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

Trial Summary

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 data supports the effectiveness of the treatment Virtual Music Therapy for Alzheimer's Disease?

Research shows that music therapy can improve feelings, emotions, and social engagement in people with Alzheimer's, and it may also reduce stress and improve mood. Studies suggest that music therapy is usable and enjoyable for Alzheimer's patients, fostering positive interactions and reminiscence. ^{1 2 3 4 5}

Is virtual music therapy safe for humans?

Music therapy, including virtual forms, is generally well-tolerated and safe for people with Alzheimer's disease, with benefits like improved mood and reduced anxiety. ^{1 4 5 6 7}

How is Virtual Music Therapy different from other treatments for Alzheimer's disease?

Virtual Music Therapy is unique because it leverages music's ability to stimulate cognitive functions and improve mood, while being delivered through a virtual platform that allows personalized music selection and interaction. This approach can enhance memory recall and emotional well-being without relying on medication, making it a promising non-drug intervention for Alzheimer's patients. ^{4 7 8 9 10}

What is the purpose of this trial?

This study is designed to assess the feasibility that individualized reminiscence-based virtual music therapy sessions can enhance autobiographical memory, mood, and cognition in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's Disease (AD). 60 patients with MCI or mild dementia due to AD will receive two 30 minutes reminiscence-targeted virtual music therapy interventions per week for 8 weeks (a total of 16 sessions). Participants' (or supported by the study partner) self-reported and measurable outcomes including cognitive, anxiety, quality of life, and autobiographical memory will be assessed before and after the 8-week course of treatment. Blood-oxygenation level-dependent (BOLD) in functional magnetic resonance imaging (fMRI) will also be also measured before and after the 8-week course of treatment.

Research Team

Alexander Pantelyat, MD

Principal Investigator

Department of Neurology, Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

References

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

Does Music Therapy Improve Anxiety and Depression in Alzheimer's Patients? [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. 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]

4. France pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2023]

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

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

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

The promise of music therapy for Alzheimer's disease: A review. [2022]

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

Persons with moderate Alzheimer's disease use simple technology aids to manage daily activities and leisure occupation. [2014]

9. Italy 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. [2018]

10. France 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)]. [2009]