Trial Outcomes & Findings for N-Acetylcysteine for Neuroprotection in Parkinson's Disease (NCT NCT01470027)
NCT ID: NCT01470027
Last Updated: 2018-08-28
Results Overview
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.
COMPLETED
PHASE1/PHASE2
50 participants
at baseline and 4 weeks after intervention start
2018-08-28
Participant Flow
Enrollment for this pilot clinical study started in March 2012, as the end of the study in August 2016, 23 of 30 PD patients and 27 of 30 healthy volunteers (HV) subjects - a total 50- had participated in the study. All subjects enrolled at the Weill Cornell Parkinson's Disease and Movement Disorders Institute, led by the study neurologist.
A total of 50 subjects enrolled into the study (23 PD patients and 27 HV subjects). Only 21 patients with PD and 26 HV subjects underwent the baseline assessments. Two PD patients and 1 HV subject were excluded from the study before assignment to groups. All exclusion were unrelated to the study protocol.
Participant milestones
| Measure |
N-acetylcysteine 1800mg
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
16
|
|
Overall Study
COMPLETED
|
15
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
N-Acetylcysteine for Neuroprotection in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=9 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.000 Years
STANDARD_DEVIATION 5.259 • n=5 Participants
|
61.714 Years
STANDARD_DEVIATION 6.264 • n=7 Participants
|
62.429 Years
STANDARD_DEVIATION 2.820 • n=5 Participants
|
64.222 Years
STANDARD_DEVIATION 7.807 • n=4 Participants
|
56.625 Years
STANDARD_DEVIATION 5.927 • n=21 Participants
|
59.778 Years
STANDARD_DEVIATION 5.995 • n=8 Participants
|
60.809 Years
STANDARD_DEVIATION 6.173 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
40 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
9 participants
n=4 Participants
|
8 participants
n=21 Participants
|
9 participants
n=8 Participants
|
47 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: at baseline and 4 weeks after intervention startPopulation: The number of participants in the Participant Flow module is different from the Overall Number of Participants for brain GSH levels because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment GSH values were available only for 43 subjects, whose data were included in the analysis.
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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=6 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=6 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=9 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
Baseline ( In Striatum)
|
3.422 Ratio
Standard Deviation 0.7371
|
3.334 Ratio
Standard Deviation 0.8754
|
3.745 Ratio
Standard Deviation 1.418
|
4.282 Ratio
Standard Deviation 0.946
|
4.415 Ratio
Standard Deviation 0.928
|
3.901 Ratio
Standard Deviation 0.9698
|
|
Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
4 weeks after intervention start ( In Striatum)
|
3.404 Ratio
Standard Deviation 0.7684
|
3.473 Ratio
Standard Deviation 1.010
|
4.105 Ratio
Standard Deviation 1.292
|
4.843 Ratio
Standard Deviation 0.9884
|
3.900 Ratio
Standard Deviation 0.724
|
3.831 Ratio
Standard Deviation 0.8106
|
|
Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
Baseline ( In Occipital)
|
1.743 Ratio
Standard Deviation 0.4867
|
1.938 Ratio
Standard Deviation 0.3415
|
1.799 Ratio
Standard Deviation 0.4608
|
2.190 Ratio
Standard Deviation 0.5077
|
2.007 Ratio
Standard Deviation 0.395
|
2.001 Ratio
Standard Deviation 0.4755
|
|
Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
4 weeks after intervention start ( In Occipital)
|
1.962 Ratio
Standard Deviation 0.5012
|
2.108 Ratio
Standard Deviation 0.3788
|
2.118 Ratio
Standard Deviation 0.422
|
2.161 Ratio
Standard Deviation 0.4027
|
1.990 Ratio
Standard Deviation 0.3344
|
2.298 Ratio
Standard Deviation 0.7663
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startPopulation: The number of participants in the Participant Flow module is different from the Overall Number of Participants for Unified Parkinson's Disease Rating Scale (UPDRS) because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment UPDRS were available only for 40 subjects, whose data were included in the analysis.
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: 1. Evaluation of mentation, behavior and mood. 2. Self evaluation of the activities of daily living (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, etc. 3. Motor evaluation by a clinician. 4. Hoehn and Yahr scale (Hoehn 1967) for the description of the overall disease severity in PD with 8 stages. 5. 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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=4 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=7 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)
Baseline
|
35.286 units on a scale
Standard Deviation 15.152
|
31.500 units on a scale
Standard Deviation 10.782
|
16.714 units on a scale
Standard Deviation 4.923
|
1.000 units on a scale
Standard Deviation 2.071
|
4.500 units on a scale
Standard Deviation 2.082
|
3.143 units on a scale
Standard Deviation 5.429
|
|
Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)
4 weeks after intervention start
|
23.857 units on a scale
Standard Deviation 16.547
|
24.249 units on a scale
Standard Deviation 16.547
|
13.857 units on a scale
Standard Deviation 6.817
|
0.600 units on a scale
Standard Deviation 1.342
|
3.000 units on a scale
Standard Deviation 2.160
|
1.857 units on a scale
Standard Deviation 3.185
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startThe 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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=9 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Mini Mental State Examination (MMSE)
Baseline
|
29.571 units on a scale
Standard Deviation 0.5345
|
29.857 units on a scale
Standard Deviation 0.3780
|
29.571 units on a scale
Standard Deviation 0.787
|
29.778 units on a scale
Standard Deviation 0.667
|
29.625 units on a scale
Standard Deviation 0.518
|
30.000 units on a scale
Standard Deviation 0.000
|
|
Mini Mental State Examination (MMSE)
4 weeks after intervention start
|
29.667 units on a scale
Standard Deviation 0.516
|
29.714 units on a scale
Standard Deviation 0.489
|
30.000 units on a scale
Standard Deviation 0.000
|
29.857 units on a scale
Standard Deviation 0.378
|
30.000 units on a scale
Standard Deviation 0.000
|
29.750 units on a scale
Standard Deviation 0.463
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startThe 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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=9 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Hamilton Depression Rating Scale (HAM-D)
Baseline
|
3.714 units on a scale
Standard Deviation 2.430
|
3.571 units on a scale
Standard Deviation 2.430
|
1.857 units on a scale
Standard Deviation 1.951
|
2.222 units on a scale
Standard Deviation 3.032
|
1.875 units on a scale
Standard Deviation 1.807
|
1.889 units on a scale
Standard Deviation 2.2608
|
|
Hamilton Depression Rating Scale (HAM-D)
4 weeks after intervention start
|
4.167 units on a scale
Standard Deviation 3.869
|
3.857 units on a scale
Standard Deviation 2.854
|
1.714 units on a scale
Standard Deviation 1.976
|
1.286 units on a scale
Standard Deviation 1.890
|
0.714 units on a scale
Standard Deviation 1.113
|
1.222 units on a scale
Standard Deviation 1.922
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startPopulation: The measurement used for the 9-HPT is the average of time needed to complete the task with the dominant and non-dominant hand recorded in seconds. The presence of PD is expected to produce higher test times in seconds.
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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=9 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
9-Hole Peg Board Test (9-HPT)
Baseline
|
37.026 s (in seconds)
Standard Deviation 19.509
|
27.795 s (in seconds)
Standard Deviation 5.660
|
28.694 s (in seconds)
Standard Deviation 7.886
|
25.088 s (in seconds)
Standard Deviation 4.489
|
24.593 s (in seconds)
Standard Deviation 6.089
|
25.834 s (in seconds)
Standard Deviation 4.964
|
|
9-Hole Peg Board Test (9-HPT)
4 weeks after intervention start
|
32.756 s (in seconds)
Standard Deviation 7.116
|
25.980 s (in seconds)
Standard Deviation 6.231
|
28.084 s (in seconds)
Standard Deviation 9.373
|
24.940 s (in seconds)
Standard Deviation 2.995
|
22.511 s (in seconds)
Standard Deviation 6.325
|
24.704 s (in seconds)
Standard Deviation 4.566
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startPopulation: The number of participants in the Participant Flow module is different from the Overall Number of Participants for 10-Meter Walk Test because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment 10-Meter Walk Test score were available only for 46 subjects, whose data were included in the analysis.
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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=8 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
10-Meter Walk Test
Baseline
|
7.816 m/s (meters per second)
Standard Deviation 1.820
|
7.289 m/s (meters per second)
Standard Deviation 1.281
|
6.896 m/s (meters per second)
Standard Deviation 0.907
|
7.253 m/s (meters per second)
Standard Deviation 0.713
|
10.403 m/s (meters per second)
Standard Deviation 6.380
|
7.141 m/s (meters per second)
Standard Deviation 0.929
|
|
10-Meter Walk Test
4 weeks after intervention start
|
10.513 m/s (meters per second)
Standard Deviation 7.136
|
7.434 m/s (meters per second)
Standard Deviation 1.389
|
6.296 m/s (meters per second)
Standard Deviation 0.929
|
7.279 m/s (meters per second)
Standard Deviation 0.643
|
9.740 m/s (meters per second)
Standard Deviation 5.958
|
6.893 m/s (meters per second)
Standard Deviation 0.937
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startPopulation: The number of participants in the Participant Flow module is different from the Overall Number of Participants for Beck Anxiety Inventory (BAI) test because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment BAI scores were available only for 45 subjects, whose data were included in the analysis.
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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=6 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=8 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Beck Anxiety Inventory
Baseline
|
7.000 units on a scale
Standard Deviation 6.782
|
9.000 units on a scale
Standard Deviation 5.686
|
6.333 units on a scale
Standard Deviation 5.046
|
3.778 units on a scale
Standard Deviation 4.944
|
3.750 units on a scale
Standard Deviation 5.365
|
2.625 units on a scale
Standard Deviation 3.067
|
|
Beck Anxiety Inventory
4 weeks after intervention start
|
3.000 units on a scale
Standard Deviation 2.450
|
8.286 units on a scale
Standard Deviation 4.386
|
5.714 units on a scale
Standard Deviation 5.438
|
2.429 units on a scale
Standard Deviation 2.371
|
5.714 units on a scale
Standard Deviation 5.345
|
4.333 units on a scale
Standard Deviation 8.789
|
SECONDARY outcome
Timeframe: at baseline and 4 weeks after intervention startPopulation: The number of participants in the Participant Flow module is different from the Overall Number of Participants for PDQLQ because of the total sample of 47 subjects enrolled in the study, baseline and post-treatment PDQLQ scores were available only for 43 subjects, whose data were included in the analysis.
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.
Outcome measures
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=6 Participants
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 Participants
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=6 Participants
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 Participants
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 Participants
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=8 Participants
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Parkinson's Disease Quality of Life Questionnaire (PDQLQ)
Baseline
|
134.333 units on a scale
Standard Deviation 34.488
|
142.285 units on a scale
Standard Deviation 14.739
|
159.833 units on a scale
Standard Deviation 13.586
|
175.667 units on a scale
Standard Deviation 19.526
|
171.625 units on a scale
Standard Deviation 18.647
|
175.250 units on a scale
Standard Deviation 14.008
|
|
Parkinson's Disease Quality of Life Questionnaire (PDQLQ)
4 weeks after intervention start
|
127.100 units on a scale
Standard Deviation 45.081
|
135.571 units on a scale
Standard Deviation 14.010
|
159.429 units on a scale
Standard Deviation 17.634
|
177.833 units on a scale
Standard Deviation 11.565
|
165.142 units on a scale
Standard Deviation 17.601
|
181.750 units on a scale
Standard Deviation 2.964
|
Adverse Events
N-acetylcysteine 1800mg - Parkinson's Patient
N-acetylcysteine 3600mg -Parkinson's Patient
Placebo -Parkinson's Patient
N-acetylcysteine 1800mg - Healthy Volunteer
N-acetylcysteine 3600mg -Healthy Volunteer
Placebo -Healthy Volunteer
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
N-acetylcysteine 1800mg - Parkinson's Patient
n=7 participants at risk
Parkinson's patient
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Parkinson's Patient
n=7 participants at risk
Parkinson's patient
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Parkinson's Patient
n=7 participants at risk
Parkinson's patient
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
N-acetylcysteine 1800mg - Healthy Volunteer
n=9 participants at risk
Healthy Volunteer
N-acetylcysteine 1800mg/day for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
N-acetylcysteine 3600mg -Healthy Volunteer
n=8 participants at risk
Healthy Volunteer
N-acetylcysteine 3600mg daily for 30 days
N-acetylcysteine: 900mg NAC effervescent tablets
|
Placebo -Healthy Volunteer
n=9 participants at risk
Healthy Volunteer
Placebo effervescent tablets daily for 30 days
Placebo: effervescent tablets
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
nausea and vomiting, loss of appetite
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
11.1%
1/9 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
11.1%
1/9 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
|
General disorders
Headache
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
14.3%
1/7 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
11.1%
1/9 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
25.0%
2/8 • Number of events 2 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
|
Nervous system disorders
Incidental finding in MRI
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
14.3%
1/7 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
|
Musculoskeletal and connective tissue disorders
Shoulder and neck pain
|
14.3%
1/7 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
|
Skin and subcutaneous tissue disorders
Occasional skin itching
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
14.3%
1/7 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
|
General disorders
Metallic taste, Occasional light-headed on standing
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
14.3%
1/7 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
|
Cardiac disorders
puffy face, increased heart rate
|
14.3%
1/7 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
|
General disorders
Lightheaded after exercise, daytime napping
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/7 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/9 • Baseline (day 0) to 4 weeks after intervention start
|
0.00%
0/8 • Baseline (day 0) to 4 weeks after intervention start
|
11.1%
1/9 • Number of events 1 • Baseline (day 0) to 4 weeks after intervention start
|
Additional Information
Dr. Dikoma C. Shungu, Professor of Physics in Radiology
Weill Cornell Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place