University of Central Florida Music Study

University of Central Florida

Status: Enrolling

Conditions: Dementia Alzheimer Type; Alzheimers Disease; Dementia

Treatments: Other: Music intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07306065

STUDY00007771

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

All participants

Experimental group

Description:

All participants in study will undergo music intervention.

Treatment:

Other: Music intervention