Clinical trial NCT02445651: 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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Changes in the dopamine transporter (DAT) which reflects the overall health of the dopaminergic system
timeFrame: Baseline and 90 ± 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Daniel A Monti, MD,MBA
role: PRINCIPAL_INVESTIGATOR
References:
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.