Music Therapy for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Joanne V Loewy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Other dementia, Stroke, Epilepsy, Major psychiatric disorder, others

Compensation: Varies

Number of Visits: 52

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of music therapy can improve memory and language skills in people with Alzheimer's disease or Mild Cognitive Impairment. Participants will engage in one of three activities: home-based singing sessions (Home-based Music Therapy through Supervised, Supported Singing, or H3S), a combination of singing and personalized music therapy (Individualized Music Therapy, or IMT), or activities that mimic the attention given in the therapy sessions (Attention Control, or AtCon). The researchers aim to assess how these experiences affect cognition (thinking and memory) and quality of life over 12 months. Individuals with Alzheimer's or Mild Cognitive Impairment who live in the community, speak English, and have a smartphone or webcam may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance therapeutic options for memory and language improvement.

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 study team or your doctor.

What prior data suggests that these music therapy experiences are safe for Alzheimer's patients?

Research has shown that home-based music therapy, such as Supervised Supported Singing (H3S), is safe for individuals with dementia and similar conditions. One study found that these activities did not cause any serious side effects, as no harmful effects were reported.

For Individualized Music Therapy (IMT), research also indicates safety. Studies suggest it can help reduce restlessness and the need for some medications in patients with Alzheimer's and related disorders, showing it is well-tolerated and does not cause harm.

Overall, both H3S and IMT appear to be safe options for those with Alzheimer's or mild cognitive impairment, with no major safety concerns reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about music therapy for Alzheimer's disease because it offers a non-drug approach with potentially fewer side effects compared to standard medications like cholinesterase inhibitors. The unique aspect of Home-based Music Therapy through Supervised, Supported Singing (H3S) is its ability to engage patients in a familiar, comforting activity that may enhance mood and cognitive function through active participation. Combining this with Individualized Music Therapy (IMT) can offer a tailored experience that addresses personal preferences, potentially leading to better patient engagement and outcomes. These music-based approaches aim to provide emotional and cognitive benefits in a more natural and enjoyable way.

What evidence suggests that this trial's music therapy treatments could be effective for Alzheimer's disease?

Research has shown that music therapy can help people with Alzheimer's disease. In this trial, participants may receive Home-based music therapy through Supervised, Supported Singing (H3S), which can help maintain mental sharpness and improve quality of life. Studies also suggest it can lower stress hormones, potentially benefiting brain health. Another treatment option in this trial is Individualized Music Therapy (IMT), which shows promise, with evidence of improved thinking skills and reduced agitation in dementia patients. Both therapies have been linked to positive changes in behavior, mood, and memory, which are important for managing Alzheimer's disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Joanne V Loewy

Principal Investigator

Mount Sinai Beth Israel

Mary Sano, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals with Alzheimer's or mild cognitive impairment who have a study partner and can use a webcam or smartphone. They must be able to communicate verbally, live in the community, and not have significant health issues that could interfere with the study.

Inclusion Criteria

You have been diagnosed with Alzheimer's disease or mild cognitive impairment.

Must have study partner

Must be English speaking

Exclusion Criteria

Likely Alzheimer's disease in someone with Down syndrome.

You have had a major stroke that caused lasting problems.

You have had epilepsy, a specific type of brain problem, or a head injury within the past two years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or remote)

Baseline Assessment

Participants undergo baseline testing including cognitive and linguistic analyses

1-2 weeks

1 visit (in-person or remote)

Treatment

Participants receive music therapy interventions, with contact up to twice per week for the first six months

6 months

Up to 48 visits (in-person or remote)

Follow-up

Participants are monitored for cognitive testing and medical review every three months

6 months

2 visits (in-person or remote)

What Are the Treatments Tested in This Trial?

Interventions

• Attention Control (AtCon)
• Home-based MT through Supervised, Supported Singing (H3S)
• Individualized Music Therapy (IMT)

Trial Overview The study compares home-based music therapy through singing (H3S), individualized music therapy (IMT), and an attention control group involving pleasant events without music. It aims to see how these affect memory, language, and quality of life over 12 months.

How Is the Trial Designed?

Group I: Home-based MT through Supervised, Supported Singing (H3S) Experimental Treatment 1 Intervention

Treatment arm 1

Group II: H3S and IMT Experimental Treatment 2 Interventions

Treatment arm 2 received both Home-based Supervised, Supported Singing (H3S) and Individualized Music Therapy (IMT)

Group III: Attention Control (AtCon) Placebo Group 1 Intervention

Comparison condition with comparable attention

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

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]

In a study involving seven participants, including six with probable Alzheimer's disease, exercise sessions led to significantly more purposeful responses compared to sing-along sessions, suggesting that physical activity may engage dementia patients more effectively.

Individual differences in responses were noted, with one participant showing low exercise participation but similar singing scores to others, highlighting the need for tailored approaches in music therapy for dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Therapist and Activity Characteristics on the Purposeful Responses of Probable Alzheimer's Disease Participants. Groene, II.[2019]

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]

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]

Music therapy (MT) has been shown to improve mood, reduce anxiety and depression, and enhance cognitive functions like autobiographical recall and verbal fluency in Alzheimer's disease (AD) patients, making it a beneficial intervention for managing symptoms.

Given that Alzheimer's disease can begin years before symptoms appear, music interventions may also help delay or slow down neurodegeneration in individuals at risk for AD, such as those with genetic predispositions or early cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The promise of music therapy for Alzheimer's disease: A review. Matziorinis, AM., Koelsch, S.[2022]

This study is evaluating the effects of music therapy on brain plasticity, mood, and cognition in 135 participants with mild Alzheimer's Disease or mild cognitive impairment over a 12-month period, using rigorous methods like MRI to measure outcomes.

The trial aims to provide high-quality evidence on the effectiveness of music therapy compared to physical activity and no intervention, addressing a significant gap in research regarding non-pharmacological treatments for Alzheimer's Disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the Alzheimer and music therapy study: An RCT to compare the efficacy of music therapy and physical activity on brain plasticity, depressive symptoms, and cognitive decline, in a population with and at risk for Alzheimer's disease. Flo, BK., Matziorinis, AM., Skouras, S., et al.[2022]

The online home-based music intervention (MI) for people living with dementia (PwD) and their caregivers has been well-received and effectively delivered across five countries, indicating its feasibility and acceptance.

MI, guided by music therapists, empowers caregivers to use music in daily routines, potentially enhancing the health and quality of life for both caregivers and PwD, while also fostering therapeutic change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The HOMESIDE Music Intervention: A Training Protocol for Family Carers of People Living with Dementia. Odell-Miller, H., Blauth, L., Bloska, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10579886/

Home-based music therapy for persons with dementia and ... Music therapy has been found to be an effective intervention for persons with dementia (PWD) and their primary caregivers (PC), ...

2. withpower.com withpower.com/trial/phase-cognitive-dysfunction-6-2019-1093b

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

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3463939/

Efficacy of Music Therapy in Treatment for the Patients with ... We report that music therapy is effective in the treatment of Alzheimer's disease. We found that the secretion of 17β-estradiol and testosterone, ...

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05520268

Efficacy of Music Therapy and Digital Music Rehabilitation ... This study evaluates the applicability and clinical efficacy of conventional music therapy and digital music rehabilitation for dementia in home ...

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00401-7/fulltext

Home-based family caregiver-delivered music and reading ... Music interventions provided by qualified therapists within residential aged care are effective at attenuating behavioural and psychological ...

6. alzheimers.gov alzheimers.gov/clinical-trials/home-based-music-therapy-mild-cognitive-impairment-and-alzheimers

Home-Based Music Therapy for Mild Cognitive Impairment ... In this one-year study, researchers will evaluate the effects of home-based music therapy for people with mild cognitive impairment or Alzheimer's disease.

7. researchgate.net researchgate.net/publication/369167379_The_Impact_of_Music_Therapy_on_Alzheimer's_Disease_Outcomes

The Impact of Music Therapy on Alzheimer's Disease ... The purpose of the study was to evaluate the adjunct effect of long-term and home-based MT in AD patients under pharmacological treatment. ... Article ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT02020356

NCT02020356 | Music Therapy in Alzheimer's Disease The study hypothesis is that music therapy may have a positive impact on patients with AD complicated by behavioral disorders by reducing the intensity of ...