NCT05521919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 5, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

December 10, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

August 26, 2022

Last Update Submit

December 2, 2025

Conditions

Keywords

Stress ReactionStressAmyloid-Beta

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Stress (sympathetic nervous system activation)

EXPERIMENTAL

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.

Behavioral: Sympathetic Nervous System Activation

No-stress

SHAM COMPARATOR

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

Behavioral: No-stress

Interventions

Participants will complete a task that increases sympathetic nervous system activation.

Stress (sympathetic nervous system activation)
No-stressBEHAVIORAL

Participants will complete a task that will not affect their sympathetic nervous system activity.

No-stress

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

MeSH Terms

Conditions

Fractures, StressPlaque, Amyloid

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Gerontology, Psychology, and Biomedical Engineering

Study Record Dates

First Submitted

August 26, 2022

First Posted

August 30, 2022

Study Start

December 5, 2023

Primary Completion

December 10, 2024

Study Completion

December 10, 2024

Last Updated

December 10, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Anonymized data (values of outcome measures and associated experimental conditions) will be shared publicly on Open Science Framework.

Time Frame
Data will be made available by publication of the paper reporting on the results.
Access Criteria
Publicly available.

Locations