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Acute Plasma Abeta Responses to Stress

Primary Purpose

Stress Reaction, Stress Physiology

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sympathetic Nervous System Activation
No-stress
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stress Reaction focused on measuring Stress Reaction, Stress, Amyloid-Beta

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 18-30 years old or between 50-65 years old
  • 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

Sites / Locations

  • University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Stress (sympathetic nervous system activation)

No-stress

Arm Description

Stress will be induced using the socially evaluated cold pressor test. Participants will complete three rounds of the socially evaluated cold pressor test. The socially evaluated cold pressor test involves submerging one hand in ice-cold water for 3 minutes while participants' reactions are filmed on camera.

Participants will hold a hand in room temperature water for 3 minutes.

Outcomes

Primary Outcome Measures

Plasma amyloid-beta-40
Changes in levels of amyloid-beta-40 in blood from before to after acute intervention (stress/no-stress).
Plasma amyloid-beta-42
Changes in levels of amyloid-beta-42 in blood from before to after acute intervention (stress/no-stress).

Secondary Outcome Measures

Full Information

First Posted
August 26, 2022
Last Updated
June 19, 2023
Sponsor
University of Southern California
Collaborators
Washington University School of Medicine, Keck School of Medicine of USC
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1. Study Identification

Unique Protocol Identification Number
NCT05521919
Brief Title
Acute Plasma Abeta Responses to Stress
Official Title
Effects of Acute Stress Exposure on Plasma Beta-amyloid Levels
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Washington University School of Medicine, Keck School of Medicine of USC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Reaction, Stress Physiology
Keywords
Stress Reaction, Stress, Amyloid-Beta

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will complete one session of each condition: stress and no-stress. Participants will be randomly assigned to one of the two conditions for their first session. Participants will then be randomly assigned to the remaining condition for the second session.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress (sympathetic nervous system activation)
Arm Type
Experimental
Arm Description
Stress will be induced using the socially evaluated cold pressor test. Participants will complete three rounds of the socially evaluated cold pressor test. The socially evaluated cold pressor test involves submerging one hand in ice-cold water for 3 minutes while participants' reactions are filmed on camera.
Arm Title
No-stress
Arm Type
Sham Comparator
Arm Description
Participants will hold a hand in room temperature water for 3 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Sympathetic Nervous System Activation
Intervention Description
Participants will complete a task that increases sympathetic nervous system activation.
Intervention Type
Behavioral
Intervention Name(s)
No-stress
Intervention Description
Participants will complete a task that will not affect their sympathetic nervous system activity.
Primary Outcome Measure Information:
Title
Plasma amyloid-beta-40
Description
Changes in levels of amyloid-beta-40 in blood from before to after acute intervention (stress/no-stress).
Time Frame
9.5 hours
Title
Plasma amyloid-beta-42
Description
Changes in levels of amyloid-beta-42 in blood from before to after acute intervention (stress/no-stress).
Time Frame
9.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lab Manager
Phone
213-740-9543
Email
matherlab@usc.edu
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized data (values of outcome measures and associated experimental conditions) will be shared publicly on Open Science Framework.
IPD Sharing Time Frame
Data will be made available by publication of the paper reporting on the results.
IPD Sharing Access Criteria
Publicly available.

Learn more about this trial

Acute Plasma Abeta Responses to Stress

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