MitoTempol for Cognitive Impairment

Overseen By Jody Greaney, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Must not be taking: Cardiovascular drugs, Psychoactive drugs

Disqualifiers: Cognitive impairment, Cardiovascular diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily stress affects heart health and brain function in middle-aged adults and whether this stress could lead to future cognitive issues. The researchers will test MitoTempol, an experimental treatment, to determine its effectiveness against these stress-related effects. Participants will track their stress levels daily for two weeks and undergo assessments of heart and blood vessel health. Ideal candidates are middle-aged individuals who consider themselves generally healthy or have major depressive disorder but do not have diagnosed cognitive or major health issues. As an unphased trial, this study offers a unique opportunity to contribute to understanding stress impacts and potential treatments.

Will I have to stop taking my current medications?

If you are currently using medications that affect heart function or any psychoactive drugs, you will need to stop taking them at least 8 weeks before joining the trial.

What prior data suggests that MitoTempol is safe for middle-aged adults?

Research has shown that MitoTempol has been studied for its effects on mitochondrial health. Mitochondria are tiny cell components that help produce energy. Some studies suggest that improving mitochondrial function might aid conditions like depression. However, information on MitoTempol's safety for humans remains limited.

As a pilot trial, this research is in its early stages. Early trials are typically small and focus on understanding safety and effects, so extensive safety information may not yet be available.

Participants should always ask the trial team for detailed information about any reported side effects or issues. They should feel comfortable discussing any concerns with the researchers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for cognitive impairment, which often focus on neurotransmitters, MitoTempol targets oxidative stress in the brain. This novel approach involves using MitoTempol, an antioxidant compound, to protect brain cells from damage, potentially improving cognitive function. Researchers are excited because this could offer a new pathway to treat cognitive issues, especially for those with major depressive disorder, potentially leading to improved outcomes beyond what current therapies can achieve.

What evidence suggests that MitoTempol might be an effective treatment for cognitive impairment?

Research has shown that MitoTempol, a special antioxidant targeting energy centers in cells, might improve brain function. Studies have found that it protects brain cells and reduces damage linked to memory and thinking problems. In mice, MitoTempol improved brain issues caused by low blood sugar and reduced damage to brain blood vessels. This suggests it might help in conditions where the brain is under stress or damaged. While most evidence comes from animal studies, these findings are promising for future use in humans. This trial studies MitoTempol in two groups: middle-aged healthy adults and middle-aged adults with major depressive disorder, to evaluate its potential benefits on cognitive impairment. ^{6 7 8 9 10}

Who Is on the Research Team?

Jody Greaney, PhD

Principal Investigator

University of Delaware

Are You a Good Fit for This Trial?

This trial is for middle-aged adults who may be experiencing cognitive impairment. To join, participants must be able to complete online surveys and attend two lab visits about six months apart. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am between 40 and 55 years old.

Absence of objective cognitive impairment (≥26 on the Montreal Cognitive Assessment)

Participants must have a level of understanding of the English language sufficient to provide informed consent and to agree to all tests and procedures, as well as the capacity and willingness to attend all study related visits and to comply with the study protocol

Exclusion Criteria

Body mass index ≥35 kg/m2

I am not allergic to any medications used in this study.

Resting systolic BP ≥140 mmHg

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Ambulatory Assessment

Participants complete daily assessments of stress and cognitive function using a mobile app for 14 consecutive days

14 days

Daily assessments (virtual)

Laboratory Assessment

Vascular function is assessed using intradermal microdialysis and laser Doppler flowmetry

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the assessment cycles

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MitoTempol

Trial Overview The study tests the effects of daily stress on heart health and brain function using MitoTempol. It involves two 15-day testing cycles with daily online assessments and a final lab visit for vascular function checks.

How Is the Trial Designed?

Group I: middle-aged adults with major depressive disorder Experimental Treatment 2 Interventions

middle-aged adults with major depressive disorder

Group II: middle-aged healthy adults Active Control 2 Interventions

middle-aged healthy adults

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+

National Institute of General Medical Sciences (NIGMS)

Collaborator

Trials

315

Recruited

251,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8125007/

Mitochondrial Dysfunction as a Driver of Cognitive Impairment ... A growing body of evidence implicates mitochondrial dysfunction as a common pathomechanism involved in many of the hallmark features of the AD brain.

2. researchgate.net researchgate.net/publication/361829874_Mito-TEMPO_a_mitochondria-targeted_antioxidant_improves_cognitive_dysfunction_due_to_hypoglycemia_An_association_with_reduced_pericyte_loss_and_blood-brain_barrier_leakage/fulltext/64ff342625ee6b7564e11eb2/Mito-TEMPO-a-mitochondria-targeted-antioxidant-improves-cognitive-dysfunction-due-to-hypoglycemia-An-association-with-reduced-pericyte-loss-and-blood-brain-barrier-leakage.pdf?origin=scientificContributions

Mito-TEMPO, a mitochondria-targeted antioxidant, ... In this study, we constructed a T1D mouse model of severe hypoglycemia to observe the effects of severe hypoglycemia on cognitive function in ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0891584924004465

MitoTempo protects against nε-carboxymethyl lysine- ... More important, the protective effect of MitoTempo against neuronal dysfunction and cognitive declined has been widely investigated [[18], [19], ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36357613/

Mito-TEMPO, a Mitochondria-Targeted Antioxidant ... Mito-TEMPO, a Mitochondria-Targeted Antioxidant, Improves Cognitive Dysfunction due to Hypoglycemia: an Association with Reduced Pericyte Loss ...

5. cell.com cell.com/iscience/fulltext/S2589-0042(23)02766-9

High glucose impairs cognitive function through inducing ... High glucose induces cognitive impairment by promoting Treg dysfunction. High glucose downregulates NCLX and leads to mitochondrial calcium overload in Treg.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10971738/

Mitochondrial Metabolism in Major Depressive Disorder The aim of this review is examining the link between mitochondrial dysfunction and MDD, assessing how mitochondrial biomarkers could provide a more objective ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332223014506

Mitochondrial dysfunction: A fatal blow in depression This review summarizes the influence of mitochondrial dysfunction and the underlying molecular pathways on the pathogenesis of depression.

8. eneuro.org eneuro.org/content/eneuro/12/9/ENEURO.0172-25.2025.full.pdf

Treatment of Mitochondrial Disturbances due to Early Life ... These data indicate that mitochondrial health is one component of responses to early life adversity that has life- span implications, but with ...

9. digitalcommons.library.tmc.edu digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=3543&context=uthmed_docs

Mitophagy In Depression - DigitalCommons@TMC Mitochondrial dysfunction and autophagy/mitophagy impairment elicit a heightened inflammatory response, contributing to neurodegenerative.

10. go.drugbank.com go.drugbank.com/conditions/DBCOND0030181

Major Depressive Disorder (MDD) (DBCOND0030181) Cognitive and Mood Assessment Data in Major Depressive Disorder Using Digital Wearable Technology, No drug interventions, Not Available, Not Available ...