Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2014-12-31
2015-03-31
Brief Summary
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Detailed Description
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Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione levels.
Hypothesis: Mean MRS glutathione concentration will rise from baseline following administration of 1 cc 200 mg/ml (in)GSH.
Design and Outcomes:
This pilot study seeks to obtain baseline data regarding the feasibility of MRS to detect a change in CNS glutathione concentration following administration of 200 mg (in)GSH. CNS glutathione levels will be measured using magnetic resonance spectroscopy (MRS), with the putamen as the region of interest. Baseline brain GSH concentrations will be measured by MRS at approximately the same time each day in all individuals before and after administration of study medication.
Outcome Measure: Describe the change in mean GSH concentration following administration of (in)GSH. The data analysis will be ipsative- results will be reported as percent change from the individual's own baseline GSH concentration.
Interventions and Duration:
If a participant communicates he/she understands the study, meets inclusion criteria, and provides informed consent, individuals will be scheduled for a single visit at the University of Washington for MR imaging (MRI), clinical evaluation, and blood draw. (\~ 3 hours). Participants will be asked to be optimally medicated at the time of study visit, to the best of their ability.
Sample Size and Population:
This is a proof-of-concept pilot trial. Based on the data from the single test subject, a sample size of 15 would provide 80% power to detect an increase in CNS glutathione concentrations between pre- and post- administration values, if we are willing to accept an alpha value of 0.2.
1.1 Primary Aims
Primary Aim: To determine whether intranasal reduced glutathione, (in)GSH, is capable of augmenting CNS glutathione concentration. (Region of Interest: putamen)
Hypothesis: Mean MRS glutathione concentration will rise from baseline approximately 15 minutes following administration of 200 mg/ml (in)GSH in 1 cc saline.
1.2 Secondary Objectives
Hypothesis: Baseline CNS glutathione concentrations and RBC glutathione concentrations will be correlated.
1\. To determine whether brain MRS \[glutathione\] and red blood cell (RBC) glutathione levels are correlated.
Outcome: A ROC curve will be drawn between mean brain \[glutathione\] and RBC total glutathione.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Reduced Glutathione
The study medication is packaged in sterile 1 ml pre-filled syringes, each containing 200 mg/ ml of reduced glutathione (GSH), which will be delivered intranasally.
Reduced Glutathione
200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Interventions
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Reduced Glutathione
200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to attend a 3 hour study visit in Seattle, WA.
* Ability to read and speak English.
* Have three or more of the required positive criteria for PD from Step 3 of the UK Brain Bank Diagnostic Criteria for Parkinson's Disease.
* A modified Hoehn \& Yahr Stage 2-3. (bilateral disease, not severely disabled.)
Exclusion Criteria
* A history of epilepsy, stroke, brain surgery, or structural brain disease.
* The presence of other serious illnesses (discretion of study clinician, e.g. concurrent cancer treatment.)
* Pregnant.
* A history of sulfur sensitivity, e.g. reaction N-acetylcysteine, MSM, SAMe.
* A recent history of asthma.
* Supplementation with glutathione (oral, intravenous, intranasal, or nebulized) or the glutathione precursor, N-acetylcysteine, for six months prior to baseline study visit.
* History of sensitivity to sulfur containing medications/ supplements, i.e. NAC, MSM.
* Current drug or alcohol use or dependence.
* Inability/unwillingness to provide informed consent. (e.g. diagnosis of dementia, confusion about study goals or participation.)
* Acute infection (e.g. upper respiratory, dermal) in the previous 30 days.
* Diagnosis of any mental illness, ever. (Mental illness has been associated with glutathione depletion.)
* Diagnosis of any chronic disease, ever. (e.g. Hep C, autoimmune disease, etc.)
* Head tremor or head dyskinesia that cannot be comfortably controlled for 90 minutes.
18 Years
ALL
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
University of Washington
OTHER
Responsible Party
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Laurie Mischley
Project Appointment
Principal Investigators
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Kevin Conley, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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University of Washington
Seattle, Washington, United States
Countries
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References
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Cacciatore I, Baldassarre L, Fornasari E, Mollica A, Pinnen F. Recent advances in the treatment of neurodegenerative diseases based on GSH delivery systems. Oxid Med Cell Longev. 2012;2012:240146. doi: 10.1155/2012/240146. Epub 2012 Jun 3.
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Mischley LK SL, Samii A, Pollisar N, Lau R, Leverenz J, . Phase I Study of Intranasal Glutathione in Parkinson's Disease. Seattle: Bastyr University Research Instittue; 2013.
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DelleDonne A, Klos KJ, Fujishiro H, Ahmed Z, Parisi JE, Josephs KA, Frigerio R, Burnett M, Wszolek ZK, Uitti RJ, Ahlskog JE, Dickson DW. Incidental Lewy body disease and preclinical Parkinson disease. Arch Neurol. 2008 Aug;65(8):1074-80. doi: 10.1001/archneur.65.8.1074.
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Emir UE, Raatz S, McPherson S, Hodges JS, Torkelson C, Tawfik P, White T, Terpstra M. Noninvasive quantification of ascorbate and glutathione concentration in the elderly human brain. NMR Biomed. 2011 Aug;24(7):888-94. doi: 10.1002/nbm.1646. Epub 2011 Jan 12.
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Other Identifiers
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48273-A
Identifier Type: -
Identifier Source: org_study_id