Acute Plasma Abeta Responses to Stress

Stress Reaction Clinical Trial

Official title:

Effects of Acute Stress Exposure on Plasma Beta-amyloid Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521919
• Other study ID #: UP-22-00404
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: University of Southern California
• Contact: Lab Manager
• Phone: 213-740-9543
• Email: matherlab[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Research has shown that activation of the sympathetic nervous system for extended periods or during certain times in life can increase the risk for Alzheimer's disease. Some research in animal models show that acute activation of the sympathetic nervous system through stress exposure can increase certain Alzheimer's disease-related biomarkers, such as amyloid-beta, within hours of exposure. However, how acute sympathetic nervous system activation via stress exposure affects amyloid-beta levels in humans has yet to be examined. In this study, the investigators will examine whether brief increases in sympathetic activation result in immediate changes in plasma amyloid-beta levels in the five hours after exposure.

Description:

Aim 1: determine whether acute exposure to stress (increasing sympathetic nervous system activation) increases plasma amyloid-beta-40 and amyloid-beta-42 in the five hours following exposure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy adult weighing at least 110 pounds
• No chronic conditions or illness
• Taking no medications or drugs that might alter the stress response (e.g., corticosteroids, beta-blockers, and others)
• Not using any hormone-containing medication (e.g., hormonal contraceptives, hormone replacement, etc.)
• No contraindications for cold pressor test exposure (high blood pressure, heart disease, dysrhythmia, peripheral vascular disease, any other cardiovascular disorder, diabetes, vasculitis, lupus, tingling or numbness in the hands and/or feet, cryoglobulinemia, and Reynaud's phenomenon)
• No history of fainting during blood draws
• No phobia of having their blood drawn
• No general history of fainting or seizures
• Not currently diagnosed with a mood disorder (e.g., major depressive disorder)
• Not pregnant in the past 12 months
• Not lactating in the past 12 months
• Not trying to become pregnant if premenopausal
• Experienced natural menopause if postmenopausal
• Be non-smokers
• Be fluent in English

Exclusion Criteria:

• Unwilling to be filmed during the stress task OR unwilling to sign the waiver allowing their filmed responses to be used in scientific presentations

Related Conditions & MeSH terms

• Fractures, Stress
• Stress Physiology
• Stress Reaction

Intervention

Behavioral:
• Sympathetic Nervous System Activation
Participants will complete a task that increases sympathetic nervous system activation.
• No-stress
Participants will complete a task that will not affect their sympathetic nervous system activity.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	Keck School of Medicine of USC, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma amyloid-beta-40	Changes in levels of amyloid-beta-40 in blood from before to after acute intervention (stress/no-stress).	9.5 hours
Primary	Plasma amyloid-beta-42	Changes in levels of amyloid-beta-42 in blood from before to after acute intervention (stress/no-stress).	9.5 hours