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Intranasal Glutathione in Parkinson's Disease

Award Number: K01AT004404
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 01/01/2010
PERIOD OF PERFORMANCE END DATE: 12/31/2014

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Intranasal Glutathione in Parkinson's Disease - DESCRIPTION (provided by applicant): 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2014 ( Subtotal = $118,995 )
2014	2014	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	003	5	5/20/2014	NON-COMPETING CONTINUATION	$0
2014	2014	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	5	3/14/2014	NON-COMPETING CONTINUATION	$9,094
2014	2014	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	5	1/10/2014	NON-COMPETING CONTINUATION	$106,332
2014	2014	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	002	5	3/17/2014	NON-COMPETING CONTINUATION	$3,569
														Subtotal = $118,995

Issue Date FY: 2013 ( Subtotal = $115,211 )
2013	2013	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	4	3/1/2013	NON-COMPETING CONTINUATION	$0
2013	2013	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	4	12/31/2012	NON-COMPETING CONTINUATION	$106,896
2013	2013	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	002	4	5/24/2013	NON-COMPETING CONTINUATION	$8,315
														Subtotal = $115,211

Issue Date FY: 2012 ( Subtotal = $118,159 )
2012	2012	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	002	3	9/17/2012	NON-COMPETING CONTINUATION	$0
2012	2012	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	3	8/29/2012	NON-COMPETING CONTINUATION	$0
2012	2012	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	3	7/2/2012	NON-COMPETING CONTINUATION	$118,159
														Subtotal = $118,159

Issue Date FY: 2011 ( Subtotal = $120,194 )
2011	2011	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	2	1/27/2011	NON-COMPETING CONTINUATION	$120,194
														Subtotal = $120,194

Issue Date FY: 2010 ( Subtotal = $116,820 )
2010	2010	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	000	1	12/31/2009	NEW	$116,820
2010	2010	BASTYR UNIVERSITY	14500 JUANITA DRIVE NE	BOTHELL	WA	98011	KING	USA	Research and Training in Complementary and Integrative Health	001	1	8/9/2010	NEW	$0
														Subtotal = $116,820

Grand Total All Awards = $589,379

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Intranasal Glutathione in Parkinson's Disease

Award Number: K01AT004404

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 01/01/2010

PERIOD OF PERFORMANCE END DATE: 12/31/2014

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