Measures of Mitochondria Dysfunction in PD

November 3, 2020 updated by: David Marcinek, University of Washington

Functional and Metabolomic Biomarkers of Mitochondrial Dysfunction in Parkinson's Disease

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.

Study Overview

Status

Unknown

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

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • University of Washington
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Parkinson's disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ATPmax
Time Frame: baseline
Maximal mitochondrial ATP production rates measured by magnetic resonance spectroscopy
baseline
NAD(H) metabolites
Time Frame: baseline
Measurement of relative NAD(H) metabolite concentrations in resting skeletal muscle by magnetic resonance spectroscopy
baseline
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.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitochondrial metabolites
Time Frame: baseline
Separate measurement of NAD(H) metabolite concentrations in cytosol and mitochondria by magnetic resonance spectroscopy in resting skeletal muscle
baseline
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.
baseline
Relationship between clinical assessment and mitochondrial energetics
Time Frame: baseline
Correlation between UPDRS with ATPmax and NAD(H) metabolites
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Marcinek, PhD, University of Washington
  • Principal Investigator: Laurie Mischley, ND, MPH, PhD, Bastyr University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

March 3, 2020

First Submitted That Met QC Criteria

March 5, 2020

First Posted (Actual)

March 9, 2020

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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