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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to better understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question is aims to answer is whether the link between daily stress and vascular dysfunction is a potential mechanism of increased risk for future cognitive decline. Participants will complete two 15-day "testing cycles" separated by \~6 months. During each cycle, participants will complete two daily assessments of stress and brain health using an online survey tool for 14-consecutive days. On the last day of each cycle, vascular function will be assessed during a laboratory visit.

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.

Research Team

Jody Greaney, PhD

Principal Investigator

University of Delaware

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: MitoTempol Experimental Treatment 1 Intervention

Two intradermal microdialysis probes will be inserted into the dermal layer of the ventral forearm and perfused with either lactated Ringer's solution (control) or MitoTempol (0.5 mM) to scavenge mitochondrial-derived superoxide.

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+