N-Acetylcysteine for Neuroprotection in Parkinson's Disease (NAC for PD)
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ClinicalTrials.gov Identifier: NCT01470027 |
Recruitment Status :
Completed
First Posted : November 10, 2011
Results First Posted : April 18, 2018
Last Update Posted : August 28, 2018
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Study Type | Interventional |
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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 |
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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%
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10 21.3%
|
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Male |
6 85.7%
|
6 85.7%
|
4 57.1%
|
6 66.7%
|
7 87.5%
|
8 88.9%
|
37 78.7%
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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%
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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 |
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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 |
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 |