University of Central Florida Music Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Alzheimers Disease Dementia Dementia Alzheimer Type

Keywords

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Alzheimer s disease music dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

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.

Study Groups

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All participants

All participants in study will undergo music intervention.

Group Type EXPERIMENTAL

Music intervention

Intervention Type OTHER

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

Interventions

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Music intervention

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiminobu Sugaya, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

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