Measures of Mitochondria Dysfunction in PD

Parkinson Disease, Mitochondrial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300608
• Other study ID #: STUDY00007024
• Status: Recruiting
• Start date: February 24, 2020
• Est. completion date: November 2021

Study information

• Verified date: November 2020
• Source: University of Washington
• Contact: Sophia Liu, PhD
• Phone: 206-685-3533
• Email: sophia21[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2021
• Est. primary completion date: July 2021
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mitochondrial Diseases
• Parkinson Disease
• Parkinson Disease, Mitochondrial

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ATPmax	Maximal mitochondrial ATP production rates measured by magnetic resonance spectroscopy	baseline
Primary	NAD(H) metabolites	Measurement of relative NAD(H) metabolite concentrations in resting skeletal muscle by magnetic resonance spectroscopy	baseline
Primary	Muscle force and endurance	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	Mitochondrial metabolites	Separate measurement of NAD(H) metabolite concentrations in cytosol and mitochondria by magnetic resonance spectroscopy in resting skeletal muscle	baseline
Secondary	Relationship between self report function and mitochondrial energetics	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
Secondary	Relationship between clinical assessment and mitochondrial energetics	Correlation between UPDRS with ATPmax and NAD(H) metabolites	baseline