Menu
Recruiting NCT06410157

Cardiac-Control Affecting Learning Through Mindfulness (CALM)

No phase Interventional Age-related Cognitive Decline Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Daily practice.
Who it may be relevant to
Registry conditions: Age-related Cognitive Decline, Alzheimer Disease. Basic parameters: 50 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Daily practice
    Participants will be asked to undergo daily mindfulness practice while regulating (either increase or decrease) heart rate oscillation.

Primary outcome measures

  • Change in plasma amyloid-beta 42 levels [Time frame: Week 1 and Week 10]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Southern California — Los Angeles

Identifiers

NCT: NCT06410157 · UP-21-00357-main · R01AG080652

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗