Recruiting
Phase 2

MitoQ

Sponsor:

UConn Health

Code:

NCT06027554

Conditions

Frailty

Mild Cognitive Impairment

Aging

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Mitoquinone Mesylate

Placebo capsule

Study Details

Brief summary:

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.

Conditions

Frailty

Mild Cognitive Impairment

Aging

Study ID

NCT06027554

Start date

Oct 7, 2024

Status verified date

Aug, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo capsule

Gelatin capsules

experimental: MitoQ capsule

Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 20 mg taken every day for 12 weeks.

Interventions

Mitoquinone Mesylate

MitoQ given 20 mg per day for 12 weeks.

Placebo capsule

Placebo capsule taken every day for 12 weeks.

Primary outcome measure

  • Change in Vascular Endothelial Function [ Time Frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo) ]
  • Change in Cerebrovascular Function [ Time Frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo) ]
  • Change in NIH Tool Box Composite [ Time Frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo) ]
  • Change in walking speed [ Time Frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo) ]
  • Sensitivity of a Montreal Cognitive Assessment score [ Time Frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo) ]

Central Contacts and Locations

Central contacts

Oh Sung Kwon, PhD

860-486-1120ohsung.kwon@uconn.edu

Locations

UConn Health

Recruiting

Farmington, Connecticut, United States, 06030

Contacts

George Kuchel, MD

860-679-6796kuchel@uchc.edu

More Information

Sponsor

UConn Health

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UConn Health on 2026-08-12.