NCT07306065

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

October 8, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Alzheimer s diseasemusicdementia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Identifying therapeutic benefits by correlating changes in biomarkers

    6 months

  • Identify differences in individual participant biomarkers

    6 months

Study Arms (1)

All participants

EXPERIMENTAL

All participants in study will undergo music intervention.

Other: Music intervention

Interventions

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

All participants

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older.
  • adults with no mild-cognitive impairment
  • adults with mild-cognitive impairment
  • 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

You may not qualify if:

  • years and younger
  • prisoners
  • unable to understand English and provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Florida

Orlando, Florida, 32827, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Kiminobu Sugaya, PhD

    University of Central Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amoy Fraser, PhD, CCRP, PMP

CONTACT

Britney-Ann Wray, BS, CTBS, CCRP

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
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.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The study intervention is music, which is being provided by a UCF music concert where the participants will listen to symphonic music.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2025

First Posted

December 29, 2025

Study Start

August 28, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations