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Trial record 1 of 1 for:    NCT02445651
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Physiological Effects of Nutritional Support in Patients With Parkinson's Disease

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: NCT02445651
Recruitment Status : Active, not recruiting
First Posted : May 15, 2015
Last Update Posted : July 14, 2020
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE January 23, 2015
First Posted Date  ICMJE May 15, 2015
Last Update Posted Date July 14, 2020
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
Changes in the dopamine transporter (DAT) which reflects the overall health of the dopaminergic system [ Time Frame: Baseline and 90 ± 30 days ]
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan) of Dopamine Uptake
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Official Title  ICMJE Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Brief Summary

Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects more than a million Americans. It's most prominent pathology is the degeneration of dopaminergic neurons in the brain. It is believed that oxidative stress and inflammation play an important role in the pathophysiology of Parkinson's disease as well.

The object of this study is to evaluate whether nutritional supplementation with compounds that have been shown to have either anti- inflammatory, or antioxidant effects, might support brain function in patients with Parkinson's disease, particularly in regards to the dopamine system. Enrolled patients will be randomly assigned to receive oral and intravenous n-acetyl cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan) single photon emission computed tomography (SPECT) to measure dopamine function, magnetic resonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, and neurological measures to assess clinical symptoms, in patients with PD. Subjects will receive a DaTSCAN and MRS initially and after completing the supplement or NAC regimen.

Detailed Description The study consists of two arms. The first arm of this study will receive intravenous and oral NAC, which is a strong antioxidant that increases brain glutathione, which may be beneficial in PD. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement and also is available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. Laboratory studies have displayed some benefits to use of NAC, such as its potential to counteract intracellular damage that leads to dopaminergic neuron death. It also has the potential to reduce markers of oxidative damage, protect against dopamine cell death from MPTP toxicity, and to increase glutathione in blood, which might be useful in preventing oxidative damage in PD patients.The second arm will be a waitlist control receiving standard PD care. It should be noted that both arms will receive standard PD care which will be augmented with NAC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
This is an Open Label study. Randomization will occur via a 2:1 ratio of the NAC group and the waitlist control groups using the method of random permuted blocks with random block sizes without stratification. 28 subjects in the NAC arm and 14 subjects have been enrolled in the standard of care arm.
Primary Purpose: Supportive Care
Condition  ICMJE
  • Parkinson Disease
  • Idiopathic Parkinson Disease
Intervention  ICMJE Dietary Supplement: Intravenous and Oral n-acetyl cysteine
Study Arms  ICMJE
  • Oral and IV N acetyl Cysteine Cohort
    Administration of Intravenous (IV) and Oral N-acetyl Cysteine (NAC) Intervention: IV NAC infusion: Dose: 50mg in 200ml of D5W, frequency: over one hour 1 x per week for 90 days ± 30 days AND Oral N-acetyl Cysteine - one 600 mg tablet 2 x per day (on days IV N-acetyl cysteine is not administered)
    Intervention: Dietary Supplement: Intravenous and Oral n-acetyl cysteine
  • No Intervention: Control Cohort
    Standard of Care Treatment
Publications * Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Cai J, Wei X, Bazzan AJ, Zhong L, Bowen B, Intenzo CM, Iacovitti L, Newberg AB. N-Acetyl Cysteine May Support Dopamine Neurons in Parkinson's Disease: Preliminary Clinical and Cell Line Data. PLoS One. 2016 Jun 16;11(6):e0157602. doi: 10.1371/journal.pone.0157602. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 6, 2021
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical Diagnosis of Parkinson's disease
  • Subject is between 30 - 80 years of age
  • Subject has a Hoehn and Yahr score of I - II inclusive
  • Subject is on stable or on antiparkinsonian medication for at least a month
  • Women of Childbearing potential will confirm a negative pregnancy test

Exclusion Criteria:

  • Subject is allergic to iodine, cobalt, or any of the supplements that will be given in the study
  • Subject has had previous brain surgery
  • Subject has a score of 25 or less on Mini-Mental Status examination
  • Subject is wheelchair-bound or bed-ridden; non ambulatory
  • Subject has intracranial abnormalities that may complicate interpretation of the brain scans(e.g., stroke, tumor, vascular abnormality affecting the target area)
  • Subject has a history of head trauma with loss of consciousness greater than 48 hours
  • Subject has any medical disorder or physical condition that could reasonably be expected to interfere with the assessment of parkinsonian syndrome symptoms, or with any of the study assessments including the SPECT imaging.
  • Subject has evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study
  • Subject has a current alcohol or drug abuse
  • Subject is pregnant or lactating
  • Subject is enrolled in active clinical (drug or device) trial within the prior 30 days
  • Subject is pending surgery during the course of the study
  • History of very low blood pressure
  • History of thrombocytopenia or clotting disorders
  • Cancer patients receiving active chemotherapy
  • History of active gallstone problems or a bile duct obstruction
  • History of uncontrolled diabetes, asthma, gastroesophageal reflex disease, or thyroid
  • History of severe kidney disease (if the patient reports this problem, a serum creatinine will be checked to assess GFR; if it is less than 30, the patient will be excluded)
  • History of Leber's disease, a hereditary eye disease
  • History of uncontrolled hypercalcemia
  • History of active sarcoidosis, histoplasmosis, or lymphoma
  • Patients taking medication that might interact with the supplements involved in this study will be evaluated on a case-by-case basis by PI study physician
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02445651
Other Study ID Numbers  ICMJE 14D.141
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After each participant completes the study, study scan data will be shared with co-investigators; participants may receive a copy of each scan after study completion.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Study scan report will be offer to the subject after subject completes study
Access Criteria: Authorized research personnel
Responsible Party Thomas Jefferson University
Study Sponsor  ICMJE Thomas Jefferson University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniel A Monti, MD,MBA Thomas Jefferson University
PRS Account Thomas Jefferson University
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP