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

August 17, 2022 updated by: Thomas Jefferson University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Cohort
Standard of Care Treatment
Other: 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)
Dietary supplement: Intravenous and Oral n-acetyl cysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and 90 ± 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Daniel A Monti, MD,MBA, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

August 4, 2022

Study Completion (Actual)

August 4, 2022

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 15, 2015

Study Record Updates

Last Update Posted (Actual)

August 19, 2022

Last Update Submitted That Met QC Criteria

August 17, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14D.141

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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