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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01470027
Recruitment Status : Completed
First Posted : November 10, 2011
Results First Posted : April 18, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson Disease
Interventions Drug: N-acetylcysteine
Drug: Placebo
Enrollment 50
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title N-acetylcysteine 1800mg N-acetylcysteine 3600mg Placebo
Hide Arm/Group Description

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Period Title: Overall Study
Started 16 15 16
Completed 15 14 15
Not Completed 1 1 1
Arm/Group Title 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 Total
Hide Arm/Group Description

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Total of all reporting groups
Overall Number of Baseline Participants 7 7 7 9 8 9 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 7 participants 7 participants 9 participants 8 participants 9 participants 47 participants
60.000  (5.259) 61.714  (6.264) 62.429  (2.820) 64.222  (7.807) 56.625  (5.927) 59.778  (5.995) 60.809  (6.173)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 9 participants 8 participants 9 participants 47 participants
Female
1
  14.3%
1
  14.3%
3
  42.9%
3
  33.3%
1
  12.5%
1
  11.1%
10
  21.3%
Male
6
  85.7%
6
  85.7%
4
  57.1%
6
  66.7%
7
  87.5%
8
  88.9%
37
  78.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 9 participants 8 participants 9 participants 47 participants
Hispanic or Latino
1
  14.3%
1
  14.3%
0
   0.0%
2
  22.2%
2
  25.0%
1
  11.1%
7
  14.9%
Not Hispanic or Latino
6
  85.7%
6
  85.7%
7
 100.0%
7
  77.8%
6
  75.0%
8
  88.9%
40
  85.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 9 participants 8 participants 9 participants 47 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  28.6%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
4
  44.4%
3
  37.5%
4
  44.4%
11
  23.4%
White
5
  71.4%
7
 100.0%
6
  85.7%
5
  55.6%
5
  62.5%
5
  55.6%
33
  70.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 7 participants 9 participants 8 participants 9 participants 47 participants
7 7 7 9 8 9 47
1.Primary Outcome
Title Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
Hide Description

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.

Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 6 7 7 8 6 9
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline ( In Striatum) 3.422  (0.7371) 3.334  (0.8754) 3.745  (1.418) 4.282  (0.946) 4.415  (0.928) 3.901  (0.9698)
4 weeks after intervention start ( In Striatum) 3.404  (0.7684) 3.473  (1.010) 4.105  (1.292) 4.843  (0.9884) 3.900  (0.724) 3.831  (0.8106)
Baseline ( In Occipital) 1.743  (0.4867) 1.938  (0.3415) 1.799  (0.4608) 2.190  (0.5077) 2.007  (0.395) 2.001  (0.4755)
4 weeks after intervention start ( In Occipital) 1.962  (0.5012) 2.108  (0.3788) 2.118  (0.422) 2.161  (0.4027) 1.990  (0.3344) 2.298  (0.7663)
2.Secondary Outcome
Title Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)
Hide Description

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.

Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 7 7 7 8 4 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 35.286  (15.152) 31.500  (10.782) 16.714  (4.923) 1.000  (2.071) 4.500  (2.082) 3.143  (5.429)
4 weeks after intervention start 23.857  (16.547) 24.249  (16.547) 13.857  (6.817) 0.600  (1.342) 3.000  (2.160) 1.857  (3.185)
3.Secondary Outcome
Title Mini Mental State Examination (MMSE)
Hide Description 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.
Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 7 7 7 9 8 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 29.571  (0.5345) 29.857  (0.3780) 29.571  (0.787) 29.778  (0.667) 29.625  (0.518) 30.000  (0.000)
4 weeks after intervention start 29.667  (0.516) 29.714  (0.489) 30.000  (0.000) 29.857  (0.378) 30.000  (0.000) 29.750  (0.463)
4.Secondary Outcome
Title Hamilton Depression Rating Scale (HAM-D)
Hide Description

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.

Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 7 7 7 9 8 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 3.714  (2.430) 3.571  (2.430) 1.857  (1.951) 2.222  (3.032) 1.875  (1.807) 1.889  (2.2608)
4 weeks after intervention start 4.167  (3.869) 3.857  (2.854) 1.714  (1.976) 1.286  (1.890) 0.714  (1.113) 1.222  (1.922)
5.Secondary Outcome
Title 9-Hole Peg Board Test (9-HPT)
Hide Description 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.
Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 7 7 7 9 8 9
Mean (Standard Deviation)
Unit of Measure: s (in seconds)
Baseline 37.026  (19.509) 27.795  (5.660) 28.694  (7.886) 25.088  (4.489) 24.593  (6.089) 25.834  (4.964)
4 weeks after intervention start 32.756  (7.116) 25.980  (6.231) 28.084  (9.373) 24.940  (2.995) 22.511  (6.325) 24.704  (4.566)
6.Secondary Outcome
Title 10-Meter Walk Test
Hide Description

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.

Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 7 7 7 9 8 8
Mean (Standard Deviation)
Unit of Measure: m/s (meters per second)
Baseline 7.816  (1.820) 7.289  (1.281) 6.896  (0.907) 7.253  (0.713) 10.403  (6.380) 7.141  (0.929)
4 weeks after intervention start 10.513  (7.136) 7.434  (1.389) 6.296  (0.929) 7.279  (0.643) 9.740  (5.958) 6.893  (0.937)
7.Secondary Outcome
Title Beck Anxiety Inventory
Hide Description

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.

Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 6 7 7 9 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.000  (6.782) 9.000  (5.686) 6.333  (5.046) 3.778  (4.944) 3.750  (5.365) 2.625  (3.067)
4 weeks after intervention start 3.000  (2.450) 8.286  (4.386) 5.714  (5.438) 2.429  (2.371) 5.714  (5.345) 4.333  (8.789)
8.Secondary Outcome
Title Parkinson's Disease Quality of Life Questionnaire (PDQLQ)
Hide Description

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.

Time Frame at baseline and 4 weeks after intervention start
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Overall Number of Participants Analyzed 6 7 6 9 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 134.333  (34.488) 142.285  (14.739) 159.833  (13.586) 175.667  (19.526) 171.625  (18.647) 175.250  (14.008)
4 weeks after intervention start 127.100  (45.081) 135.571  (14.010) 159.429  (17.634) 177.833  (11.565) 165.142  (17.601) 181.750  (2.964)
Time Frame Baseline (day 0) to 4 weeks after intervention start
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description

Parkinson's patient

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Parkinson's patient

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

Healthy Volunteer

N-acetylcysteine 1800mg/day for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

N-acetylcysteine 3600mg daily for 30 days

N-acetylcysteine: 900mg NAC effervescent tablets

Healthy Volunteer

Placebo effervescent tablets daily for 30 days

Placebo: effervescent tablets

All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/9 (0.00%)    
Show Serious Adverse Events Hide Serious 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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)      0/7 (0.00%)      0/9 (0.00%)      0/8 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
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
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      2/7 (28.57%)      2/7 (28.57%)      2/9 (22.22%)      2/8 (25.00%)      2/9 (22.22%)    
Cardiac disorders             
puffy face, increased heart rate * [1]  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Gastrointestinal disorders             
nausea and vomiting, loss of appetite * [2]  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/8 (0.00%)  0 1/9 (11.11%)  1
General disorders             
Headache * [3]  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 1/9 (11.11%)  1 2/8 (25.00%)  2 0/9 (0.00%)  0
Metallic taste, Occasional light-headed on standing *  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Lightheaded after exercise, daytime napping *  0/7 (0.00%)  0 0/7 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 1/9 (11.11%)  1
Musculoskeletal and connective tissue disorders             
Shoulder and neck pain * [4]  1/7 (14.29%)  1 0/7 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Nervous system disorders             
Incidental finding in MRI  [5]  0/7 (0.00%)  0 0/7 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders             
Occasional skin itching * [6]  0/7 (0.00%)  0 1/7 (14.29%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/8 (0.00%)  0 0/9 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Withdrew from study. Described "hot flash inside head"
[2]
Few days of nausea and vomiting, loss of appetite, no stomach pain
[3]
Headache, neck pain, tiredness
[4]
Doctor think it is due to a rotatory cuff
Indicates events were collected by systematic assessment
[5]
left Acom aneurysm - intervention unwarranted due to small size
[6]
Occasional skin itching
This study was limited by recruitment challenges related to identifying sufficient numbers of patients with PD who met all the eligibility criteria, especially with respect to medication status, and were willing to enter into the 4-week trial.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Dikoma C. Shungu, Professor of Physics in Radiology
Organization: Weill Cornell Medicine
Phone: 2127462481
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01470027     History of Changes
Other Study ID Numbers: 1109011912
1R21AG041509 ( U.S. NIH Grant/Contract )
First Submitted: November 4, 2011
First Posted: November 10, 2011
Results First Submitted: November 6, 2017
Results First Posted: April 18, 2018
Last Update Posted: August 28, 2018