- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01470027
N-Acetylcysteine for Neuroprotection in Parkinson's Disease (NAC for PD)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: N-acetylcysteine 1800mg
N-acetylcysteine 1800mg/day for 30 days
|
900mg NAC effervescent tablets
Other Names:
|
Active Comparator: N-acetylcysteine 3600mg
N-acetylcysteine 3600mg daily for 30 days
|
900mg NAC effervescent tablets
Other Names:
|
Placebo Comparator: Placebo
Placebo effervescent tablets daily for 30 days
|
effervescent tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
Time Frame: at baseline and 4 weeks after intervention start
|
In vivo brain GSH measured with 1H MRS in the unmedicated patients with idiopathic PD and in sex- and age-matched healthy controls prior to and following 4 weeks supplementation with either placebo, 1800mg/day or 3600 mg/day of NAC. Striatal and occipital cortex glutathione levels as measured in vivo by 1H MRS at baseline and following 4 weeks of treatment with placebo, 1800mg NAC/day and 3600mg NAC/day. The area under the GSH spectral peak was obtained by frequency-domain fitting of the GSH resonance in the edited spectrum to a pseudo-Voigt lineshape function using a robust and highly optimized public-domain Levenberg-Marquardt nonlinear least-squares minimization routine. The resulting peak areas were then expressed as ratios relative to the synchronously acquired and similarly fitted unsuppressed voxel water signal. |
at baseline and 4 weeks after intervention start
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)
Time Frame: at baseline and 4 weeks after intervention start
|
The UPDRS is considered the gold standard for determining disease severity and progression in patients with Parkinson's disease. It consists of the following five elements:
A total of 199 points are possible for UPDRS, with 199 representing the worst disability and 0 no disability. |
at baseline and 4 weeks after intervention start
|
Mini Mental State Examination (MMSE)
Time Frame: at baseline and 4 weeks after intervention start
|
The MMSE is a brief questionnaire-based test that is used to screen for cognitive impairment.
Domains tested are orientation to time and place, registration, attention and calculation, recall, language, repetition and complex commands.
Scores lower than 25/30 points indicate mild (21-24 points), moderate (10-20 points) or severe (<10 points) cognitive impairment, but scores may need to be corrected for educational attainment, age and interfering impairments such as motor deficits that affect drawing skills.
|
at baseline and 4 weeks after intervention start
|
Hamilton Depression Rating Scale (HAM-D)
Time Frame: at baseline and 4 weeks after intervention start
|
The Hamilton Depression Rating Scale (HAM-D) is a 21-item instrument designed to measure the severity of illness in adults already diagnosed as having depression. The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It is clinician-administered and requires 15 to 20 minutes complete the interview and score the results. Although the HAM-D form lists 21 items, the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The minimum score is 0 and maximum score is 50. The scale has been widely used in clinical practice and become a standard in pharmaceutical trials. HAM-D Scoring Instructions are following: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression; ≥ 23 = Very Severe Depression. |
at baseline and 4 weeks after intervention start
|
9-Hole Peg Board Test (9-HPT)
Time Frame: at baseline and 4 weeks after intervention start
|
The 9-HPT is a standardized, quantitative timed test of upper extremity motor function.
Individuals are asked to place and remove nine pegs, one at a time, from nine holes in a board as quickly as possible.
The task is performed twice with the dominant and twice with the non-dominant hand, and the average time to complete the task once is calculated for each hand.
The 9-HPT has a high inter- and intra-rater reliability, is validated and is sensitive to detect minor impairments of hand function.
|
at baseline and 4 weeks after intervention start
|
10-Meter Walk Test
Time Frame: at baseline and 4 weeks after intervention start
|
The 10-meter walk test is a standardized, quantitative timed test of lower body motor function. The maximal gait speed is measured during a 10-meter walk. The task will be performed three times and the average time to complete the task once will be recorded. The 10-meter walk test is a reliable and sensitive measure of gait function in elderly individuals and PD patients. Cut-off values: < 0.4 m/s more likely to be household ambulators; 0.4 - 0.8 m/s limited community ambulators; > 0.8 m/s community ambulators. |
at baseline and 4 weeks after intervention start
|
Beck Anxiety Inventory
Time Frame: at baseline and 4 weeks after intervention start
|
The Beck Anxiety Inventory (BAI) is a clinician-administered and validated instrument to discriminate anxiety from depression. The standardized BAI cutoffs are: 0-9: minimal anxiety; 10-16: mild anxiety; 17-29: moderate anxiety; 30-63: severe anxiety. |
at baseline and 4 weeks after intervention start
|
Parkinson's Disease Quality of Life Questionnaire (PDQLQ)
Time Frame: at baseline and 4 weeks after intervention start
|
The Parkinson's Disease Quality of Life Questionnaire is a self completion PRO designed to address aspects of functioning and well-being for those affected by Parkinson's disease. The Parkinson's Disease Quality of Life Questionnaire is coded on a scale of 0 to 185, with 185 indicating perfect health and 0 indicating very poor health. |
at baseline and 4 weeks after intervention start
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Protective Agents
- Respiratory System Agents
- Antioxidants
- Antidotes
- Free Radical Scavengers
- Expectorants
- Acetylcysteine
- N-monoacetylcystine
Other Study ID Numbers
- 1109011912
- 1R21AG041509 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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