Parkinson Disease, MitochondrialNCT04300608
Measures of Mitochondria Dysfunction in PD
An observational study of Parkinson Disease, Mitochondrial, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Parkinson Disease, Mitochondrial
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Older adult
Study population: Patients diagnosed with Parkinson's disease
Who may be able to join
- 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.)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98109
Sophia Liu, PhD, 206-685-3533, sophia21@uw.edu
Eric Shankland, PhD, 206-685-3533, shanklan@uw.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease, Mitochondrial
- Keywords
- Parkinson Disease, Mitochondria, Skeletal Muscle, Bioenergetics
- Medical subject headings
- Parkinson Disease, Mitochondrial, Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
ATPmax
Maximal mitochondrial ATP production rates measured by magnetic resonance spectroscopy
Measured: baseline
NAD(H) metabolites
Measurement of relative NAD(H) metabolite concentrations in resting skeletal muscle by magnetic resonance spectroscopy
Measured: baseline
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.
Measured: baseline
Secondary outcomes (3)
Mitochondrial metabolites
Separate measurement of NAD(H) metabolite concentrations in cytosol and mitochondria by magnetic resonance spectroscopy in resting skeletal muscle
Measured: baseline
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.
Measured: baseline
Relationship between clinical assessment and mitochondrial energetics
Correlation between UPDRS with ATPmax and NAD(H) metabolites
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start24 Feb 2020
- Primary completionJul 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, MitochondrialStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, David Marcinek, University of Washington
- Investigators
- David Marcinek, PhD, Principal investigator, University of WashingtonLaurie Mischley, ND, MPH, PhD, Principal investigator, Bastyr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300608
- Sponsor's protocol ID
- STUDY00007024
- Status last verified
- Nov 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Metabolomic Biomarkers of Mitochondrial Dysfunction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04300608
- Acronym / sponsor ID
- STUDY00007024
- Conditions
- Parkinson Disease, Mitochondrial
- Keywords
- Parkinson Disease, Mitochondria, Skeletal Muscle, Bioenergetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients diagnosed with Parkinson's disease
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Mitochondrial metabolites
Time frame: baseline
Relationship between self report function and mitochondrial energetics
Time frame: baseline
Relationship between clinical assessment and mitochondrial energetics
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Marcinek, PhD principal investigator
University of Washington
Laurie Mischley, ND, MPH, PhD principal investigator
Bastyr University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, Mitochondrial, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophia Liu, PhD (206-685-3533, sophia21@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ATPmax (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.