Stress ReactionNCT05521919
Acute Plasma Abeta Responses to Stress
A study testing Sympathetic Nervous System Activation and No-stress in people with Stress Reaction and Stress Physiology, run by University of Southern California at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Stress Physiology
- What is being tested?
- Sympathetic Nervous System Activation and No-stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Unwilling to be filmed during the stress task OR unwilling to sign the waiver allowing their filmed responses to be used in scientific presentations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Effects of Acute Stress Exposure on Plasma Beta-amyloid Levels
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.
Read the 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.
- Conditions
- Stress Reaction, Stress Physiology
- Being tested
- Sympathetic Nervous System Activation, No-stress
- Keywords
- Stress Reaction, Stress, Amyloid-Beta
- Medical subject headings
- Fractures, Stress, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sympathetic Nervous System ActivationBehavioural
Participants will complete a task that increases sympathetic nervous system activation.
No-stressBehavioural
Participants will complete a task that will not affect their sympathetic nervous system activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sympathetic Nervous System Activation |
| No-stress | Sham comparator | Participants will hold a hand in room temperature water for 3 minutes. Receives: Behavioral: No-stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amyloid-beta-40
Changes in levels of amyloid-beta-40 in blood from before to after acute intervention (stress/no-stress).
Measured: 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).
Measured: 9.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start5 Dec 2023
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Keck School of Medicine of USC
- Responsible party
- Principal investigator, Mara Mather, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521919
- Sponsor's protocol ID
- UP-22-00404
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data (values of outcome measures and associated experimental conditions) will be shared publicly on Open Science Framework.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute Stress Exposure on Plasma Beta-amyloid Levels
- ClinicalTrials.gov ID
- NCT05521919
- Acronym / sponsor ID
- UP-22-00404
- Conditions
- Stress Reaction, Stress Physiology
- Keywords
- Stress Reaction, Stress, Amyloid-Beta
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Keck School of Medicine of USC
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stress (sympathetic nervous system activation) | Experimental | Behavioral: Sympathetic Nervous System ActivationStress 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. |
| No-stress | Sham comparator | Behavioral: No-stressParticipants will hold a hand in room temperature water for 3 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (1 listed)
- Unwilling to be filmed during the stress task OR unwilling to sign the waiver allowing their filmed responses to be used in scientific presentations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sympathetic Nervous System ActivationParticipants will complete a task that increases sympathetic nervous system activation. | Behavioural | Stress (sympathetic nervous system activation) |
| No-stressParticipants will complete a task that will not affect their sympathetic nervous system activity. | Behavioural | No-stress |
Primary outcome
Plasma amyloid-beta-40
Time frame: 9.5 hours
Changes in levels of amyloid-beta-40 in blood from before to after acute intervention (stress/no-stress).
Plasma amyloid-beta-42
Time frame: 9.5 hours
Changes in levels of amyloid-beta-42 in blood from before to after acute intervention (stress/no-stress).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Yes. Anonymized data (values of outcome measures and associated experimental conditions) will be shared publicly on Open Science Framework.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sympathetic Nervous System Activation and No-stress in people with Stress Reaction and Stress Physiology, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma amyloid-beta-40 (time frame: 9.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.