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

Parkinson Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease

• NCT number: NCT02445651
• Study type: Interventional
• Source: Thomas Jefferson University
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Completion date: August 4, 2022