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MitoTempol for Cognitive Impairment
N/A
Recruiting
Led By Jody Greaney, PhD
Research Sponsored by University of Delaware
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males and females aged 40-55 yrs
Be between 18 and 65 years old
Must not have
Allergy to study drugs or pharmacological agents
Current or past use of hormone replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up following a standard local heating protocol, an average of 4 hours
Awards & highlights
Summary
This trial aims to study how daily stress impacts heart and brain health in middle-aged adults. They want to see if the connection between stress and vascular problems could be a reason for future memory decline. Participants
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects of MitoTempol are not detailed in the provided information. Generally, potential side effects could include reactions at the site of administration, headaches, nausea, or other drug-specific responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 55 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not allergic to any medications used in this study.
Select...
I have used hormone replacement therapy in the past or am currently using it.
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant and can provide a negative pregnancy test.
Select...
I am either younger than 40 or older than 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ following a standard local heating protocol, an average of 4 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~following a standard local heating protocol, an average of 4 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
nitric oxide (NO)-mediated endothelium-dependent dilation (EDD)
Secondary outcome measures
local heating-induced endothelium-dependent dilation (EDD)
Trial Design
1Treatment groups
Experimental Treatment
Group I: MitoTempolExperimental Treatment1 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.
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Who is running the clinical trial?
National Institute of General Medical Sciences (NIGMS)NIH
282 Previous Clinical Trials
248,219 Total Patients Enrolled
University of DelawareLead Sponsor
161 Previous Clinical Trials
25,676 Total Patients Enrolled
Jody Greaney, PhDPrincipal InvestigatorUniversity of Delaware
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