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University of Central Florida Music Study

Scientific Proof of Music Therapy's Impact on Alzheimer's Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07306065
Enrollment
80
Registered
2025-12-29
Start date
2025-08-28
Completion date
2026-05-01
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimers Disease, Dementia, Dementia Alzheimer Type

Keywords

Alzheimer s disease, music, dementia

Brief summary

The purpose of this study is to scientifically validate the impact of music therapy on Alzheimer's disease (AD) by analyzing molecular biomarkers in salivary exosomes. Exosomes are extracellular vesicles that carry molecular signals from brain cells, providing a non-invasive method to assess physiological changes.

Detailed description

Music therapy has long been recognized as a beneficial intervention for individuals with Alzheimer's disease (AD), with evidence supporting improvements in mood, cognitive function, and behavioral symptoms. However, despite widespread clinical use, the biological mechanisms underlying these benefits remain poorly understood. Most studies on music therapy in AD have relied on behavioral observations and qualitative assessments, lacking objective, molecular-level validation. Recent advancements in exosome research have opened new possibilities for non-invasive biomarker analysis. Exosomes, small extracellular vesicles released by cells, carry molecular signatures that reflect physiological states, including neurochemical changes associated with AD. However, to date, no study has investigated whether music therapy induces measurable changes in exosome biomarkers related to AD pathology. Key gaps in current knowledge include: 1. Lack of molecular validation for music therapy: While clinical benefits have been reported, no study has demonstrated the neurochemical effects of music therapy on biomolecular markers. 2. Unclear mechanisms of action: It remains unknown whether music therapy modulates neurotransmitter levels (serotonin, dopamine) or pathological proteins (amyloid-beta, tau) associated with AD. 3. Absence of personalized treatment approaches: Without biomarker-based validation, music therapy is typically applied in a one-size-fits-all manner, rather than being tailored to individual neurochemical profiles. 4. Limited non-invasive monitoring tools: Current methods for assessing treatment efficacy rely on neuroimaging or invasive procedures, which are costly and impractical for routine clinical use. This study seeks to address these gaps by leveraging salivary exosomes as a novel, non-invasive platform to quantify molecular changes induced by music therapy in AD patients.

Interventions

OTHERMusic intervention

UCF music concert where the participants will listen to symphonic, classical music for 1 hour.

Sponsors

University of Central Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

All participants will undergo the same intervention. Each participant will be assigned a participant ID. All research data will be associated with the participant ID only and not with any of the participant's personal identifiers.

Intervention model description

The study intervention is music, which is being provided by a UCF music concert where the participants will listen to symphonic music.

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 50 years old or older. * 20 adults with no mild-cognitive impairment * 20 adults with mild-cognitive impairment * 20 adults with Alzheimer's disease/ dementia. * participant or the participant's legally authorized representative must be able to read or speak English and agree to comply with study procedures. * pregnant women may chose to participate

Exclusion criteria

* 49 years and younger * prisoners * unable to understand English and provide consent

Design outcomes

Primary

MeasureTime frameDescription
Effect of music therapy in Alzheimer's patients by analyzing salivary exosomes6 monthsTo determine the effect of music therapy on key neurochemical biomarkers in Alzheimer's patients by analyzing serotonin, dopamine, amyloid-beta, and tau protein levels in salivary exosomes before and after music therapy sessions.

Secondary

MeasureTime frameDescription
Identifying therapeutic benefits by correlating changes in biomarkers6 monthsTo establish a molecular basis for the therapeutic benefits of music therapy by correlating changes in biomarker levels with cognitive, emotional, and behavioral outcomes in AD patients.
Identify differences in individual participant biomarkers6 monthsTo explore the potential for personalized music therapy by identifying individual differences in biomarker responses, which could guide tailored therapeutic interventions for optimal patient outcomes.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKiminobu Sugaya, PhD

University of Central Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026