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

Sponsor

Thomas Jefferson University (Other)

Overall Status

Completed

CT.gov ID

NCT02445651

Collaborator

(none)

Enrollment

Location

Arms

101.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Idiopathic Parkinson Disease	Dietary Supplement: Intravenous and Oral n-acetyl cysteine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

51 participants

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

Official Title:

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

Actual Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Aug 4, 2022

Actual Study Completion Date :

Aug 4, 2022

Arms and Interventions

Arm	Intervention/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
No Intervention: Control Cohort Standard of Care Treatment

Arm

Intervention/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

No Intervention: Control Cohort

Standard of Care Treatment

Outcome Measures

Primary Outcome Measures

Changes in the dopamine transporter (DAT) which reflects the overall health of the dopaminergic system [Baseline and 90 ± 30 days]
Single Photon Emission Computed Tomography (SPECT) Imaging (DaTScan) of Dopamine Uptake

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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