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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01470027 |
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Date of registration:
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04/11/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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N-Acetylcysteine for Neuroprotection in Parkinson's Disease
NAC for PD |
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Scientific title:
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N-Acetylcysteine for Neuroprotection in Parkinson's Disease |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01470027 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Dikoma C. Shungu, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society
Brain Bank criteria (UKPDSBB) criteria (only for PD group
- Age 50 to 75 years
- Able to give informed consent for study participation
- Not on any medication for PD (anticholinergic agents allowed)
Exclusion Criteria:
- Unable to give informed consent
- Unable to undergo a brain MRI
- PD duration =15 years
- Receiving dopamine receptor blocking agents, including typical neuroleptics,
prochlorperazine, and metoclopramide
- Diagnosis of major depression or other axis I psychopathology
- Modified Mini-Mental Status Exam (MMSE) = 24/30
- Diagnosis of chronic or persistent illnesses that could affect oxidative stress
status, such as diabetes or congestive heart failure
- Significant concomitant medical disease limiting life expectancy to less than 12
months from study inclusion
- Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or
other neurodegenerative diseases such as Alzheimer's disease or ALS
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Intervention(s)
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Drug: N-acetylcysteine
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Drug: Placebo
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Primary Outcome(s)
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Change of Cerebral Glutathione Levels as Measured by Proton Magnetic Resonance Spectroscopy
[Time Frame: at baseline and 4 weeks after intervention start]
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Secondary Outcome(s)
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9-Hole Peg Board Test (9-HPT)
[Time Frame: at baseline and 4 weeks after intervention start]
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Parkinson's Disease Quality of Life Questionnaire (PDQLQ)
[Time Frame: at baseline and 4 weeks after intervention start]
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10-Meter Walk Test
[Time Frame: at baseline and 4 weeks after intervention start]
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Hamilton Depression Rating Scale (HAM-D)
[Time Frame: at baseline and 4 weeks after intervention start]
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Unified Parkinson's Disease Rating Scale (UPDRS) Parts I-V (Total Score Reported)
[Time Frame: at baseline and 4 weeks after intervention start]
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Beck Anxiety Inventory
[Time Frame: at baseline and 4 weeks after intervention start]
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Mini Mental State Examination (MMSE)
[Time Frame: at baseline and 4 weeks after intervention start]
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Secondary ID(s)
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1R21AG041509
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1109011912
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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