Live Music for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By AZA Lab

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Benzodiazepines

Disqualifiers: Suicidal ideation, Other AD trials, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 sessions, each lasting up to 3 hours

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of live music on individuals with early Alzheimer's, mild dementia, or mild cognitive impairment, along with their caregivers. Researchers will examine changes in heart rate, brain activity, and anxiety levels as participants listen to live music performed by professional musicians. The study will compare responses to live and pre-recorded music. Eligible participants include individuals with these conditions and their caregivers who are comfortable wearing monitoring devices and answering surveys. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance quality of life through music.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have started a new prescription medication in the last 6 months or if you are prescribed Benzodiazepines on an as-needed basis.

What prior data suggests that live music sessions are safe for individuals with Alzheimer's Disease and their caregivers?

Research has shown that music-based therapies can be safe and helpful for people with dementia. A review found that music interventions can reduce depression in these patients. Another study showed that music therapy improved mental health symptoms more than non-music therapies. While these studies highlight the benefits, they also indicate that music therapy is generally well-received.

Since music therapy doesn't involve drugs, it avoids typical medication side effects. Participants usually enjoy these sessions, making them a low-risk option for those involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using live music as a treatment for Alzheimer's disease because it offers a novel approach that differs from traditional medications aimed at managing symptoms. Unlike standard treatments, which often focus on chemical interventions to slow cognitive decline or manage behavioral symptoms, live music aims to positively impact emotional and social well-being. This treatment is unique because it leverages the power of music to potentially enhance social motivation, reduce anxiety, and even synchronize neural activity in a way that medications cannot. By tapping into these non-pharmacological effects, live music sessions could offer a complementary approach that enriches the lives of both patients and their caregivers.

What evidence suggests that live music sessions might be an effective treatment for Alzheimer's Disease?

This trial will evaluate the effects of live music sessions on individuals with Alzheimer's Disease and similar conditions. Research has shown that music therapy can help people with dementia think more clearly. Studies have found that music therapy not only boosts mental abilities but also reduces stress and depression in these patients. People with dementia often respond well to music, even if they have trouble speaking. Music therapy has been linked to a better quality of life and increased social interaction. Overall, evidence suggests music therapy can benefit individuals with Alzheimer's Disease and similar conditions. ^{3 4 6 7 8}

Who Is on the Research Team?

AZA Allsop, MD, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for early Alzheimer's patients and their caregivers. Participants should have a diagnosis of mild cognitive impairment, Alzheimer's Disease, or dementia. Caregivers can be foster parents or primary caregivers.

Inclusion Criteria

Able to provide informed consent

Willing to be audio / video recorded

Willing to wear an EEG headset and heart rate monitoring devices

Exclusion Criteria

Clinical Dementia Rating <0.5 or > 2

Endorsing suicidal ideation (SI), self-injurious behavior, or homicidal ideation (HI) above the threshold defined in the 'Risk Reduction and Safety Plan'

Participating in another clinical trial studying AD and/or Dementia

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants attend live music performances and pre-recorded control session performances. Physiological and survey data are collected to assess the impact of music on anxiety, social motivation, parasympathetic activity, and neural synchrony.

2 sessions, each lasting up to 3 hours

2 visits (in-person)

Follow-up

Participants are monitored for changes in neurophysiological measures and emotional well-being after the music sessions.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Live Music Session

Trial Overview

The study measures the impact of live music on heart rate, brain activity, and anxiety levels in patient-caregiver pairs using EEGs and other monitoring tools. It compares responses to live versus pre-recorded sessions with professional musicians.

How Is the Trial Designed?

Group I: AD / Dementia / MCI participants and caregivers dyads with music Experimental Treatment 2 Interventions

Each participant will take part in two sessions. Both sessions will last up to 3 hours. Participants will attend a series of live music performances and pre-recorded control session performances. Physiological and survey data will be collected to assess the impact of live versus pre-recorded music on anxiety, social motivation, parasympathetic activity, and neural synchrony.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Yale University School of Medicine, Department of Psychiatry

Collaborator

NeuroArts Blueprint Initiative

Collaborator

Renée Fleming Foundation

Collaborator

Howard University

Collaborator

Trials

44

Recruited

15,200+

Published Research Related to This Trial

In a study involving 11 patients with Alzheimer's disease, response-related music stimulation led to higher levels of positive participation, such as singing and smiling, in 6 out of the 11 patients compared to general music stimulation.

The findings suggest that incorporating active music response activities could be beneficial in daily programs for patients with Alzheimer's, particularly for enhancing engagement and emotional responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of response-related music stimulation versus general music stimulation on positive participation of patients with Alzheimer's disease. Lancioni, GE., Bosco, A., De Caro, MF., et al.[2018]

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]

The MINWii music therapy game was found to be usable by patients with mild to moderately severe Alzheimer's disease, demonstrating either instant mastery or a clear learning effect based on their cognitive abilities during a three-month study with 7 participants.

Patients reported high satisfaction with MINWii, indicating it promotes positive interactions with caregivers and stimulates reminiscence, suggesting potential benefits for quality of life in dementia care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot usability study of MINWii, a music therapy game for demented patients. Boulay, M., Benveniste, S., Boespflug, S., et al.[2012]

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]

Continuous verbal cueing during music activities significantly increased participation in exercise among clients with Alzheimer's disease, suggesting that easier tasks and ongoing guidance can enhance engagement.

Instrumental music during exercise led to greater participation compared to vocal music, indicating that the type of music can influence the effectiveness of physical activities for individuals with Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different methods for eliciting exercise-to-music for clients with Alzheimer's disease. Cevasco, AM., Grant, RE.[2019]

In a study involving 89 dementia patients and their caregivers, a 10-week music coaching intervention showed that singing improved working memory in patients with mild dementia and helped maintain executive function in younger patients.

Music listening supported general cognition and quality of life in patients with moderate dementia not caused by Alzheimer's disease, while both interventions reduced depression in patients with mild dementia and Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Demographic Factors Associated with the Cognitive and Emotional Efficacy of Regular Musical Activities in Dementia. Särkämö, T., Laitinen, S., Numminen, A., et al.[2022]

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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This study compares different music therapy (MT) experiences and their impact on memory and language in patients with Alzheimer's disease and Mild Cognitive ...