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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in individuals with Alzheimer's disease and those who are cognitively healthy. CDIM is calming and does not rely on memory, potentially benefiting a wide range of people. The trial includes two groups: one with Alzheimer's patients experiencing anxiety and another with healthy individuals. Those with mild to moderate Alzheimer's and a history of anxiety may be suitable participants, provided they do not have hearing loss. As an unphased trial, this study offers a unique opportunity to explore innovative music therapy for anxiety relief.

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 prior data suggests that Clinically Designed Improvisatory Music is safe for Alzheimer's Disease patients and cognitively healthy individuals?

Research has shown that Clinically Designed Improvisatory Music (CDIM) is generally well-received. In one study, 429 healthcare providers participated in CDIM sessions, and 93% recommended it. This high recommendation rate suggests that participants find CDIM safe and valuable. Early results also indicate that CDIM can help reduce anxiety in people with Alzheimer's disease and their caregivers. These studies have reported no major negative effects. Although more detailed safety information is not yet available, the positive feedback and absence of reported issues suggest that CDIM is a safe treatment option. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using clinically designed improvisatory music for Alzheimer's disease because it offers a non-pharmacological approach that might enhance cognitive function and emotional well-being. Unlike standard treatments like medications that aim to manage symptoms, this approach uses music as a therapeutic tool, potentially providing a complementary or alternative option without the side effects of drugs. The unique aspect of this treatment lies in its ability to engage the brain in a dynamic way, possibly promoting neuroplasticity and improving mood, which is vital for quality of life in Alzheimer's patients.

What evidence suggests that Clinically Designed Improvisatory Music might be an effective treatment for anxiety in Alzheimer's Disease?

Research has shown that a special type of music therapy called Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people with Alzheimer's. In past studies, CDIM helped individuals feel more relaxed and less tense. Early results suggest that music therapy like CDIM can also positively affect thinking and memory skills. This therapy doesn't rely on personal memories, so it might work well for many different people. Overall, CDIM could offer a new way to help Alzheimer's patients feel calmer and more comfortable. Participants in this trial will receive CDIM to evaluate its effects on anxiety and cognitive function in both Alzheimer's patients and cognitively healthy individuals. ^{1 2 3 6 7}

Who Is on the Research Team?

Borna Bonakdarpour, MD, FAAN

Principal Investigator

Northwestern Mesulam Center for Cognitive Neurology and Alzheimer Disease

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05477862?tab=table

Neural Mechanisms of Clinically Designed Improvisatory Music ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

2. alz.confex.com alz.confex.com/alz/2025/meetingapp.cgi/Paper/104068

Clinical Improvisatory Music for Alzheimer's Disease Anxiety and ... Here we present preliminary data for ongoing trials exploring the feasibility of using Clinically Designed Improvisatory Music (CDIM), previously shown ...

3. withpower.com withpower.com/trial/early-phase-1-alzheimer-disease-7-2022-083d8

Improvised Music for Alzheimer's Disease What data supports the effectiveness of the treatment Clinically Designed Improvisatory Music for Alzheimer's Disease? Research shows that music therapy can ...

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000202678

Clinically Designed Improvisatory Music Interventions for ... The CDIM interventions resulted in improvements in tension, energy, and of pleasure, which suggest an increase in capacity. These preliminary results indicate ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10041788/

The effect of music therapy on cognitive functions in ... The results showed that compared to different control groups, there is an improvement in cognitive functions after music therapy application.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12542587/

effects of individual intensive musical training based on ... Still, there is a lack of rigorous studies examining whether musical semantic memory for newly learnt songs can be developed in patients with AD ...

7. brain.northwestern.edu brain.northwestern.edu/about/newsletter/2024-newsletter/a-melodic-therapy.html

A Melodic Therapy Preliminary results showed that administering Clinically Designed Improvisatory Music (CDIM) reduced anxiety levels in individuals with Alzheimer's and their ...