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: August 28, 2018
• Sponsor: Weill Medical College of Cornell University
• 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

Participant Flow

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
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

Baseline Characteristics

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
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
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

Outcome Measures

1. Primary Outcome

Title	Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
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

Outcome Measure Data

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
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)
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: 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.
Time Frame	at baseline and 4 weeks after intervention start

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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)
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

Outcome Measure Data

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
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)

Adverse Events

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

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%)

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%)

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

Limitations and Caveats

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.

More Information

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
• EMail: dcs7001@med.cornell.edu

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01470027
• 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