Mindfulness for Alzheimer's Disease

Overseen By Katherine W Turk, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Boston Healthcare System

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

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

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness meditation can improve memory, brain function, and quality of life in older adults. The study compares individuals attending mindfulness classes with those who do not receive any immediate intervention. It suits older adults experiencing memory issues or mild cognitive challenges. Participants must have access to a computer or smartphone and should not have mood disorders or medical conditions that severely impact thinking. As an unphased trial, this study provides a unique opportunity for participants to contribute to research that could enhance cognitive health in older adults.

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 mindfulness is safe for older adults with and without cognitive impairment?

Research has shown that mindfulness-based stress reduction (MBSR) programs are generally easy for people to handle. In past studies, participants in MBSR courses reported better sleep, less stress, and improved thinking and memory. Major negative effects were not commonly found, suggesting that mindfulness practices are safe for most people.

Mindfulness has been used in various situations, including for individuals at risk for dementia and those with memory concerns. Overall, it is considered safe, with most people experiencing benefits rather than negative effects.

In summary, research suggests that mindfulness is safe and well-tolerated, making it a promising choice for those looking to improve their mental and physical well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness as a treatment for Alzheimer's Disease because it offers a non-drug approach that focuses on mental and physical practices, such as focused attention, body scan exercises, and light chair yoga. Unlike standard treatments that mainly involve medications targeting brain chemistry, mindfulness aims to enhance overall mental well-being and potentially slow cognitive decline through stress reduction and improved focus. This approach is appealing because it might enhance quality of life without the side effects associated with pharmaceuticals, offering a holistic and accessible option for patients.

What evidence suggests that mindfulness might be an effective treatment for Alzheimer's?

Research has shown that mindfulness activities, such as meditation, can improve well-being in individuals with early-stage Alzheimer's and may slow the progression of the condition. In this trial, participants will either take part in a Mindfulness-Based Stress Reduction (MBSR) course or be placed on a Mindfulness Waitlist. Some studies suggest these practices can enhance cognitive skills and might help prevent Alzheimer's. However, not all studies agree, and some have found no significant changes in cognitive skills for older adults who practice mindfulness. Despite mixed results, the potential for mindfulness to enhance well-being and possibly support brain health warrants further investigation. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8328308/

Effectiveness of mindfulness-based interventions for people ... We found no significant effects for mindfulness-based interventions in either the short-term or the medium- to long-term on any outcomes, when compared with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10046197/

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.

3. tandfonline.com tandfonline.com/doi/full/10.1080/07317115.2025.2544933?src=

Long-Term Effects of Mindfulness-Based Stress Reduction ... The current study found that MBSR demonstrated a significant positive impact with large effect sizes on both subjective and objective sleep ...

4. researchprotocols.org researchprotocols.org/2024/1/e64149

A Mindfulness-Based Lifestyle Intervention for Dementia ... Background: Lifestyle behavior change and mindfulness have direct and synergistic effects on cognitive functioning and may prevent Alzheimer ...

5. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2799406

Effects of Mindfulness Training and Exercise on Cognitive ... The findings do not support the use of mindfulness training, exercise, or a combination of both for significantly improving cognitive function in older adults.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7429186/

The Effect of Mindfulness-Based Stress Reduction (MBSR) on ... Mindfulness-based programs have shown a promising effect on several health factors associated with increased risk of dementia and the conversion ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1697260025000997

Impact on cognitive and mental health in older immigrants Mindfulness-based stress reduction (MBSR) has shown benefits for cognition and stress relief. Enhancing these functions may have a ...