N-Acetylcysteine for Neuroprotection in Parkinson's Disease (NAC for PD)
|ClinicalTrials.gov Identifier: NCT01470027|
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : April 18, 2018
Last Update Posted : April 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Drug: N-acetylcysteine Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||N-Acetylcysteine for Neuroprotection in Parkinson's Disease|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Active Comparator: N-acetylcysteine 1800mg
N-acetylcysteine 1800mg/day for 30 days
900mg NAC effervescent tablets
Other Name: NAC
Active Comparator: N-acetylcysteine 3600mg
N-acetylcysteine 3600mg daily for 30 days
900mg NAC effervescent tablets
Other Name: NAC
Placebo Comparator: Placebo
Placebo effervescent tablets daily for 30 days
- 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.
- 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:
- Evaluation of mentation, behavior and mood.
- Self evaluation of the activities of daily living (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, etc.
- Motor evaluation by a clinician.
- Hoehn and Yahr scale (Hoehn 1967) for the description of the overall disease severity in PD with 8 stages.
- Schwab and England activities of daily living scale (Schwab and England 1969) for the estimation of the general abilities in PD patients. The Schwab and England ADL scale is graduated in 10% steps with 100% indicating complete independence and 0% indicating an individual in whom the vegetative functions are completely impaired.
A total of 199 points are possible for UPDRS, with 199 representing the worst disability and 0 no disability.
- 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.
- 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.
- 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.
- 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.
< 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470027
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10021|
|Principal Investigator:||Dikoma C. Shungu, Ph.D.||Weill Medical College of Cornell University|