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The Mito-Frail Trial: MitoQ for Frailty and Mild Cognitive Impairment

This study is testing if a supplement called MitoQ (Mitoquinone Mesylate) can help older adults who are experiencing frailty (physical weakness) and/or mild cognitive impairment (memory or thinking problems). Researchers want to see if MitoQ can improve how well your blood vessels work, your ability to move around, and your thinking skills. You might receive MitoQ or a placebo (an inactive capsule) for 12 weeks. The study is looking for 60 participants between 65 and 80 years old who have slow walking speed or mild cognitive impairment, and are otherwise in good heart health. The study's status is currently unclear, meaning it may not be actively recruiting yet.

Study design
This interventional study will enroll 60 participants. It compares the effects of MitoQ to a placebo capsule.
What's involved
You would take either MitoQ or a placebo capsule daily for 12 weeks. You will have four visits: at the beginning, after 12 weeks of treatment, after an 8-week break, and after another 12 weeks of treatment.
Compensation
Not stated in the trial record.
Follow-up
Your vascular function, cerebrovascular function, and cognitive performance will be measured at four visits over a period that includes an 8-week washout and a second 12-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06027554

The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults

Recruiting
PHASE2Ages 65–80InterventionalTreatment
UConn Health
~60 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:Mitoquinone MesylatePlacebo capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Vascular Endothelial Function
Measured over 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)
+4 more outcomes measured

Conditions

Frailty
Mild Cognitive Impairment
Aging

Explore related trials

FrailtyMild cognitive disorder

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Oh Sung Kwon, PhD · PRINCIPAL_INVESTIGATOR · University of Connecticut

Who to contact

Oh Sung Kwon, PhD
[email protected]
860-486-1120
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)

Exclusion

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)

What this trial measures

  • Change in Vascular Endothelial Function4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

    Assess Femoral artery through Passive Leg Movement and Brachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])

  • Change in Cerebrovascular Function4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

    Utilize ultrasound to measure a change in blood flow velocity in response to a breathing test (cm/s)

  • Change in NIH Tool Box Composite4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

    NIH Toolbox Cognitive Battery is a multidimensional set of brief measures assessing cognitive (as well as emotional, motor and sensory) function. There is no score range, but mean score is 100 with standard deviation 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.

  • Change in walking speed4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

    Gait speed calculated from 10 meter walk test. Only the 6 intermediate meters are recorded. Time is recorded by a manual chronometer. 3 records are done, mean time is calculated. Mean time is divided by 6 to obtain mean gait speed

  • Sensitivity of a Montreal Cognitive Assessment score4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

    sensitivity of a Montreal Cognitive Assessment score \< 26 to detect cognitive impairment defined as an abnormal result in at least one of the following tests : Test of Attentional Performance of Zimmermann and and Fimm (\< 5th percentile in at least one of the subscales) ; Wechsler Adult Intelligence Scale 4th version digit span (standard score ≤ 5) ; Wechsler memory scale III, spatial span (standard score ≤ 5) ; Wisconsin Card Scoring Test, GREFEX version (number of categories ≤ 5th percentile or if the number of perseverations is ≥ 95th percentile) Wechsler Adult Intelligence Scale 4th version block design (standard score ≤ 5) ; Six elements test GREFEX version (rank score ≤ 5th percentile ); free and cued selective reminding test, 16 items, B version (Z-score ≤ -1,65 in at least one of the subscales)