Alzheimer DiseaseNCT06210035
Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease
A study testing Belly-focus meditation and Belly-focus meditation with slow breathing in people with Alzheimer Disease, run by University of Southern California at 1 site in United States.
Trial summary
In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD). We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Belly-focus meditation and Belly-focus meditation with slow breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 3 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent in English
- Aged between 18-35 years old
- Agree to provide blood samples
- Healthy adults who weigh at least 110 pounds
- Agree to devote 40 minutes daily to this study for a week
Who cannot join
- Have a disorder that would affect heart rhythm or function (e.g., abnormal cardiac rhythm, dyspnea, heart disease including coronary artery disease, angina and arrhythmia)
- Regularly practicing any relaxation, meditation or yoga that involve breathing focused practices lasting for more than an hour each week
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD). We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory. Healthy adults aged 18-35 who meet all eligibility criteria will be invited to this study. Participants will be asked to engage in one week of daily meditation practice or no-intervention control task at home. They will also be asked to visit the lab twice, once before and once after the intervention, to provide blood samples to assess plasma biomarkers of AD and to complete emotion questionnaires and a memory test.
- Conditions
- Alzheimer Disease
- Being tested
- Belly-focus meditation, Belly-focus meditation with slow breathing
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belly-focus meditationBehavioural
Participants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly.
Belly-focus meditation with slow breathingBehavioural
Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly.
| Study group | Role | What they receive |
|---|---|---|
| Belly-focus concentration meditation | Experimental | Participants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly. Receives: Behavioral: Belly-focus meditation |
| Belly-focus concentration meditation with slow breathing | Experimental | Participants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly. Receives: Behavioral: Belly-focus meditation with slow breathing |
| No-intervention control | No intervention | Participants will rest quietly for 40 minutes every day for a week while recording heart rate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Plasma Amyloid Beta (Aβ) Levels
The investigators computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). They conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.
Measured: Measured from blood draws before and after a one-week intervention
Change in Plasma Ab42/40 Ratio
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma Ab42/40 ratios. The plasma Ab42/40 ratio was calculated by dividing the plasma Ab42 concentration (pg/ml) by the plasma Ab40 concentration (pg/ml). A higher plasma Ab42/40 ratio indicates better outcome (i.e., greater brain clearance).
Measured: Measured from blood draws before and after a one-week intervention
Secondary outcomes (2)
Change in Plasma pTau-181/Tau Ratio
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma pTau-181/total Tau ratios. The plasma pTau-181/total Tau ratio was calculated by dividing the plasma pTau-181 concentration (pg/ml) by the plasma total Tau concentration (pg/ml). A higher plasma pTau-181/total Tau ratio indicates better outcome (i.e., greater brain clearance).
Measured: Measured from blood draws before and after a one-week intervention
Change in Emotional Well-being
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on emotional well-being. Emotional well-being was assessed using the Profile of Mood States (POMS), which consists of 40 items rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Total Mood Disturbance (TMD) scores were calculated by summing the negative mood items and subtracting the sum of the positive mood items. A constant of 100 was added to the TMD score to eliminate negative values. Higher scores indicate more negative mood states, with possible scores ranging from 56 to 216.
Measured: Measured before and after a one-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start29 Jan 2024
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer DiseaseStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Principal investigator, Mara Mather, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210035
- Sponsor's protocol ID
- UP-23-00373
- Status last verified
- Dec 2025
- First submitted
- 20 Oct 2023
- Last updated
- 5 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heart Rate Oscillations During Meditation on Plasma Biomarkers of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06210035
- Acronym / sponsor ID
- UP-23-00373
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Posted 5 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the current study, we will examine how two types of concentration meditation practices affect plasma biomarkers of Alzheimer's Disease (AD). We will also examine the effects of the two types of meditation practices on emotional well-being and episodic memory. Healthy adults aged 18-35 who meet all eligibility criteria will be invited to this study. Participants will be asked to engage in one week of daily meditation practice or no-intervention control task at home. They will also be asked to visit the lab twice, once before and once after the intervention, to provide blood samples to assess plasma biomarkers of AD and to complete emotion questionnaires and a memory test.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Belly-focus concentration meditation | Experimental | Behavioral: Belly-focus meditationParticipants will engage in concentration meditation for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly. |
| Belly-focus concentration meditation with slow breathing | Experimental | Behavioral: Belly-focus meditation with slow breathingParticipants will engage in concentration meditation and slow breathing for 40 minutes every day for a week while recording heart rate. They will focus on the sensations around the belly while breathing slowly. |
| No-intervention control | No intervention | –Participants will rest quietly for 40 minutes every day for a week while recording heart rate. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Fluent in English
- Aged between 18-35 years old
- Agree to provide blood samples
- Healthy adults who weigh at least 110 pounds
- Agree to devote 40 minutes daily to this study for a week
Key exclusion criteria (2 listed)
- Have a disorder that would affect heart rhythm or function (e.g., abnormal cardiac rhythm, dyspnea, heart disease including coronary artery disease, angina and arrhythmia)
- Regularly practicing any relaxation, meditation or yoga that involve breathing focused practices lasting for more than an hour each week
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 |
|---|---|---|
| Belly-focus meditationParticipants will engage in concentration meditation for 40 minutes every day for a week. They will focus on the sensations around the belly. | Behavioural | Belly-focus concentration meditation |
| Belly-focus meditation with slow breathingParticipants will engage in concentration meditation and slow breathing for 40 minutes every day for a week. They will focus on the sensations around the belly while breathing slowly. | Behavioural | Belly-focus concentration meditation with slow breathing |
Primary outcome
Change in Plasma Amyloid Beta (Aβ) Levels
Time frame: Measured from blood draws before and after a one-week intervention
The investigators computed an aggregate Z-score based on plasma Aβ40 and Aβ42 levels (pg/mL). A Z-score of 0 represents the sample mean. Higher values indicate a greater level of plasma Aβ, which in cognitively normal individuals has been found to be associated with a higher risk of converting to Alzheimer's disease (Song et al., 2011). They conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for a time × condition interaction in plasma Aβ levels, assessing group differences in change over time.
Change in Plasma Ab42/40 Ratio
Time frame: Measured from blood draws before and after a one-week intervention
The investigators conducted a 2 (time: pre, post) × 3 (condition) ANOVA to test for an interaction effect on plasma Ab42/40 ratios. The plasma Ab42/40 ratio was calculated by dividing the plasma Ab42 concentration (pg/ml) by the plasma Ab40 concentration (pg/ml). A higher plasma Ab42/40 ratio indicates better outcome (i.e., greater brain clearance).
2 secondary outcomes
Change in Plasma pTau-181/Tau Ratio
Time frame: Measured from blood draws before and after a one-week intervention
Change in Emotional Well-being
Time frame: Measured before and after a one-week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Belly-focus meditation and Belly-focus meditation with slow breathing in people with Alzheimer Disease, 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 5 inclusion and 2 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 5 Jan 2026. 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. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Plasma Amyloid Beta (Aβ) Levels (time frame: Measured from blood draws before and after a one-week intervention). 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 5 Jan 2026.