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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

Tracking Information
First Submitted Date March 3, 2020
First Posted Date March 9, 2020
Last Update Posted Date November 5, 2020
Actual Study Start Date February 24, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2020)
  • ATPmax [ Time Frame: baseline ]
    Maximal mitochondrial ATP production rates measured by magnetic resonance spectroscopy
  • NAD(H) metabolites [ Time Frame: baseline ]
    Measurement of relative NAD(H) metabolite concentrations in resting skeletal muscle by magnetic resonance spectroscopy
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 5, 2020)
  • Mitochondrial metabolites [ Time Frame: baseline ]
    Separate measurement of NAD(H) metabolite concentrations in cytosol and mitochondria by magnetic resonance spectroscopy in resting skeletal muscle
  • 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.
  • Relationship between clinical assessment and mitochondrial energetics [ Time Frame: baseline ]
    Correlation between UPDRS with ATPmax and NAD(H) metabolites
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measures of Mitochondria Dysfunction in PD
Official Title Functional and Metabolomic Biomarkers of Mitochondrial Dysfunction in Parkinson's Disease
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients diagnosed with Parkinson's disease
Condition Parkinson Disease, Mitochondrial
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2020)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sophia Liu, PhD 206-685-3533 sophia21@uw.edu
Contact: Laurie Mischley, ND, MPH, PhD (206) 525-8012 lauriemischley@mac.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04300608
Other Study ID Numbers STUDY00007024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party David Marcinek, University of Washington
Study Sponsor University of Washington
Collaborators Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: David Marcinek, PhD University of Washington
Principal Investigator: Laurie Mischley, ND, MPH, PhD Bastyr University
PRS Account University of Washington
Verification Date November 2020