Measures of Mitochondria Dysfunction in PD

NCT ID: NCT04300608

Last Updated: 2020-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-24

Study Completion Date

2021-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease, Mitochondrial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

David Marcinek

Professor of Radiology Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Marcinek, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Laurie Mischley, ND, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Bastyr University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sophia Liu, PhD

Role: CONTACT

206-685-3533

Laurie Mischley, ND, MPH, PhD

Role: CONTACT

(206) 525-8012

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sophia Liu, PhD

Role: primary

206-685-3533

Eric Shankland, PhD

Role: backup

206-685-3533

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY00007024

Identifier Type: -

Identifier Source: org_study_id