Age-related Cognitive DeclineNCT06410157
Cardiac-Control Affecting Learning Through Mindfulness (CALM)
A study testing Daily practice in people with Age-related Cognitive Decline and Alzheimer Disease, run by University of Southern California at 1 site in United States.
Trial summary
Some types of meditation lead heart rate to become more steady as breathing quiets whereas others lead to large heart rate swings up and down (oscillations) as breathing becomes deeper and slower. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline, Alzheimer Disease
- What is being tested?
- Daily practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2025to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fluent in English
- Black/African-American or White/European-American
- Aged between 50-70 years old
- Non-pregnant and non-menstruating (for at least the past year)
- Have normal or corrected-to-normal vision and hearing
- Have reliable access to wifi
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- Have an email account that you check regularly
- Have a phone that receives text messages
- Agree to provide blood and urine samples at two campus visits
- Agree to devote up to 50 minutes daily to this study for 10 weeks as well as attend two campus visits
Who cannot join
- Have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, arrhythmia, dyspnea)
- Have cognitive impairment
- Have regularly played Lumosity games in the past 6 months
- Have any conditions listed below that are not safe for MRI
- *Metal in any parts of your body
- Claustrophobia
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- Have worked as a machinist, metal worker, or in any profession or hobby grinding metal?
- Have had an injury to the eye involving a metallic object (e.g., metallic slivers, shavings, or foreign body)
- Cardiac pacemaker
- Implanted cardiac defibrillator
- Aneurysm clip or brain clip
- Carotid artery vascular clamp
- Neurostimulator
- Insulin or infusion pump
- Spinal fusion stimulator
- Cochlear, otologic, ear tubes or ear implant
- Prosthesis (eye/orbital, penile, etc.)
- Implant held in place by a magnet
- Heart valve prosthesis
- Artificial limb or joint
- Other implants in body or head
- Electrodes (on body, head or brain)
- Intravascular stents, filters
- Shunt (spinal or intraventricular)
- Vascular access port or catheters
- IUD
- Transdermal delivery system or other types of foil patches (e.g., Nitro, Nicotine, Birth control, etc.) that cannot be removed for MRI
- Shrapnel, buckshot, or bullets
- Tattooed eyeliner or eyebrows
- Body piercing(s) that cannot be removed for MRI
- Metal fragments (eye, head, ear, skin)
- Internal pacing wires
- Aortic clips
- Metal or wire mesh implants
- Wire sutures or surgical staples
- Harrington rods (spine)
- Bone/joint pin, screw, nail, wire, plate
- Wig or toupee that cannot be removed for MRI
- Hair implants that involve staples or metal
- Hearing aid(s) that cannot be removed for MRI
- Dentures or retainers that cannot be removed for MRI
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90089
Emotion & Cognition Lab Coordinator, 213-740-9543, matherlab@usc.edu
About this study
Some types of meditation lead heart rate to become more steady as breathing quiets whereas others lead to large heart rate swings up and down (oscillations) as breathing becomes deeper and slower. The current study is designed to investigate how daily mindfulness practice with heart rate biofeedback during breathing in a pattern that either increases or decreases heart rate oscillation affect attention and memory and blood biomarkers associated with Alzheimer's disease.
- Conditions
- Age-related Cognitive Decline, Alzheimer Disease
- Being tested
- Daily practice
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily practiceBehavioural
Participants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation.
| Study group | Role | What they receive |
|---|---|---|
| Increase Oscillation | Experimental | Participants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation. Receives: Behavioral: Daily practice |
| Decrease Oscillation | Experimental | Participants' breathing will not be fixed to particular frequency during a breath-focused mindfulness practice and they will receive biofeedback to decrease heart rate oscillation. Receives: Behavioral: Daily practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma amyloid-beta 42 levels
Plasma Ab42 levels will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab 42 levels (to assess group differences in change).
Measured: Week 1 and Week 10
Secondary outcomes (5)
Plasma amyloid-beta 40 levels
Plasma Ab40 levels will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab 40 levels (to assess group differences in change).
Measured: Week 1 and Week 10
Plasma Ab42/40 ratio
Investigators will test for a time X condition interaction with plasma Ab42/40 ratio values as the dependent variable (to assess group differences in change).
Measured: Week 1 and Week 10
Plasma pTau-181/tTau ratio
Investigators will test for a time X condition interaction with the ratio of pTau-181 and total tau values as the dependent variable (to assess group differences in change).
Measured: Week 1 and Week 10
Change in brain perivascular space volume
Investigators will test for a time X condition interaction in perivascular space volume.
Measured: Week 1 and Week 10
Brain training performance on Lumosity games during the breathing intervention
Investigators will compute a general learning factor across performance on all games played daily during the intervention period (Weeks 2-10) and separately across performance on all games played daily before the intervention period (Week 1). Investigators will test for group differences in performance during the intervention, controlling for performance before the intervention.
Measured: During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start14 Jan 2025
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mara Mather, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410157
- Sponsor's protocol ID
- UP-21-00357-main
- Other IDs
- R01AG080652
- Status last verified
- May 2026
- First submitted
- 6 May 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual scores associated with the primary and secondary outcomes will be shared. Functional and structural brain images will be shared. Lumosity game play data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac-Control Affecting Learning Through Mindfulness (CALM)
- ClinicalTrials.gov ID
- NCT06410157
- Acronym / sponsor ID
- UP-21-00357-main
- Conditions
- Age-related Cognitive Decline, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of California, Irvine, National Institute on Aging (NIA)
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 13 May 2024 (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.
Some types of meditation lead heart rate to become more steady as breathing quiets whereas others lead to large heart rate swings up and down (oscillations) as breathing becomes deeper and slower. The current study is designed to investigate how daily mindfulness practice with heart rate biofeedback during breathing in a pattern that either increases or decreases heart rate oscillation affect attention and memory and blood biomarkers associated with Alzheimer's disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increase Oscillation | Experimental | Behavioral: Daily practiceParticipants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation. |
| Decrease Oscillation | Experimental | Behavioral: Daily practiceParticipants' breathing will not be fixed to particular frequency during a breath-focused mindfulness practice and they will receive biofeedback to decrease heart rate oscillation. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Fluent in English
- Black/African-American or White/European-American
- Aged between 50-70 years old
- Non-pregnant and non-menstruating (for at least the past year)
- Have normal or corrected-to-normal vision and hearing
Key exclusion criteria (41 listed)
- Have a disorder that would impede performing the breathing intervention (e.g., abnormal cardiac rhythm, arrhythmia, dyspnea)
- Have cognitive impairment
- Have regularly played Lumosity games in the past 6 months
- Have any conditions listed below that are not safe for MRI
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 |
|---|---|---|
| Daily practiceParticipants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation. | Behavioural | Decrease Oscillation, Increase Oscillation |
Primary outcome
Change in plasma amyloid-beta 42 levels
Time frame: Week 1 and Week 10
Plasma Ab42 levels will be compared for Week 1 (pre-intervention) and Week 10 (post-intervention). Investigators will test for a time X condition interaction in plasma Ab 42 levels (to assess group differences in change).
5 secondary outcomes
Plasma amyloid-beta 40 levels
Time frame: Week 1 and Week 10
Plasma Ab42/40 ratio
Time frame: Week 1 and Week 10
Plasma pTau-181/tTau ratio
Time frame: Week 1 and Week 10
Change in brain perivascular space volume
Time frame: Week 1 and Week 10
Brain training performance on Lumosity games during the breathing intervention
Time frame: During intervention (daily during Weeks 2-10) and before intervention (daily during Week 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. All individual scores associated with the primary and secondary outcomes will be shared. Functional and structural brain images will be shared. Lumosity game play data will be shared.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily practice in people with Age-related Cognitive Decline and 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 10 inclusion and 41 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: looking for participants now, as of the sponsor's last update on 13 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emotion & Cognition Lab Coordinator (213-740-9543, matherlab@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plasma amyloid-beta 42 levels (time frame: Week 1 and Week 10). 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 13 May 2026.