The stated objective of this research career development award (K01) is to provide research training support for CAM practitioners with clinical doctorates, who have had limited opportunity for research training, but a strong desire to pursue a career in CAM research. Having seven years of clinical expertise in the field of CAM neurology as a Naturopathic Doctor (ND) and consistent clinical research involvement throughout the duration of my career, I am an ideal candidate for this training opportunity. This Career Development Award will provide an opportunity for me to transition to a research career, capitalizing on the clinical expertise I have developed thus far. It is my long-term objective to become a competent, efficient and productive principal investigator and collaborator on research topics specific to CAM treatments of neurological disorders.
My specific aims are: 1) to complete didactic coursework at the University of Washington relevant to my training as a clinical researcher, specifically, the MPH in Epidemiology;2) conduct a double-blind placebo- controlled trial with a popular CAM therapy using a novel delivery method, intranasal glutathione, in Parkinson's Disease;3) acquire appropriate ethics training;and, 4) obtain mentorship from two highly qualified, interdisciplinary researchers;Dr. Standish, an experienced CAM researcher at Bastyr University, and Dr. Samii, an experienced neurology/Parkinson's disease researcher at the University of Washington and Veteran's Administration of Puget Sound. Parkinson's disease, the second most common neurodegenerative disease in the United States, is currently considered irreversible and progressive. While symptomatic therapies are available, there are currently no therapies capable of slowing the disease course. It is well established that brain levels of glutathione are decreased in Parkinson's disease, and that the reduction in this brain antioxidant may contribute to disease progression. Glutathione is being used by CAM providers around the world to treat Parkinson's disease, as a purported method of slowing disease progression, but no rigorous scientific studies have been conducted to evaluate its safety, tolerability or efficacy. The proposed research study, """"""""Intranasal Glutathione in Parkinson's Disease"""""""", is a Phase I double-blind, placebo-controlled, dose escalation study designed to evaluate the safety, tolerability and absorption of glutathione in Parkinson's disease.

Public Health Relevance

Parkinson's disease (PD) is the second most common neurodegenerative disorder in the U.S. Prevalence and incidence rates increase with age. Owing to the aging of most populations worldwide, the prevalence of PD and other neurological disorders is projected to rise in the future, and the financial burden is likely to rise accordingly. A recent study estimated the direct cost of Parkinson's disease to be $US 26 billion annually, mostly associated with prescription medicines and nursing home care. Finding innovative treatments that halt disease progression are of paramount importance to public health.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Scientist Development Award - Research & Training (K01)
Project #
5K01AT004404-02
Application #
8011367
Study Section
Special Emphasis Panel (ZAT1-LD (32))
Program Officer
Sorkin, Barbara C
Project Start
2010-01-01
Project End
2014-12-31
Budget Start
2011-01-01
Budget End
2011-12-31
Support Year
2
Fiscal Year
2011
Total Cost
$120,194
Indirect Cost
Name
Bastyr University
Department
Type
Organized Research Units
DUNS #
055652309
City
Kenmore
State
WA
Country
United States
Zip Code
98028
Mischley, Laurie K; Lau, Richard C; Bennett, Rachel D (2017) Role of Diet and Nutritional Supplements in Parkinson's Disease Progression. Oxid Med Cell Longev 2017:6405278
Mischley, Laurie K; Leverenz, James B; Lau, Richard C et al. (2015) A randomized, double-blind phase I/IIa study of intranasal glutathione in Parkinson's disease. Mov Disord 30:1696-701
Mischley, Laurie K; Vespignani, Marco F; Finnell, John S (2013) Safety survey of intranasal glutathione. J Altern Complement Med 19:459-63
Mischley, Laurie K; Allen, Jason; Bradley, Ryan (2012) Coenzyme Q10 deficiency in patients with Parkinson's disease. J Neurol Sci 318:72-5