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



Status:Active, not recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 80
Updated:5/24/2018
Start Date:March 2014
End Date:December 6, 2018

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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.

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.

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
We found this trial at
1
site
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Daniel A Monti, MD
Phone: 215-503-3423
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Philadelphia, PA
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