Virtual Music Therapy for Alzheimer's Disease

Overseen By Alexander Pantelyat, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Head trauma, Claustrophobia, Medical device, 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: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether virtual music therapy can improve memory, mood, and thinking skills in people with mild memory issues due to Alzheimer's Disease. Participants will engage in two 30-minute music sessions each week for eight weeks, all conducted online. The study examines changes in memory, anxiety, and quality of life, with some participants also undergoing brain scans. This trial suits those with mild memory problems linked to Alzheimer's who can participate in online sessions. As an unphased trial, it offers a unique opportunity to explore innovative therapy options that could enhance quality of life.

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

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

What prior data suggests that this virtual music therapy is safe for Alzheimer's patients?

Research has shown that music therapy is generally safe for people with Alzheimer's Disease. Studies suggest it can improve mood and memory without harmful side effects. One review found that music therapy helps with symptoms like anxiety and agitation. Another study noted that music therapy might help preserve musical memory, even when other memories fade. These findings indicate that participants in virtual music therapy sessions can expect a safe experience with no significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Virtual Music Therapy for Alzheimer's Disease is unique because it offers a non-drug approach that can be accessed conveniently at home through virtual sessions. Unlike traditional treatments that primarily involve medications like cholinesterase inhibitors or memantine, this therapy aims to engage patients through music, potentially enhancing mood and cognitive function. Researchers are excited about this treatment because it could provide a safe, enjoyable, and easily accessible way to support patients and caregivers, possibly improving quality of life without the side effects associated with many standard medications.

What evidence suggests that virtual music therapy is effective for Alzheimer's Disease?

Research has shown that virtual music therapy, which participants in this trial will receive, can benefit people with Alzheimer's Disease (AD). Studies have found that music therapy can slow memory loss, particularly in recalling personal experiences and events. It also appears to enhance the ability to think and move simultaneously, as well as skills needed for planning and focusing. Additionally, music therapy has been linked to reduced agitation and depression in people with dementia. Music seems to uniquely reach parts of the brain that remain active even when other areas are affected by Alzheimer's. ^{5 6 7 8 9}

Who Is on the Research Team?

Alexander Pantelyat, MD

Principal Investigator

Department of Neurology, Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults aged 18-89 with mild cognitive impairment or early Alzheimer's Disease, as indicated by specific scores on a cognitive assessment test (MoCA). It excludes those who've had significant head trauma, are claustrophobic to the extent that they can't undergo MRI scans, have medical devices or metal in their body that interfere with MRI technology.

Inclusion Criteria

My memory test score indicates mild cognitive issues or early Alzheimer's.

Exclusion Criteria

You have worked with metal in the past or have metal objects inside your body.

Medical device incompatible with MRI scanning (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm brain clip, inner ear implant)

You are claustrophobic and cannot tolerate being inside a MRI machine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive reminiscence-targeted virtual music therapy sessions twice a week for 8 weeks

8 weeks

16 virtual sessions

Follow-up

Participants are monitored for changes in cognitive, anxiety, quality of life, and autobiographical memory levels, as well as brain activation patterns using fMRI

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Music Therapy

Trial Overview The study tests if virtual music therapy sessions focused on reminiscence can improve memory, mood, and thinking abilities in patients. Participants will attend two sessions per week over eight weeks. Their self-reported feelings and objective measures of cognition will be evaluated before and after treatment using fMRI imaging.

How Is the Trial Designed?

Group I: Virtual Music Therapy Experimental Treatment 1 Intervention

Participants will attend two 30 minutes long virtual music therapy sessions per week for 8 weeks using Zoom.

Virtual Music Therapy is already approved in United States, European Union, China, Japan for the following indications:

Approved in United States as Music Therapy for:

• Alzheimer's Disease
• Mild Cognitive Impairment

Approved in European Union as Music Therapy for:

• Alzheimer's Disease
• Dementia

Approved in China as Music Therapy for:

• Alzheimer's Disease
• Cognitive Impairment

Approved in Japan as Music Therapy for:

• Alzheimer's Disease
• Dementia

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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]

A randomized clinical trial involving 32 residents with Alzheimer's disease and related dementias showed that a singing-based music therapy intervention significantly improved feelings, positive emotions, and social engagement compared to a non-music condition (verbal discussion).

The positive effects of music therapy were particularly notable in individuals with moderate dementia, suggesting that music interventions can enhance psychosocial well-being in this population and should be tailored to patient characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music Therapy Increases Social and Emotional Well-Being in Persons With Dementia: A Randomized Clinical Crossover Trial Comparing Singing to Verbal Discussion. Reschke-Hernández, AE., Gfeller, K., Oleson, J., et al.[2023]

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]

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]

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]

A short 60-minute music therapy session significantly reduced stress levels and improved emotional states in 25 patients with mild Alzheimer's disease, as indicated by lower salivary cortisol levels.

The therapy also led to significant decreases in anxiety and depression scores, suggesting that music therapy could be an effective complementary treatment for enhancing emotional well-being in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Music Therapy Improve Anxiety and Depression in Alzheimer's Patients? de la Rubia Ortí, JE., García-Pardo, MP., Iranzo, CC., et al.[2018]

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 two studies involving eight patients with moderate Alzheimer's disease, technology-aided programs using pictorial instructions and music selection significantly improved the patients' ability to perform daily activities and engage with music, with over 85% correct responses in activity tasks.

Patients demonstrated effective learning in both studies, as evidenced by psychology students rating their behavior during the program more positively than in control situations, highlighting the potential of these interventions for enhancing daily functioning in Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with moderate Alzheimer's disease use simple technology aids to manage daily activities and leisure occupation. Lancioni, GE., Singh, NN., O'Reilly, MF., et al.[2014]

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]

In a study involving 32 Alzheimer's disease patients, video-music therapy significantly improved the quality of life for those with mild to moderate cognitive impairment, as measured by the Quality of Life in Alzheimer's Disease Scale (QOL-AD).

Patients with severe cognitive impairment did not show any improvement, indicating that video-music therapy may be most effective for individuals in the earlier stages of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of video-music therapy on quality of life improvement in a group of patients with Alzheimer's disease: a pre-post study. Rubbi, I., Magnani, D., Naldoni, G., et al.[2018]

Citations

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Music therapy is a potential intervention for cognition of ... Many articles have demonstrated that MT can reduce cognitive decline especially in autobiographical and episodic memories, psychomotor speed, executive ...

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An individualized music listening program to reduce ... This project aimed to reduce agitation in patients with Alzheimer's disease and related dementias (ADRD) by implementing an individualized music listening ...

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How and why music therapy reduces distress ... A Cochrane review of music-based interventions for people with dementia reported moderate-quality evidence for reduction in depression and ...

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Music Therapy for Patients With Alzheimer's Disease This study is designed to assess the feasibility that individualized reminiscence-based virtual music therapy sessions can enhance autobiographical memory, ...

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Effects of a music therapy and music listening intervention ... The aim of the present study was to evaluate the effects of an individual music therapy intervention and an individual music listening intervention on ...