Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT02445651
Status:
COMPLETED
Last Update Posted:
2025-12-15
First Post:
2015-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Physiological Effects of Nutritional Support in Patients With Parkinson's Disease
Status:
COMPLETED
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
The first arm of this study received 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. NAC 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 was a waitlist control group who received no intervention. The control group continued to receive clinical standard of care treatment for PD care provided by their neurologist.
A third arm of the study was an oral supplement group who received Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin.This oral supplement group continued to receive clinical standard of care treatment for PD provided by their neurologist.
The protocol was amended to include only the NAC arm and the standard of care waitlist control groups.
The second arm was a waitlist control group who received no intervention. The control group continued to receive clinical standard of care treatment for PD care provided by their neurologist.
A third arm of the study was an oral supplement group who received Oral Supplements Cohort Baicalin, Ganoderma, Omega 3 and Curcumin.This oral supplement group continued to receive clinical standard of care treatment for PD provided by their neurologist.
The protocol was amended to include only the NAC arm and the standard of care waitlist control groups.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: