Mindfulness for Alzheimer's Disease

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Boston Healthcare System

Disqualifiers: Mood disorders, Alcohol and drug use, Cerebrovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are: 1. How does mindfulness impact thinking and memory? 2. How does mindfulness influence brain function and structure? 3. How does mindfulness affect daily function and quality of life? Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group). Participants will: * Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist) * Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention Outcomes will be assess at baseline, 2 months, 4 months and 6 months.

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 data supports the effectiveness of the treatment Mindfulness for Alzheimer's Disease?

Research shows that mindfulness can improve quality of life, reduce depression, and prevent worsening of symptoms in people with early-stage Alzheimer's disease. It helps patients become more aware of their thoughts and feelings, which can lead to better mood and well-being. ^{1 2 3 4 5}

Is mindfulness safe for people with Alzheimer's disease?

Research suggests that mindfulness is generally safe for people with Alzheimer's disease, as it has been shown to improve quality of life and mood without reported adverse effects. ^{1 3 5 6 7}

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

Mindfulness is unique because it focuses on improving quality of life and emotional well-being by encouraging patients to be aware of their thoughts and feelings in the present moment. Unlike traditional treatments that may target cognitive symptoms directly, mindfulness aims to enhance mood and prevent depression, offering a holistic approach to managing early-stage Alzheimer's disease. ^{1 3 4 5 6}

Research Team

Eligibility Criteria

This trial is for older adults with early-stage Alzheimer's or mild cognitive impairment, as well as those experiencing normal aging. Participants should be willing to undergo cognitive testing and neuroimaging. People with subcortical brain damage or traumatic brain injury may also qualify.

Inclusion Criteria

I have mild memory problems but can still take care of myself.

My cognitive abilities are within the normal range for my age and education level.

Exclusion Criteria

Participants with mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years

Participants without a computer, smart phone and internet access will be excluded

I have a brain blood vessel condition.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Intervention

Participants engage in a mindfulness class intervention including focused attention, body scan practice, and light chair yoga

10 weeks

Regular sessions as part of the mindfulness course

Waitlist Control

Participants in the waitlist group do not engage in any active interventions for 2 months, then begin the mindfulness intervention

2 months

Follow-up

Participants are monitored for cognitive and quality of life outcomes after the intervention

6 months

Assessments at baseline, 2 months, 4 months, and 6 months

Treatment Details

Interventions

• Mindfulness (Behavioral Intervention)

Trial Overview The study tests if mindfulness meditation can improve thinking, memory, brain function and structure, daily function, and quality of life in older adults. It compares a group receiving mindfulness training against a waitlisted group that receives no immediate intervention.

Participant Groups

Group I: Mindfulness Experimental Treatment 2 Interventions

MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.

Group II: Mindfulness Waitlist Active Control 1 Intervention

Individuals in the Mindfulness Waitlist group will not engage in any of the study interventions until 2 months has passed. Then they will be enrolled in the Mindfulness Intervention.

Who Is Running the Clinical Trial?

VA Boston Healthcare System

Lead Sponsor

Trials

73

Recruited

971,000+

Findings from Research

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 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]

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]

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 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]

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]

Mindfulness meditation for insomnia (MAP-I) is significantly more cost-effective than cognitive behavioral therapy for insomnia (CBT-I), with savings of $2094 (53%) per caregiver for individual delivery and $604 (30%) for group delivery.

The ongoing trial suggests that MAP-I not only provides effective treatment for insomnia in Alzheimer's caregivers but also offers substantial cost savings for both society and the healthcare system, highlighting its potential for broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs associated with treatment of insomnia in Alzheimer's disease caregivers: a comparison of mindfulness meditation and cognitive behavioral therapy for insomnia. Bentley, TGK., Castillo, D., Sadeghi, N., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

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

2. 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]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

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

5. 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]

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

Costs associated with treatment of insomnia in Alzheimer's disease caregivers: a comparison of mindfulness meditation and cognitive behavioral therapy for insomnia. [2022]