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Completed

NCT Number: NCT07306065

University of Central Florida Music Study

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Florida

Orlando, Florida, 32827, United States

About this study

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:

  • 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.
  • Unclear mechanisms of action: It remains unknown whether music therapy modulates neurotransmitter levels (serotonin, dopamine) or pathological proteins (amyloid-beta, tau) associated with AD.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music intervention

Other

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

Primary outcomes

  1. Effect of music therapy in Alzheimer's patients by analyzing salivary exosomes

    Time frame: 6 months

    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.

Secondary outcomes

  1. Identifying therapeutic benefits by correlating changes in biomarkers

    Time frame: 6 months

    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.

  2. Identify differences in individual participant biomarkers

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 29, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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