A Phase 2 interventional study of Mitoquinone Mesylate and Placebo capsule in Frailty, Mild Cognitive Impairment and Aging, sponsored by UConn Health. Recruiting at 1 site in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by UConn Health · Phase 2, Interventional, and Treatment
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:
Chronic diseases and associated declines in physical and cognitive performance contribute greatly to lost independence with aging. In addition to a lack of effective interventions other than exercise to address either problem, few studies have examined strategies for targeting both conditions in frail individuals who may experience difficulties with both walking and memory. Use of geroscience-guided therapies permits us to target mechanisms shared by aging with chronic conditions for which aging represents a major risk factor. Thus, instead of focusing on one single disease at a time, it may be possible to delay the onset and progression of disability involving multiple functional domains.
Gait speed is predictive of mobility, morbidity, and mortality in older adults. Vasoreactivity is a critical cerebrovascular control mechanism used to maintain brain perfusion during metabolic demands such as walking. In contrast to healthy older adults, middle cerebral artery blood flow velocities fail to increase proportionally in response to walking speed in slow walkers. Thus, abnormalities in vasoreactivity and perfusion adaptation to metabolic demands may reflect and contribute to declines in gait speed.
Mild cognitive impairment (MCI), an intermediate condition between normal cognitive performance and dementia, significantly increases the risk of transitioning dementia caused by Alzheimer's disease (AD). Moreover, changes in physical and cognitive function frequently co-exist in the same individual and influence each other.
In the absence of other effective therapies, modifiable cardiovascular risk factors (e.g., hypertension, atherosclerosis, cerebral hypoperfusion) represent opportunities to prevent declines in physical and cognitive function by targeting the vascular endothelium and vasodilation.
Physiological reactive oxygen species (ROS) levels play critical roles in cerebral vasculature, which can contribute to the regulation of brain perfusion through their action in vascular tone control. Of the many potential cellular sources of ROS in the vasculature, mitochondria are the major source in endothelium regulation of vascular homeostasis and are associated with aging and cardiovascular disease. Specifically, mitochondrialtargeted antioxidant, MitoQ, improves vascular endothelial function by reducing mitochondrial ROS (mtROS) in older adults and animal models.
Investigators have recently shown that MitoQ, a mitochondria-targeted antioxidant known to improve endothelial function and Nitric Oxide (NO) bioavailability, also restore impaired flow-mediated vasodilation in frail older adults, enhancing gait speed. In the Mito-Frail study, investigators will explore the hypothesis that MitoQ attenuates aging-related declines in flow-mediated vasodilation involving both peripheral and cerebral blood vessels. At the same time, investigators will obtain feasibility and pilot data involving measures of physical mobility and cognitive performance that may help us design and power a future clinical trial. Thus, this study will seek to develop strategies for preventing or slowing the progression of Alzheimer's Disease and the vascular contribution to dementia.
Therefore, Aim 1 will assess peripheral and cerebral NO bioavailability and mitochondrial reactive oxygen species (mtROS) levels in older adults who are healthy, others who are frail with slow walking speed and those who meet criteria for mild cognitive impairment (MCI). Aim 2 will determine whether MitoQ supplementation can enhance NO bioavailability and improve declines in flow-mediated vasodilation central and cerebral vessels.
Moreover, this study will also generate physical performance and cognitive data needed to design and power a future clinical trial focused on these functional outcomes.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 60 is below the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Gelatin capsules
Dietary Supplement: Placebo capsule
Capsules containing mitoquinone mesylate (MitoQ, 5 mg/capsule) totaling 20 mg taken every day for 12 weeks.
Drug: Mitoquinone Mesylate
MitoQ given 20 mg per day for 12 weeks.
Placebo capsule taken every day for 12 weeks.
Change in Vascular Endothelial Function
Assess Femoral artery through Passive Leg Movement and Brachial artery flow-mediated dilation (% \[relative\] and mm \[absolute\])
Time frame: 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)
Time frame: 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.
Time frame: 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
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
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)
Time frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)
Change in Mitochondrial Function measured in peripheral blood mononuclear cells (PBMCs)
Measure mitochondrial respiratory function using peripheral blood mononuclear cells (PBMCs) using oroboros O2k system expressed by O2flux in pmol/second/cell numbers
Time frame: 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
Measure Mitochondrial-derived reactive oxygen species (ROS) using peripheral blood mononuclear cells (PBMCs) using oroboros O2k system expressed by Amplex flux in pmol/second/cell numbers
Time frame: 4 visits : Baseline, 12 weeks (MitoQ or Placebo), 8 weeks washout, 12 weeks (MitoQ or Placebo)
Plan to share: No
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Studies of the drug tested here: Mitoquinone