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

Completed · Not applicable

Conditions studied: Middle-aged Adults, Major Depressive Disorder

In brief

The goal of this pilot clinical trial is to begin to understand how day-to-day stress affects cardiovascular health and brain function in middle-aged adults. The main question 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 a 15-day testing cycle. During this cycle, participants will complete daily assessments of stress 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.

Key facts

Study ID

NCT06466655

Run by

University of Delaware

People needed

17

Starts

2024-05-30

Expected to finish

2025-05-29

Last updated by the study team

2025-10-02

Who can join

Age: 40 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females aged 40-55 yrs
• Absence of objective cognitive impairment (≥26 on the Montreal Cognitive Assessment)
• Absence of diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases, as determined by medical history, physical examination, blood chemistries, and 12-lead resting electrocardiogram
• 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

You may not qualify if…

• Subjects will be excluded at the discretion of the PI/collaborating clinicians or for any of the following reasons:
• <40 or >55 yrs
• Psychiatric illness aside from MDD (e.g., bipolar disorder, schizophrenia, eating disorders), assessed by the MINI and self-report
• Objective cognitive impairment (<26 on the Montreal Cognitive Assessment)
• Diagnosed or unstable neurocognitive, cardiovascular, metabolic, renal, hepatic, autonomic, autoimmune, or dermatological diseases
• Current or recent use (within 8 wks) of medications that alter cardiovascular function or psychoactive/psychopharmacological drugs
• Body mass index ≥35 kg/m2
• Resting systolic BP ≥140 mmHg
• HbA1c ≥5.7%
• Direct low-density lipoprotein ≥160mg/dl
• Tobacco use (including electronic cigarettes)
• Females who are pregnant, breastfeeding, or planning to become pregnant; female subjects of child-bearing age must have a negative urine pregnancy test on the day of all experimental visits
• Current or past use of hormone replacement therapy
• Allergy to study drugs or pharmacological agents

Where it is running

• University of Delaware — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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