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

NCT02445651 | Completed Results

• 1 other identifier: 14D.141
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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 oral and IV N acetyl cysteine 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 (IV) n-acetyl cysteine (NAC), a control group of standard PD care, or an oral supplement group who will receive Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin. (Please note, the Oral Supplements arm, was amended and not included in analysis. This study utilized 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 received a DaTSCAN and MRS initially and after completing oral and IV NAC regimen. Subjects in the control group received pre and post DaTScans and MRS and similar evaluations to the Dietary Supplement oral and IV NAC group.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Distribution Volume Ratio

  Distribution Volume Ratio reflects Iofluvane absorption by the dopamine transporters (Dopamine Uptake) that reflects binding in the dopamine transporter (DAT) overall. Striatal Binding Ratio in the regions of interest (ROI), caudate, putamen, and midbrain Serotonin Transporter (SERT) binding and Dopamine Transporter (5-HTT) Binding was measured during Single Photon Emission Computed Tomography (SPECT) Brain Imaging with DATScan (Iofluvane). Regions of interest in the caudate, putamen and in midbrain SERT binding are affected in Parkinson's Disease. Less dopamine transporter binding (lower number) indicates less activated dopamine transporters (worse); more binding (higher number) indicates more binding (better), thus, measuring the overall health of the dopaminergic system in the brain. Analysis was completed only for the Oral and IV N acetyl Cysteine Cohort and Control Cohort; the Oral Supplements arm of the study was discontinued and not included in analysis

  Baseline and 90 ± 30 days

Other Outcomes (3)

• Years: Number of Years With Parkinson's

  Baseline to evaluate inclusion criteria

• Severity of Parkinson's Disease Symptom Progression Based Upon the Hoehn and Yahr Scale

  Baseline to evaluate inclusion criteria

• Whether Each Participant is Prescribed and Taking Carbidopa/Levodopa for Parkinson's Disease

  Baseline

Study Arms (3)

Oral and IV N acetyl Cysteine Cohort

EXPERIMENTAL

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

Control Cohort

ACTIVE COMPARATOR

Standard of Care Treatment

Other: Control group

Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin

ACTIVE COMPARATOR

Baicalin 400mg (Narula Reasearch) 2 x per day Curcumin Phytosome 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Frequency: over one hour 1 x per week for 90 days ± 30 days The protocol was amended; this cohort was not included in analysis that was reported in results.

Dietary Supplement: Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin

Interventions

Intravenous and Oral n-acetyl cysteine DIETARY_SUPPLEMENT

Oral and IV N acetyl Cysteine Cohort

Control group OTHER

Standard of Care

Control Cohort

Oral Supplements: Baicalin, Ganoderma, Omega 3 and Curcumin DIETARY_SUPPLEMENT

Baicalin 400mg (Narula Reasearch) 2 x per day Curcumin Phytosome 500mg (Thorne Research) 2 x per day Omega 3 Acids - ProEPA (Nordic Naturals) 1 x per day Ganoderma - Reishi Extract 500mg by Vital Nutrients (REIS8) 2 caps 2x per day Frequency: over one hour 1 x per week for 90 days ± 30 days

Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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.

  PMID: 27309537 BACKGROUND

• Monti DA, Zabrecky G, Kremens D, Liang TW, Wintering NA, Bazzan AJ, Zhong L, Bowens BK, Chervoneva I, Intenzo C, Newberg AB. N-Acetyl Cysteine Is Associated With Dopaminergic Improvement in Parkinson's Disease. Clin Pharmacol Ther. 2019 Oct;106(4):884-890. doi: 10.1002/cpt.1548. Epub 2019 Jul 17.

  PMID: 31206613 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases; Central Nervous System Diseases; Movement Disorders; Nervous System Diseases; Brain Diseases

Interventions

Acetylcysteine; Control Groups; Docosahexaenoic Acids; Curcumin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Synucleinopathies

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

The study was amended to discontinue the oral supplement group to focus on the Oral and IV Acetyl cysteine and the controls groups. Swallowing oral supplements was difficult. The randomization changed from 2:2:1 to a 1:1 ratio for enrollment in the remaining 2 groups. In error, the statistical analysis plan was not updated in the amended protocol.

Results Point of Contact

• Title: Andrew Newberg, M.D.
• Organization: Thomas Jefferson University

Andrew.Newberg@jefferson.edu

215-503-3423

Study Officials

• Daniel A Monti, MD,MBA

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an Open Label study. Randomization will occur via a 2:1 ratio of the NAC group and the control and oral supplement groups using the method of random permuted blocks with random block sizes without stratification. 28 subjects in the NAC arm, 14 subjects have been enrolled in the standard of care arm. 9 subjects who were enrolled in a discontinued oral supplement arm of the study were not included in final study analysis.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To evaluate whether IV/oral N acetyl cysteine, compared to standard of care ,no intervention, (or the discontinued oral supplementation arm) helps support dopamine function in the brains of patients with Parkinson's disease measured using Iofluvane (DATScan); clinical symptoms will be measured.

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: May 15, 2015
• Study Start: March 1, 2014
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Study scan report will be offer to the subject after subject completes study
• Access Criteria: Authorized research personnel

Locations

US (1)