Music-Based Interventions for Alzheimer's Disease

Overseen By Assal Habibi, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Disqualifiers: Severe hearing loss, Neurological, Psychiatric, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how engaging with music, such as singing in a choir or listening to music, can improve hearing, communication, and well-being in older adults at higher risk of developing dementia. Participants will either join a choir group to sing and learn about music or a music-listening group to discuss and reflect on songs. This music-based intervention aims to determine if music can support those facing memory and communication challenges. Individuals fluent in English, able to hear and see well with or without aids, and without a history of severe hearing loss or major mental health issues may be suitable for this study. As an unphased trial, this study offers a unique opportunity to explore innovative ways music can enhance quality of life.

Do I need to stop my current medications for the trial?

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

What prior data suggests that music-based interventions are safe for older adults?

Research shows that music activities, like singing in a choir, are generally well-received by people with dementia. Studies have found that joining choir sessions can lift mood and improve emotional well-being. For instance, one study discovered that singing for 10 weeks helped dementia patients feel happier and more oriented. Another study suggested that choir singing boosts self-reported well-being.

While the findings are encouraging, some studies did not find a significant change in quality of life from singing activities. However, no major negative effects were reported, indicating that choir singing is safe for participants.

For the music listening activity, specific data is limited. However, listening to music is a common and safe pastime. Overall, the music-based activities in this trial appear safe and enjoyable for those at risk of dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music-based interventions for Alzheimer's disease because they offer a non-pharmacological approach that taps into the emotional and cognitive pathways of the brain. Unlike standard treatments, which often involve medications like cholinesterase inhibitors and memantine, these interventions use music to stimulate memory and cognitive functions. The Choir arm provides an interactive and socially engaging experience, encouraging participants to sing and learn music collaboratively, which can boost mood and social connections. Meanwhile, the Music Listening arm focuses on personal reflections and cultural discussions, potentially enhancing emotional well-being and cognitive engagement without the side effects associated with drugs.

What evidence suggests that music-based interventions could be effective for Alzheimer's disease?

Research has shown that music therapy can help people with Alzheimer's disease by improving mood and reducing depression and anxiety. In this trial, participants will engage in different music-based interventions. One group will join a choir, which studies have found can enhance mental abilities like memory and speaking skills, while also benefiting emotional health by lowering anxiety and depression levels. Specifically, choir sessions have been linked to noticeable decreases in symptoms of depression and anxiety. Another group will participate in music listening sessions, which aim to improve quality of life. Overall, music-based activities appear promising in enhancing the quality of life for those at risk of dementia. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults with good vision and hearing (aided if necessary) who speak English fluently. It's especially aimed at those at risk of dementia, including Alzheimer's Disease, to see how music activities like choir singing or group listening might help with communication and well-being.

Inclusion Criteria

Language Proficiency: Fluency in English to ensure complete testing

I can see and hear well, with glasses or hearing aids if needed.

Exclusion Criteria

Cognitive Function: Impaired cognitive function, indicated by a score of less than 26 on the Montreal Cognitive Assessment (MoCA)

Hearing Loss: Severe hearing loss not correctable with aids

Medical Conditions: Unstable or serious medical conditions that could limit participation in assessments or weekly meetings

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either a community choir program or a music listening program for 16 weeks

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Music-Based Interventions

Trial Overview

The study is testing whether joining a choir or participating in group music listening sessions can improve hearing, speech perception, reduce anxiety, and enhance social behavior in older adults. Participants will be randomly assigned to these activities to measure the effects.

How Is the Trial Designed?

Group I: Choir Experimental Treatment 1 Intervention

For each choir session, the choir director will be supported by an accompanist who will provide the music accompaniment for the songs and four section leaders who will provide musical leadership for choral sections (soprano, alto tenor \& bass). At the beginning of each choir group, participants will be asked about their favorite songs to help ensure that the music will be appropriate for the participants' interest and cultural background. Each choir group will rehearse once a week for two hours with a short break in the middle for snacks for a total of 16 consecutive weeks. The choir rehearsals will follow a general routine, beginning with announcements and warm-ups, work on the repertoire, a break, additional work on the repertoire in sections, and a short group practice at the end. Participants will also be given at-home activities, in the form of pre-recorded videos and music theory exercises to complete outside of class for an estimated 1.5 hours per week.

Group II: Music Listening Active Control 1 Intervention

Over the course of 16-weeks, the group will meet for two hours per week to talk about a set of musical recordings. Recorded music will be previously assigned and provided as a playlist via a web platform to track the time duration of engagement. Regular attendance will be required. The discussion group will meet as a full group each week to listen to a subset of that week's recordings, with a guided and brief discussion after each of the six selected songs. The group will then pause for a brief break and will divide into four smaller discussion groups where a volunteer facilitator from that group would guide a discussion about the selected music, to include personal reflections, its cultural context, and ideas around societal impacts.

Music-Based Interventions is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Music Therapy for:

• Alzheimer's disease management
• Dementia symptom relief
• Cognitive function improvement

Approved in United States as Music-Based Interventions for:

• Behavioral symptom management in dementia
• Improvement in communication and caregiver relationships
• Enhancement of emotional well-being

Approved in Canada as Music-Based Interventions for:

• Management of behavioral and psychological symptoms of dementia
• Enhancement of cognitive function

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

Current research on music therapy for dementia lacks rigorous methodological design, making it difficult to draw definitive conclusions about its effectiveness.

Despite the absence of strong empirical evidence, the available studies suggest that music therapy may have potential benefits in managing dementia symptoms, highlighting the need for more well-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for dementia symptoms. Koger, SM., Brotons, M.[2020]

A 10-week music therapy program for five patients with early-stage Alzheimer's disease significantly reduced anxiety levels (from 9.4 to 3.4 on the Hamilton scale) and depression levels (from 10.8 to 2.2 on the Cornell scale), demonstrating its efficacy in improving emotional well-being.

The therapy also alleviated the emotional and physical burden on caregivers, with their burden score dropping from 30.2 to 15.6 on the Zarit scale, indicating that music therapy can benefit both patients and their caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of music therapy on anxiety and depression for patients with Alzheimer's disease and on the burden felt by the main caregiver (feasibility study)]. Guetin, S., Portet, F., Picot, MC., et al.[2009]

Music therapy can provide therapeutic benefits for patients with Alzheimer's dementia by improving their overall well-being and potentially reflecting their progress in managing the disease.

Engaging in music therapy sessions may help alleviate some cognitive disorders associated with Alzheimer's, enhancing the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy and Alzheimer disease]. Tromeur, E.[2014]

Research is needed to understand how music therapy can impact the behavior of elderly Alzheimer's patients, focusing on both immediate and long-term effects.

The Music Therapy Assessment Tool (MTAT) has shown promising reliability in preliminary tests, making it a valuable tool for evaluating the effects of music therapy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The music therapy assessment tool in Alzheimer's patients. Glynn, NJ.[2019]

Music therapy has shown positive effects for individuals with Alzheimer's disease, helping to reduce anxiety, depression, and aggressive behavior while improving mood, communication, and autonomy.

The therapy works through emotional and psycho-physiological pathways, and it can help maintain or rehabilitate cognitive, sensory, emotional, and social skills in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of the use of music therapy in the context of Alzheimer's disease: a report of a French expert group. Guetin, S., Charras, K., Berard, A., et al.[2022]

Active music-making can serve as an effective therapy for Alzheimer's patients, helping to maintain cognitive functions and improve quality of life through social interaction and self-expression.

Music therapy may reduce the need for tranquilizers and hypnotics, promoting mood improvement and enhancing mental processes, suggesting it could be a valuable part of rehabilitation strategies for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's disease: rhythm, timing and music as therapy. Aldridge, D.[2022]

Current research on music therapy for dementia lacks rigorous methodological design, making it difficult to draw strong conclusions about its effectiveness.

Despite the absence of reliable empirical evidence, existing studies suggest that music therapy may have potential benefits in managing dementia symptoms, highlighting the need for better-designed research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for dementia symptoms. Koger, SM., Brotons, M.[2018]

In a study involving 41 mild Alzheimer's disease patients over 6 months, music therapy (MT) did not show significant overall cognitive benefits compared to a control group, but it did improve performance in the abstraction domain of cognitive abilities.

The findings suggest that while MT may not enhance global cognition or daily functioning, it can serve as a valuable supplementary treatment for specific cognitive aspects in Alzheimer's patients under pharmacological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunct effect of music therapy on cognition in Alzheimer's disease in Taiwan: a pilot study. Li, CH., Liu, CK., Yang, YH., et al.[2020]

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