Clinical trial NCT04300608: Measures of Mitochondria Dysfunction in PD
Official title: Functional and Metabolomic Biomarkers of Mitochondrial Dysfunction in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease, Mitochondrial
Keywords: Parkinson Disease
Mitochondria
Skeletal Muscle
Bioenergetics
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2020-03-09
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with 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.

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.

Primary outcomes:
measure: ATPmax
timeFrame: baseline
measure: NAD(H) metabolites
timeFrame: baseline
measure: Muscle force and endurance
timeFrame: baseline
Secondary outcomes:
measure: Mitochondrial metabolites
timeFrame: baseline
measure: Relationship between self report function and mitochondrial energetics
timeFrame: baseline
measure: Relationship between clinical assessment and mitochondrial energetics
timeFrame: baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: David Marcinek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bastyr University
name: Laurie Mischley, ND, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: