Music Lessons for Mild Cognitive Impairment

(M4M Trial)

Overseen By Rose Lin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Musicality knowledge, Formal music activity, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pilot clinical trial is to learn if older adults with mild cognitive impairment (MCI) find two music programs equally acceptable. This pilot study will help researchers prepare for a future, large-scale clinical trial to learn if music training can slow cognitive decline and promote emotional well-being in those at risk for Alzheimer's disease and related dementias. The main questions this pilot study aims to answer are: * Do participants like the music programs? * Do participants stay enrolled in the study? * Do participants report perceived benefits of the programs for their emotional well-being or everyday memory? Participants will: * Participate in 12-weekly sessions of piano lessons or music lessons, with group and individual lessons alternating each week. * Have home practice in between lessons, with a keyboard or other instruments provided. * Keep a diary of their home practice and their mood before and after practice. * Participate in interviews before and after the 12-week programs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Music Lessons, Piano Lessons for Mild Cognitive Impairment?

Research shows that music interventions, including active music-making and music therapy, can improve cognitive function, emotional well-being, and social engagement in older adults with mild cognitive impairment. Studies have found significant improvements in cognitive tests after music-based interventions, suggesting that music lessons may help enhance cognitive abilities in this population. ^{1 2 3 4 5}

Is participating in music lessons safe for people with mild cognitive impairment?

The available research does not specifically address the safety of music lessons for mild cognitive impairment, but music therapy interventions have been found feasible with high retention rates, suggesting they are generally well-tolerated. ^{1 2 6 7 8}

How do music lessons differ from other treatments for mild cognitive impairment?

Music lessons, such as piano lessons, offer a unique approach by engaging patients in active music-making, which can improve cognitive function and emotional well-being. Unlike traditional treatments, this method uses musical activities to enhance memory and executive functions, providing a non-pharmacological option for managing mild cognitive impairment. ^{1 2 9 10 11}

Eligibility Criteria

This trial is for older adults with mild cognitive impairment or early signs of dementia who are interested in music. They should be willing to attend weekly music lessons, practice at home, and keep a diary of their activities and mood.

Inclusion Criteria

I am 60 years old or older.

I speak English.

Community-dwelling

Exclusion Criteria

Demonstrate musicality knowledge, as assessed by the Musicality Assessment developed by the study team

I have severe problems with my vision or hearing that prevent me from reading music or hearing well.

Currently participating in a formal music activity (performance, classes, lessons, etc.)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in 12-weekly sessions of piano or music lessons, with alternating group and individual lessons, and home practice.

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for satisfaction and acceptability of the music programs through interviews and surveys.

4 weeks

Treatment Details

Interventions

• Music Lessons
• Piano Lessons

Trial Overview The study tests the acceptability of two music programs (piano lessons and general music lessons) for slowing cognitive decline. It involves 12 weeks of alternating group and individual sessions, home practice, diaries, and interviews before/after the program.

Participant Groups

Group I: Piano lessons Experimental Treatment 1 Intervention

Introduction to piano playing, including instruction and practice in note reading, finger positions, and song playing.

Group II: Music lessons Active Control 1 Intervention

Introduction to varied instrument playing, music singing, and music appreciation.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Eastman Performing Arts Medicine Center

Collaborator

Trials

1

Recruited

20+

University of Rochester Aging Institute

Collaborator

Trials

1

Recruited

20+

University of Rochester School of Nursing

Collaborator

Trials

1

Recruited

20+

Findings from Research

Active music-making interventions have a small but statistically significant positive effect on cognitive functioning in older adults with probable mild cognitive impairment (MCI) or dementia, based on a meta-analysis of 21 studies involving 1472 participants.

The review also found that music-making significantly improves emotional well-being, with effect sizes indicating enhanced quality of life and mood, suggesting that these interventions can be beneficial for both cognitive and emotional health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of music participation for mild cognitive impairment and dementia: A systematic review and meta-analysis. Dorris, JL., Neely, S., Terhorst, L., et al.[2022]

In a study of 24 patients with mild cognitive impairment (MCI), a 10-week music therapy intervention using digital devices significantly improved cognitive function, as measured by the Mini-Mental State Examination-Dementia Screening (MMSE-DS) and Montreal Cognitive Assessment-Korean (MOCA-K).

The results indicated that music therapy not only enhanced executive function but also reduced overall disease severity in MCI patients, suggesting that individualized music therapy can be effectively implemented in group settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Intervention with Musical Stimuli Using Digital Devices on Mild Cognitive Impairment: A Pilot Study. Han, E., Park, J., Kim, H., et al.[2020]

Music interventions can significantly enhance cognitive functions such as global cognitive ability, verbal fluency, executive function, and spatial function in older adults with mild cognitive impairment (MCI), based on a review of 11 studies.

Despite the positive effects, the studies varied widely in intervention types and assessment methods, and some had risks of bias, indicating a need for more rigorous research to confirm these benefits and explore specific cognitive domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Music Interventions on Cognitive Function in Older Adults With Mild Cognitive Impairment: A Systematic Review. Kim, J., Cuevas, H., Wood, ST.[2023]

In a pilot study involving 68 elderly participants with mild cognitive impairment, art therapy significantly improved neurocognitive functions compared to a control group, with benefits observed at both 3 and 9 months after the intervention.

No adverse effects were reported from the interventions, suggesting that art therapy is a safe psychosocial approach to enhance cognitive function in older adults with cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Art therapy is associated with sustained improvement in cognitive function in the elderly with mild neurocognitive disorder: findings from a pilot randomized controlled trial for art therapy and music reminiscence activity versus usual care. Mahendran, R., Gandhi, M., Moorakonda, RB., et al.[2019]

The ALMUTH study, a randomized controlled trial involving 18 participants with mild-to-moderate Alzheimer's disease, found that the implementation of music therapy and physical activity was not feasible due to low adherence and high attrition rates, with only 50% of participants attending sessions.

Despite the challenges, no adverse events were reported, and the study has since expanded its recruitment criteria to include individuals with milder memory impairments, aiming to improve feasibility and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 12-month randomised pilot trial of the Alzheimer's and music therapy study: a feasibility assessment of music therapy and physical activity in patients with mild-to-moderate Alzheimer's disease. Matziorinis, AM., Flo, BK., Skouras, S., et al.[2023]

A pilot study involving 16 older adults with mild cognitive impairment showed that a 12-week music therapy intervention significantly improved various cognitive functions, including attention, immediate and delayed memory, and executive function.

The study also found improvements in gait parameters, such as gait velocity and stride length, indicating that music therapy may be an effective and innovative approach to enhance both cognitive and physical abilities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy intervention in community-dwelling older adults with mild cognitive impairment: A pilot study. Domínguez-Chávez, CJ., Murrock, CJ., Guerrero, PIC., et al.[2019]

Playing a musical instrument is associated with a significant reduction in the risk of developing cognitive impairment and dementia, with one study showing musicians were 64% less likely to develop mild cognitive impairment after adjusting for other factors.

A meta-analysis of cohort studies indicated a 59% reduction in dementia risk among those who play musical instruments, suggesting that engaging in music may contribute to cognitive reserve, although the evidence is limited and further research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does playing a musical instrument reduce the incidence of cognitive impairment and dementia? A systematic review and meta-analysis. Walsh, S., Causer, R., Brayne, C.[2021]

In a 48-week trial followed by a 28-week extension study involving 821 patients with amnestic mild cognitive impairment (aMCI), donepezil (10 mg) was found to be generally safe and well-tolerated, with most adverse events being mild to moderate in severity.

The most common side effects included diarrhea, muscle spasms, insomnia, and nausea, with a higher discontinuation rate due to adverse events in the placebo group (22.1%) compared to the donepezil group (10.3%), indicating that donepezil is better tolerated than placebo in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study. Doody, RS., Ferris, S., Salloway, S., et al.[2018]

In a study involving 32 individuals with amnestic mild cognitive impairment (aMCI) and 32 cognitively unimpaired older adults, musical mnemonics using rhythm significantly improved working memory performance compared to spoken presentation.

While rhythm enhanced memory performance, pitch and melody had a negative impact, suggesting that rhythm is a key factor in optimizing memory strategies for individuals with aMCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of musical mnemonics on working memory performance in cognitively unimpaired older adults and persons with amnestic mild cognitive impairment. Derks-Dijkman, MW., Schaefer, RS., Baan-Wessels, L., et al.[2023]

A meta-analysis of 19 studies with 1024 participants showed that music-based interventions significantly improve general cognitive function, executive function, and episodic memory in older adults with mild cognitive impairment (MCI) or dementia.

The findings support the recommendation for increased use of music therapies in various settings, such as homes and nursing facilities, to enhance cognitive health in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Music-Based Intervention on General Cognitive and Executive Functions, and Episodic Memory in People with Mild Cognitive Impairment and Dementia: A Systematic Review and Meta-Analysis of Recent Randomized Controlled Trials. Ito, E., Nouchi, R., Dinet, J., et al.[2022]

In a pilot study involving 10 patients with mild cognitive impairment (MCI), 10 patients with early-stage Alzheimer's disease (AD), and 23 healthy subjects, it was found that while MCI and early AD patients generally performed worse than controls in music memory tasks, they showed unimpaired performance in recognizing chords.

The results suggest that certain aspects of musical memory may be preserved in the early stages of dementia, particularly in individuals with MCI, indicating a potential area for therapeutic focus or cognitive engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Working memory for music in patients with mild cognitive impairment and early stage Alzheimer's disease]. Kerer, M., Marksteiner, J., Hinterhuber, H., et al.[2021]

References

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

Effects of music participation for mild cognitive impairment and dementia: A systematic review and meta-analysis. [2022]

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

Cognitive Intervention with Musical Stimuli Using Digital Devices on Mild Cognitive Impairment: A Pilot Study. [2020]

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

Effect of Music Interventions on Cognitive Function in Older Adults With Mild Cognitive Impairment: A Systematic Review. [2023]

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

Art therapy is associated with sustained improvement in cognitive function in the elderly with mild neurocognitive disorder: findings from a pilot randomized controlled trial for art therapy and music reminiscence activity versus usual care. [2019]

5. England pubmed.ncbi.nlm.nih.gov

A 12-month randomised pilot trial of the Alzheimer's and music therapy study: a feasibility assessment of music therapy and physical activity in patients with mild-to-moderate Alzheimer's disease. [2023]

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

Music therapy intervention in community-dwelling older adults with mild cognitive impairment: A pilot study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Does playing a musical instrument reduce the incidence of cognitive impairment and dementia? A systematic review and meta-analysis. [2021]

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

Safety and tolerability of donepezil in mild cognitive impairment: open-label extension study. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Effects of musical mnemonics on working memory performance in cognitively unimpaired older adults and persons with amnestic mild cognitive impairment. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Music-Based Intervention on General Cognitive and Executive Functions, and Episodic Memory in People with Mild Cognitive Impairment and Dementia: A Systematic Review and Meta-Analysis of Recent Randomized Controlled Trials. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Working memory for music in patients with mild cognitive impairment and early stage Alzheimer's disease]. [2021]