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New treatment option for Frailty
Official title The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
ClinicalTrials.gov ID: NCT06027554
What this study is testing
What is Mitoquinone Mesylate?
Mitoquinone Mesylate is an investigational medicine, being studied as a potential treatment for frailty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to test the effects of MitoQ supplementation in older adults and frail older adults with physical dysfunction and/or cognitive dysfunction. The main question(s) it aims to answer are: To compare vascular function, oxidative stress levels, and physical and cognitive function among older adults and frail older adults with physical and cognitive dysfunction To determine whether MitoQ supplementation has the potential to improve vascular function in central and cerebral vessels To determine whether MitoQ supplementation can enhance physical and cognitive capabilities.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 80. Healthy volunteers may be eligible.
You may be able to join if
- men and women aged 65-80 with a slow gait speed (0.4m/s based on a 4m walk) and/or mild cognitive impairment.
- good cardiovascular health (not taking any blood pressure/flow/metabolism altering medications)
You likely can't join if
- A vaccination in past two weeks
- Recent acute infection three weeks prior to enrollment
- Known immunodeficiency (including HIV infection, primary immunodeficiency, any history of chemotherapy or radiotherapy
- Use of medicines during past 6 months known to alter immune response such as high- dose corticosteroids
- Severe autoimmune disease requiring biological therapy
- Major severe illness and/or Hospitalization in past 3 months
See the full eligibility criteria
- men and women aged 65-80 with a slow gait speed (0.4m/s based on a 4m walk) and/or mild cognitive impairment.
- good cardiovascular health (not taking any blood pressure/flow/metabolism altering medications)
- A vaccination in past two weeks
- Recent acute infection three weeks prior to enrollment
- Known immunodeficiency (including HIV infection, primary immunodeficiency, any history of chemotherapy or radiotherapy
- Use of medicines during past 6 months known to alter immune response such as high- dose corticosteroids
- Severe autoimmune disease requiring biological therapy
- Major severe illness and/or Hospitalization in past 3 months
- On warfarin or other medications that are considered a blood thinner
- Recent fall or other conditions that will impair ability to complete and/or interpret mobility performance test
- Known bleeding disorder
- Any conditions that would impair the function to perform grip strength test
- include advanced neurological disease, severe co-morbid disease, terminal illness with reduced life expectancy, severe disability, unintentional weight loss in last 12 months and participation in another study.
- Diabetes patients requiring insulin (For reducing the risk that participants will have hypoglycemic episodes when fasting for study visits)
- Baseline ECG QTc \>450 ms in men and QTc \>460 ms in women
- Prior diagnosis of ventricular arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes)
The study team makes the final eligibility decision.
Where it's taking place
- Farmington, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Farmington, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.