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

NCT06027554 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 23-132S-11K01AG080164-01AG220138
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change in Vascular Endothelial Function

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

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

• Change in Cerebrovascular Function

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

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

• Change in NIH Tool Box Composite

  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.

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

• Change in walking speed

  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

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

• Sensitivity of a Montreal Cognitive Assessment score

  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)

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

Secondary Outcomes (2)

• Change in Mitochondrial Function measured in peripheral blood mononuclear cells (PBMCs)

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

• Change in Oxidative Stress measured in peripheral blood mononuclear cells (PBMCs) by O2flux in pmol/second/cell numbers

  4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)

Study Arms (2)

Placebo capsule

PLACEBO COMPARATOR

Gelatin capsules

Dietary Supplement: Placebo capsule

MitoQ capsule

EXPERIMENTAL

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

Drug: Mitoquinone Mesylate

Interventions

Mitoquinone Mesylate DRUG

MitoQ given 20 mg per day for 12 weeks.

MitoQ capsule

Placebo capsule DIETARY_SUPPLEMENT

Placebo capsule taken every day for 12 weeks.

Placebo capsule

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify 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 may not qualify 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
• 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)

Sponsors & Collaborators

• UConn Health: lead
• National Institute on Aging (NIA): collaborator
• University of Connecticut: collaborator

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

RECRUITING

MeSH Terms

Conditions

Frailty; Cognitive Dysfunction

Interventions

mitoquinone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Oh Sung Kwon, PhD

  University of Connecticut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oh Sung Kwon, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 7, 2023
• Study Start: October 7, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 9, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)