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Physiological Effects of Nutritional Support in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease, Idiopathic Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intravenous and Oral n-acetyl cysteine
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease focused on measuring Integrative Medicine, Alternative Medicine, Complementary Medicine, Parkinson's disease, Neurodegenerative Diseases, Idiopathic Parkinson's disease, Single Photon Emission Computed Tomography (SPECT), Central Nervous System Diseases, Movement Disorders, Nervous System Diseases, Brain Diseases, Oral supplements, N-acetyl cysteine

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Oral and IV N acetyl Cysteine Cohort

Control Cohort

Arm Description

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)

Standard of Care Treatment

Outcomes

Primary Outcome Measures

Changes in the dopamine transporter (DAT) which reflects the overall health of the dopaminergic system
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan) of Dopamine Uptake

Secondary Outcome Measures

Full Information

First Posted
January 23, 2015
Last Updated
August 17, 2022
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT02445651
Brief Title
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Official Title
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
August 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Idiopathic Parkinson Disease
Keywords
Integrative Medicine, Alternative Medicine, Complementary Medicine, Parkinson's disease, Neurodegenerative Diseases, Idiopathic Parkinson's disease, Single Photon Emission Computed Tomography (SPECT), Central Nervous System Diseases, Movement Disorders, Nervous System Diseases, Brain Diseases, Oral supplements, N-acetyl cysteine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study 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.
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral and IV N acetyl Cysteine Cohort
Arm Type
Other
Arm Description
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)
Arm Title
Control Cohort
Arm Type
No Intervention
Arm Description
Standard of Care Treatment
Intervention Type
Dietary Supplement
Intervention Name(s)
Intravenous and Oral n-acetyl cysteine
Primary Outcome Measure Information:
Title
Changes in the dopamine transporter (DAT) which reflects the overall health of the dopaminergic system
Description
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan) of Dopamine Uptake
Time Frame
Baseline and 90 ± 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Monti, MD,MBA
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Study scan report will be offer to the subject after subject completes study
IPD Sharing Access Criteria
Authorized research personnel
Citations:
PubMed Identifier
27309537
Citation
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.
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Physiological Effects of Nutritional Support in Patients With Parkinson's Disease

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