University of Central Florida Music Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dementia; Alzheimers Disease; Dementia Alzheimer Type
• Intervention / Treatment: Other: Music intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Britney-Ann Wray, BS, CTBS, CCRP; Phone Number: 4072668742; Email: britney-ann.wray@ucf.edu
• Study Contact Backup: Name: Amoy Fraser, PhD, CCRP, PMP; Phone Number: 14072668742; Email: Amoy.Fraser@UCF.edu

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32827
      • Recruiting
      • University of Central Florida
      • Contact: Amoy Fraser, PhD, CCRP, PMP; Phone Number: 4072668742; Email: Amoy.Fraser@UCF.edu
      • Contact: Britney-Ann Wray, BS, CCRP, CTBS; Phone Number: 4072668742; Email: britney-ann.wray@ucf.edu
      • Principal Investigator: Kiminobu Sugaya, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; All participants in study will undergo music intervention.	Other: Music intervention; UCF music concert where the participants will listen to symphonic, classical music for 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of music therapy in Alzheimer's patients by analyzing salivary exosomes	To 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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying therapeutic benefits by correlating changes in biomarkers	To 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.	6 months
Identify differences in individual participant biomarkers	To explore the potential for personalized music therapy by identifying individual differences in biomarker responses, which could guide tailored therapeutic interventions for optimal patient outcomes.	6 months

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Kiminobu Sugaya, PhD, University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: October 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: dementia; music; Alzheimer s disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: STUDY00007771

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No