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Measures of Mitochondria Dysfunction in PD

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ClinicalTrials.gov Identifier: NCT04300608
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : November 5, 2020
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
David Marcinek, University of Washington

Brief Summary:
This study evaluates metabolic and functional parameters in the skeletal muscle of Parkinson's disease patients for comparison to a set of healthy age-matched controls.

Condition or disease
Parkinson Disease, Mitochondrial

Detailed Description:
The goal of this study is to identify the unique signature of bioenergetic markers and mitochondrial (dys)function in muscle of individuals with PD, who are 65-85 of age, read and speak English, have a Hoehn & Yahr score between 2 and 3 (bilateral disease, not severely disabled) and have a clinical diagnosis of PD. Bioenergetic markers and muscle functional properties will be compared to a control dataset collected over the last few years from healthy elderly subjects in the same age range to provide a foundation for future intervention studies.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Functional and Metabolomic Biomarkers of Mitochondrial Dysfunction in Parkinson's Disease
Actual Study Start Date : February 24, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : November 2021





Primary Outcome Measures :
  1. ATPmax [ Time Frame: baseline ]
    Maximal mitochondrial ATP production rates measured by magnetic resonance spectroscopy

  2. NAD(H) metabolites [ Time Frame: baseline ]
    Measurement of relative NAD(H) metabolite concentrations in resting skeletal muscle by magnetic resonance spectroscopy

  3. Muscle force and endurance [ Time Frame: baseline ]
    Maximum voluntary contraction (MVC) force in Newtons and fatigue resistance assessed by the ability to maintain repeated contractions at 70% MVC will be measured in the hand (flexor digitorum interroseus) and leg (tibialis anterior) using isometric contractions in a custom made apparatus.


Secondary Outcome Measures :
  1. Mitochondrial metabolites [ Time Frame: baseline ]
    Separate measurement of NAD(H) metabolite concentrations in cytosol and mitochondria by magnetic resonance spectroscopy in resting skeletal muscle

  2. Relationship between self report function and mitochondrial energetics [ Time Frame: baseline ]
    Correlation between self report of fatigue, balance, and muscle pain (PRO-PD) with ATPmax rates and NAD(H) metabolite concentrations measured using magnetic resonance spectroscopy.

  3. Relationship between clinical assessment and mitochondrial energetics [ Time Frame: baseline ]
    Correlation between UPDRS with ATPmax and NAD(H) metabolites



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with Parkinson's disease
Criteria

Inclusion Criteria:

  • Age 65-85 years.
  • Ability to attend a 3-hour study visit in Seattle, WA.
  • Ability to read and speak English.
  • Hoehn & Yahr Stage 2-3. (bilateral disease, not severely disabled.)

Exclusion Criteria:

  • Any contra-indication to magnetic resonance imaging
  • A history of epilepsy, stroke, brain surgery, or structural brain disease.
  • The presence of other serious illnesses
  • Current or recent enrollment in a clinical trial involving an investigational product or device.
  • Supplementation with NAD, nicotinamide mononucleotide (NMN), nicotinamide riboside (NR), and other nutraceuticals designed to target NAD for 30 days prior to baseline study visit.
  • 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.
  • Right limb tremor or dyskinesia that cannot be comfortably controlled for 90 minutes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300608


Contacts
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Contact: Sophia Liu, PhD 206-685-3533 sophia21@uw.edu
Contact: Laurie Mischley, ND, MPH, PhD (206) 525-8012 lauriemischley@mac.com

Locations
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United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98109
Contact: Sophia Liu, PhD    206-685-3533    sophia21@uw.edu   
Contact: Eric Shankland, PhD    206-685-3533    shanklan@uw.edu   
Sponsors and Collaborators
University of Washington
Michael J. Fox Foundation for Parkinson's Research
Investigators
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Principal Investigator: David Marcinek, PhD University of Washington
Principal Investigator: Laurie Mischley, ND, MPH, PhD Bastyr University
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Responsible Party: David Marcinek, Professor of Radiology Research, University of Washington
ClinicalTrials.gov Identifier: NCT04300608    
Other Study ID Numbers: STUDY00007024
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: November 5, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Marcinek, University of Washington:
Parkinson Disease
Mitochondria
Skeletal Muscle
Bioenergetics
Additional relevant MeSH terms:
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Parkinson Disease
Mitochondrial Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Metabolic Diseases