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?

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.

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.

Is mindfulness safe for people with Alzheimer's disease?

Research suggests that mindfulness practices are generally safe for people with Alzheimer's disease, as studies have shown improvements in quality of life and mood without reporting any significant safety concerns. ^{1 2 3 4 5}

How does the treatment 'Daily practice' differ from other treatments for Alzheimer's disease?

The 'Daily practice' treatment involves mindfulness-based interventions, which focus on being present and aware of thoughts and feelings, potentially improving quality of life and mood in early-stage Alzheimer's patients. Unlike traditional treatments that may focus on medication, this approach emphasizes mental and emotional well-being through regular mindfulness practice. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment Daily practice for Alzheimer's Disease?

Research shows that mindfulness-based interventions can improve quality of life, reduce depression, and prevent worsening of symptoms in patients with early-stage Alzheimer's disease. ^{1 2 5 6 8}

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

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-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]

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]

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 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 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 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]

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. United States 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. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Mindfulness-Based Interventions (MBIs) in Patients with Early-Stage Alzheimer's Disease: A Pilot Study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Quality of life in patients with mild Alzheimer disease: the mediator role of mindfulness and spirituality. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness Prevents Depression and Psychopathology in Elderly People with Mild to Moderate Alzheimer's Disease: A Randomized Clinical Trial. [2023]

5. Spain pubmed.ncbi.nlm.nih.gov

[Effects of a neuropsychology program based on mindfulness on Alzheimer's disease: randomized double-blind clinical study]. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Trait Mindfulness Is Associated With Less Amyloid, Tau, and Cognitive Decline in Individuals at Risk for Alzheimer's Disease. [2023]

7. England 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. [2022]

8. Germany 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). [2022]