Improvised Music for Alzheimer's Disease

Overseen By Clara Takarabe, BA, CMP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Hearing loss, MMSE<15, CDR>2, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

30 Participants Needed

Trial Summary

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 trial coordinators or your doctor.

What data supports the effectiveness of the treatment Clinically Designed Improvisatory Music for Alzheimer's Disease?

Research shows that music therapy can improve mood, emotions, and social engagement in Alzheimer's patients, particularly those with moderate dementia. Additionally, music therapy has been found to reduce the need for tranquilizing medication and improve overall quality of life. ^{1 2 3 4 5}

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

Research on music therapy for Alzheimer's patients suggests it is generally safe and can improve mood, social interaction, and quality of life. Studies have shown positive effects without reporting any harmful side effects. ^{1 2 5 6 7}

How is the treatment 'Clinically Designed Improvisatory Music' different from other treatments for Alzheimer's disease?

This treatment is unique because it uses improvisational music to stimulate cognitive activities and improve quality of life, potentially reducing the need for tranquilizing medications and enhancing social interactions, unlike traditional drug therapies. ^{1 2 3 8 9}

What is the purpose of this trial?

Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. We wish to examine if CDIM decreases anxiety in 15 cognitively healthy individuals and 15 Alzheimer Disease patients with anxiety (AD-A).

Research Team

Borna Bonakdarpour, MD, FAAN

Principal Investigator

Northwestern Mesulam Center for Cognitive Neurology and Alzheimer Disease

Eligibility Criteria

This trial is for both cognitively healthy individuals and those with Alzheimer's Disease who experience anxiety. Participants must have a score greater than 8 on the Beck Anxiety Inventory (BAI), indicating some level of anxiety.

Inclusion Criteria

Cognitively healthy individuals

Cognitively healthy control participants evaluated through the Northwestern Mesulam Center with BAI > 8

I have Alzheimer's with some memory or thinking problems, get anxious or agitated, and can still do many daily tasks on my own.

Exclusion Criteria

I have hearing loss.

Individuals with mild to moderate Alzheimer's disease with MMSE < 15, CDR > 2

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Clinically Designed Improvisatory Music (CDIM) intervention to assess its impact on anxiety and neural mechanisms

3 years

Follow-up

Participants are monitored for changes in neuropsychiatric inventory, skin conductance, respiratory rate, systolic blood pressure, heart rate, and resting state functional connectivity

4 weeks

Treatment Details

Interventions

• Clinically Designed Improvisatory Music

Trial Overview The study tests Clinically Designed Improvisatory Music (CDIM) to see if it can reduce anxiety in people without cognitive issues and those with Alzheimer's Disease. The music used is improvised, calming, and doesn't depend on personal memories.

Participant Groups

Group I: Cognitively Healthy (CH) Experimental Treatment 1 Intervention

Group II: Alzheimer Disease (AD) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

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]

In a study involving 15 individuals with early to middle-stage Alzheimer's disease, specific musical instruments significantly influenced rhythmic accuracy, with the djembe being the most effective for eliciting responses, indicating its potential therapeutic value.

In a second experiment with 10 individuals in later stages of Alzheimer's, a cappella singing led to the highest participation rates (63%), suggesting that engaging activities like singing can enhance involvement in therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of musical instruments used by the therapist to elicit responses from individuals in various stages of Alzheimer's disease. Cevasco, AM., Grant, RE.[2019]

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]

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]

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]

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

Value of musical instruments used by the therapist to elicit responses from individuals in various stages of Alzheimer's disease. [2019]

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

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

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. England pubmed.ncbi.nlm.nih.gov

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

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Dual-Task-Based Music Therapy to Improve Executive Functioning of Elderly Patients with Early Stage Alzheimer's Disease: A Multiple Case Study. [2023]