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

Trial Summary

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 data supports the effectiveness of the treatment Live Music Session for Alzheimer's Disease?

Research suggests that music therapy can improve the quality of life for Alzheimer's patients by enhancing mood, self-expression, and social interaction. It may also help maintain cognitive functions and reduce the need for certain medications. ^{1 2 3 4 5}

Is live music therapy safe for people with Alzheimer's disease?

Research suggests that music therapy, including live music sessions, is generally safe for people with Alzheimer's disease. It may improve mood, reduce the need for certain medications, and enhance social interaction without harmful side effects. ^{1 2 6 7 8}

How does the Live Music Session treatment differ from other treatments for Alzheimer's disease?

Live Music Session treatment is unique because it uses live music to engage Alzheimer's patients, leveraging their preserved musical memories and emotions to enhance social and communication functions, unlike traditional treatments that may not focus on these aspects. ^{1 4 6 9 10}

What is the purpose of this trial?

This study aims to investigate the neurophysiological effects of live music on individuals with early Alzheimer's Disease (AD), dementia, and/or mild cognitive impairment (MCI) and their caregivers. Heart rate (HR), heart rate variability (HRV), and brain activity will be measured as participant-caregiver dyads listen to preferred and improvised music performed by professional musicians. Investigators will leverage various measurement techniques including, but not limited to, electroencephalography (EEG), behavioral, surveys, and physiological monitoring to study the impact of live music on anxiety in AD and inter-dyad synchrony.

Research Team

AZA Allsop, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of response-related music stimulation versus general music stimulation on positive participation of patients with Alzheimer's disease. [2018]

2. France pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Self-regulated music stimulation for persons with Alzheimer's disease: impact assessment and social validation. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A pilot usability study of MINWii, a music therapy game for demented patients. [2012]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and Demographic Factors Associated with the Cognitive and Emotional Efficacy of Regular Musical Activities in Dementia. [2022]

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

Tailored music listening intervention to reduce sleep disturbances in older adults with dementia: Research protocol. [2021]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Adjunct effect of music therapy on cognition in Alzheimer's disease in Taiwan: a pilot study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

[Music therapy and Alzheimer disease]. [2014]

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

Preservation of musical memory and engagement in healthy aging and Alzheimer's disease. [2019]