- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04300608
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
Conditions
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
- Name: Sophia Liu, PhD
- Phone Number: 206-685-3533
- Email: sophia21@uw.edu
Study Contact Backup
- Name: Laurie Mischley, ND, MPH, PhD
- Phone Number: (206) 525-8012
- Email: lauriemischley@mac.com
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Recruiting
- University of Washington
-
Contact:
- Sophia Liu, PhD
- Phone Number: 206-685-3533
- Email: sophia21@uw.edu
-
Contact:
- Eric Shankland, PhD
- Phone Number: 206-685-3533
- Email: shanklan@uw.edu
-
-
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00007024
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.
Clinical Trials on Parkinson Disease, Mitochondrial
-
Stealth BioTherapeutics Inc.TerminatedPrimary Mitochondrial DiseaseUnited States
-
Stealth BioTherapeutics Inc.CompletedPrimary Mitochondrial DiseaseUnited States
-
Children's Hospital of PhiladelphiaUniversity of Pennsylvania; United Mitochondrial Disease Foundation (UMDF)Recruiting
-
Minovia Therapeutics Ltd.Not yet recruiting
-
Stealth BioTherapeutics Inc.Active, not recruitingMitochondrial Diseases | Mitochondrial Myopathies | Mitochondrial Complex I Deficiency | Mitochondrial Pathology | Mitochondrial DNA Depletion | Mitochondrial DNA Mutation | Mitochondrial DNA Deletion | Mitochondrial Metabolism DefectSpain, United States, Italy, Netherlands, Australia, Germany, Hungary, New Zealand, Norway, United Kingdom
-
University Hospital, BordeauxRecruiting
-
Radboud University Medical CenterCompletedMitochondrial Disorders
-
Children's Hospital of PhiladelphiaUnited States Department of DefenseRecruitingMitochondrial Diseases | Mitochondrial MyopathiesUnited States
-
Newcastle-upon-Tyne Hospitals NHS TrustNewcastle UniversityCompleted
-
Rigshospitalet, DenmarkUniversity of CopenhagenRecruitingMitochondrial Diseases | Mitochondrial Myopathies | Mitochondrial DisorderDenmark