Mindfulness for Alzheimer's Disease

Overseen By Emotion & Cognition Lab Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Abnormal cardiac rhythm, Arrhythmia, Dyspnea, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily mindfulness practices, combined with heart rate biofeedback, might affect attention, memory, and certain blood markers related to Alzheimer's disease. Participants will follow a specific breathing pattern to either increase or decrease heart rate fluctuations. The trial seeks individuals aged 50-70 who have reliable internet access and can dedicate about 50 minutes daily for 10 weeks. It is suitable for those who haven't recently played Lumosity games and don't have conditions that prevent safe MRI scans. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance cognitive health strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mindfulness practice is safe for Alzheimer's patients?

Research shows that mindfulness practices with slow breathing are safe for participants. These practices can help reduce stress and may improve mental health. Studies suggest that breathing techniques that increase heart rate variability can lower certain blood markers linked to Alzheimer's, indicating potential benefits without harm.

For those practicing to decrease heart rate variability, studies have tested this method in older adults. These tests showed that daily sessions can affect certain brain areas without major safety concerns.

Both methods use biofeedback, which provides real-time information about bodily functions to help adjust breathing. This technique is generally well-tolerated and lacks significant side effects. While more research is always beneficial, current evidence suggests these practices are safe for use in such trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these mindfulness techniques for Alzheimer's because they offer a unique, non-drug approach to managing symptoms. Unlike standard treatments that rely on medications like cholinesterase inhibitors and memantine, these techniques focus on controlling heart rate oscillation through breath-focused mindfulness. The "Increase Oscillation" method encourages breathing at a slow, specific frequency to enhance heart rate variability, potentially improving cognitive function and emotional regulation. Meanwhile, the "Decrease Oscillation" approach adjusts breathing to reduce heart rate variability. This innovative use of biofeedback could provide a promising complementary option for Alzheimer's care by tapping into the body's natural rhythms.

What evidence suggests that this trial's treatments could be effective for Alzheimer's disease?

Research has shown that meditation might help slow brain aging and lower the risk of Alzheimer's disease. In this trial, participants will engage in various mindfulness practices. Those in the "Increase Oscillation" arm will practice techniques that increase heart rate variation through deep and slow breathing, which can greatly improve thinking skills, including memory. Meanwhile, participants in the "Decrease Oscillation" arm will focus on mindfulness practices that reduce heart rate variation. These practices have been found to boost attention, memory, and overall mental well-being in older adults. Both methods offer promising ways to support brain health and improve quality of life, potentially helping to prevent Alzheimer's symptoms from worsening. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Black/African-American or White/European-American individuals aged 50-70 who speak English fluently, have normal vision and hearing (or corrected), check their email regularly, can receive text messages, and are willing to give blood and urine samples. Participants must commit up to an hour daily for 10 weeks.

Inclusion Criteria

I can commit to 60 minutes daily for 10 weeks for the study, besides lab visits.

I regularly check my email account.

I have a phone that can receive texts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention

Participants' baseline measurements are taken, including plasma amyloid-beta levels and brain training performance

1 week

1 visit (in-person)

Intervention

Participants engage in daily mindfulness practice with heart rate biofeedback to either increase or decrease heart rate oscillation

9 weeks

Daily sessions (virtual)

Follow-up

Participants are monitored for changes in plasma amyloid-beta levels and other biomarkers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Daily practice

Trial Overview The CALM study tests how daily mindfulness with heart rate biofeedback affects attention, memory, and Alzheimer's disease biomarkers. It explores the impact of breathing patterns that either stabilize or fluctuate heart rates during meditation.

How Is the Trial Designed?

Group I: Increase Oscillation Experimental Treatment 1 Intervention

Participants will breath at a slow "resonance" frequency during a breath-focused mindfulness practice and receive biofeedback to increase heart rate oscillation.

Group II: Decrease Oscillation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 261 older adults at risk for Alzheimer's disease, higher levels of trait mindfulness were linked to less cognitive decline and lower levels of Alzheimer's-related brain markers, such as amyloid-β and tau.

Specific aspects of mindfulness, like nonjudgment and nonreactivity, were particularly associated with better cognitive performance and reduced Alzheimer's pathology, suggesting that mindfulness may offer protective benefits against cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trait Mindfulness Is Associated With Less Amyloid, Tau, and Cognitive Decline in Individuals at Risk for Alzheimer's Disease. Strikwerda-Brown, C., Ozlen, H., Pichet Binette, A., et al.[2023]

In a two-year study involving Alzheimer's patients, mindfulness practice was found to significantly prevent the onset of depression and other psychological symptoms compared to cognitive stimulation and relaxation therapies.

Mindfulness showed large effect sizes in improving psychological outcomes, making it the recommended non-pharmacological treatment for mild to moderate Alzheimer's disease, alongside standard pharmacological treatment with donepezil.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Prevents Depression and Psychopathology in Elderly People with Mild to Moderate Alzheimer's Disease: A Randomized Clinical Trial. Quintana-Hernández, DJ., Rojas-Hernández, J., Santana-Del Pino, A., et al.[2023]

A meta-analysis of eight randomized controlled trials involving 276 patients found no significant effects of mindfulness-based interventions on anxiety, depression, cognitive function, or quality of life in individuals with dementia and mild cognitive impairment.

The quality of evidence was low due to issues like high risk of bias and small sample sizes, indicating a need for more rigorous and larger studies to better assess the efficacy of mindfulness-based interventions in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of mindfulness-based interventions for people with dementia and mild cognitive impairment: A meta-analysis and implications for future research. Nagaoka, M., Hashimoto, Z., Takeuchi, H., et al.[2021]

Mindfulness and spirituality play a crucial role in improving the quality of life (QoL) for patients with mild Alzheimer's disease (AD) by mediating the effects of functionality, disease awareness, and family satisfaction, based on a study of 128 patients.

Psychological morbidity negatively impacts QoL and is linked to lower awareness of the disease and family satisfaction, suggesting that interventions should focus on enhancing mindfulness and reducing psychological distress to improve overall well-being in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life in patients with mild Alzheimer disease: the mediator role of mindfulness and spirituality. Lima, S., Garrett, C., Machado, JC., et al.[2021]

A two-year study involving 127 Alzheimer's patients showed that a mindfulness-based intervention helped maintain cognitive function and stability, while control and other treatment groups experienced a decline in mental capacities.

The mindfulness program not only stabilized cognitive and functional abilities but also significantly improved behavioral symptoms in patients with mild to moderate Alzheimer's disease, suggesting its potential as an effective complementary treatment for dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of a neuropsychology program based on mindfulness on Alzheimer's disease: randomized double-blind clinical study]. Quintana Hernández, DJ., Miró Barrachina, MT., Ibáñez Fernández, I., et al.[2014]

In a 2-year study involving 23 patients with mild-to-moderate Alzheimer's disease who had not responded well to donepezil alone, the combination of donepezil and the traditional Japanese medicine ninjin'yoeito (NYT) led to significant improvements in cognitive function and mood, as measured by specific assessment scales.

While there were no significant differences in overall cognitive scores between the groups, those receiving the combined treatment showed notable enhancements in cognitive assessments and reductions in depression symptoms over time, indicating that NYT may provide additional benefits when used alongside standard Alzheimer's medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of ninjin'yoeito, a Kampo (traditional Japanese) medicine, on cognitive impairment and depression in patients with Alzheimer's disease: 2 years of observation. Kudoh, C., Arita, R., Honda, M., et al.[2022]

Mindfulness-based interventions (MBIs) significantly improved quality of life, spiritual well-being, and reduced depression in early-stage Alzheimer's dementia patients over six months, as shown by various assessments including the Everyday Cognition scales and Beck Depression Inventory.

In contrast, the control group of untreated patients experienced a significant decline in these same areas, highlighting the potential of MBIs as a beneficial treatment approach for enhancing well-being in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Interventions (MBIs) in Patients with Early-Stage Alzheimer's Disease: A Pilot Study. Giulietti, MV., Spatuzzi, R., Fabbietti, P., et al.[2023]

A randomized controlled trial will assess the effects of a 6-month Mindfulness-Based Interventions (MBIs) program on 80 Alzheimer's patients and their 80 caregivers, focusing on improvements in well-being, mood, and cognitive performance.

Expected outcomes include enhanced quality of life and reduced depression for both patients and caregivers, suggesting that mindfulness training could serve as a beneficial intervention for managing early-stage Alzheimer's and supporting caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of the effects of mindfulness training on quality of life of patients with Alzheimer's disease and their caregivers (Dyad Mindfulness Project). Vespa, A., Fabbietti, P., Giulietti, MV.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4923750/

Stress, Meditation, and Alzheimer's Disease Prevention The results were also positive for focused attention, depression, anxiety, and psychological well-being [67]. This study was conducted in people with no memory ...

2. withpower.com withpower.com/trial/mindfulness-for-alzheimers-disease-00196

Mindfulness for Alzheimer's Disease Trial Overview The CALM study tests how daily mindfulness with heart rate biofeedback affects attention, memory, and Alzheimer's disease biomarkers. It explores ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224022865

Impact of mind-body interventions in older adults with mild ... This review shows that mind-body interventions improved cognitive function and everyday activities functioning, memory, resilience and mindfulness in older ...

4. bbc.com bbc.com/future/article/20230724-can-slow-breathing-guard-against-alzheimers

Can slow breathing guard against Alzheimer's? Breathing exercises may even help to reduce the risk of Alzheimer's disease according to the latest research.

5. mdpi.com mdpi.com/2076-3425/13/3/484

Effects of Mindfulness-Based Interventions (MBIs) in ... Conclusions MBI training is effective in increasing quality of life and preventing worsening in patients with early-stage Alzheimer's dementia. Keywords:.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10516053/

Daily biofeedback to modulate heart rate oscillations affects ... Using data from a clinical trial, we tested the hypothesis that daily sessions modulating heart rate oscillations affect older adults' volume of a region-of- ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-07943-y

study protocol for a randomized controlled trial in older adults We found that increasing parasympathetic activity through daily practice of slow-paced breathing significantly decreased plasma amyloid-β (Aβ) in healthy ...

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13913

“Brain‐IT”: Exergame training with biofeedback breathing in ... This could be achieved by combining simultaneous motor-cognitive training with resonance breathing guided by heart-rate variability biofeedback ...

9. medrxiv.org medrxiv.org/content/10.1101/2025.03.10.25323695v2.full-text

A randomized clinical trial reveals effects of mindfulness ... During some meditative practices, breathing has been shown to slow, thus driving large heart rate oscillations at the breathing frequency ( ...