Trial Outcomes & Findings for Daily Stress and Vascular Function in Midlife as a Risk Factor for Cognitive Decline (NCT NCT06466655)

Last Updated: 2025-10-02

Results Overview

NO-mediated EDD will be calculated as the relative difference (%) in dilation from the local heating-induced plateau to the post-L-NAME plateau after scavenging mitochondrial-derived superoxide

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Day 15 following a standard local heating protocol, an average of 4 hours during the 15-day cycle

Results posted on

2025-10-02

Participant Flow

We have IRB approval for additional assessments which are being used to address to separate hypotheses and are not contained under this clinical trial.

Participant milestones

Participant milestones
Measure	Middle-aged Healthy Adults (HA) cognitively intact healthy middle-aged adults	Middle-aged Adults With Major Depressive Disorder (MDD) cognitively intact middle-aged adults with major depressive disorder
Overall Study STARTED	9	8
Overall Study COMPLETED	9	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Daily Stress and Vascular Function in Midlife as a Risk Factor for Cognitive Decline

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Middle-aged Healthy Adults n=9 Participants cognitively intact healthy middle-aged adults	Middle-aged Adults With Major Depressive Disorder n=8 Participants cognitively intact middle-aged adults with major depressive disorder	Total n=17 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 4 • n=5 Participants	51 years STANDARD_DEVIATION 4 • n=7 Participants	51 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
body mass index	23.8 kilograms per meter-squared STANDARD_DEVIATION 2.3 • n=5 Participants	26.0 kilograms per meter-squared STANDARD_DEVIATION 3.8 • n=7 Participants	24.9 kilograms per meter-squared STANDARD_DEVIATION 3.2 • n=5 Participants

PRIMARY outcome

Timeframe: Day 15 following a standard local heating protocol, an average of 4 hours during the 15-day cycle

NO-mediated EDD will be calculated as the relative difference (%) in dilation from the local heating-induced plateau to the post-L-NAME plateau after scavenging mitochondrial-derived superoxide

Outcome measures

Outcome measures
Measure	Middle-aged Healthy Adults n=9 Participants cognitively intact middle-aged healthy adults	Middle-aged Adults With Major Depressive Disorder n=8 Participants cognitively intact middle-aged adults with major depressive disorder
Nitric Oxide (NO)-Mediated Endothelium-dependent Dilation (EDD)	70 percentage Standard Deviation 9	74 percentage Standard Deviation 15

SECONDARY outcome

Timeframe: Day 15 following a standard local heating protocol, an average of 4 hours during the 15-day cycle

Population: middle-aged adults

Local heating-induced EDD will be calculated as the relative difference (%) in dilation during the local heating-induced plateau compared to baseline after scavenging mitochondrial-derived superoxide

Outcome measures

Outcome measures
Measure	Middle-aged Healthy Adults n=9 Participants cognitively intact middle-aged healthy adults	Middle-aged Adults With Major Depressive Disorder n=8 Participants cognitively intact middle-aged adults with major depressive disorder
Local Heating-induced Endothelium-dependent Dilation (EDD)	89 percent Standard Deviation 10	93 percent Standard Deviation 11

Adverse Events

Middle-aged Healthy Adults

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Middle-adults With Major Depressive Disorder

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jody Greaney, PhD

University of Delaware

Phone: 3028312193

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place