine
900mg NAC effervescent tablets
Other Name: NAC
Placebo Comparator: Placebo
Placebo effervescent tablets daily for 30 days
Drug: Placebo
effervescent tablets

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01470027

Contacts
Contact: Claire Henchcliffe, MD DPhil 212-746 ext 2584 clh2007@med.cornell.edu
Contact: Dikoma C Shungu, PhD 212-746 ext 2481 dcs7001@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Principal Investigator: Dikoma C. Shungu, Ph.D.         
Sub-Investigator: Claire Henchcliffe, MD DPhil         
Sub-Investigator: Xiangling Mao, MS         
Principal Investigator: Nora Weiduschat, MD MPH         
Sub-Investigator: Halinder Mangat, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Dikoma C. Shungu, Ph.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Dikoma C. Shungu, Professor of Physics in Radiology, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01470027     History of Changes
Other Study ID Numbers: 1109011912, 1R21AG041509-01
Study First Received: November 4, 2011
Last Updated: January 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
magnetic resonance spectroscopy
N-acetylcysteine
antioxidant
glutathione

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 20, 2014