Alzheimers DiseaseNCT07306065
University of Central Florida Music Study
A study testing Music intervention in people with Alzheimers Disease and Dementia, run by University of Central Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimers Disease, Dementia, Dementia Alzheimer Type
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 49 years and younger
- prisoners
- unable to understand English and provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Central Florida
Orlando, Florida, 32827
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Alzheimers Disease, Dementia, Dementia Alzheimer Type
- Being tested
- Music intervention
- Keywords
- Alzheimer s disease, music, dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
UCF music concert where the participants will listen to symphonic, classical music for 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | All participants in study will undergo music intervention. Receives: Other: Music intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start28 Aug 2025
- Primary completion8 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study intervention is music, which is being provided by a UCF music concert where the participants will listen to symphonic music.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kiminobu Sugaya, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306065
- Sponsor's protocol ID
- STUDY00007771
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Proof of Music Therapy's Impact on Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07306065
- Acronym / sponsor ID
- STUDY00007771
- Conditions
- Alzheimers Disease, Dementia, Dementia Alzheimer Type
- Keywords
- Alzheimer s disease, music, dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study intervention is music, which is being provided by a UCF music concert where the participants will listen to symphonic music.
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Other: Music interventionAll participants in study will undergo music intervention. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 50 years old or older.
- 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
Key exclusion criteria (3 listed)
- 49 years and younger
- prisoners
- unable to understand English and provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionUCF music concert where the participants will listen to symphonic, classical music for 1 hour. | Other | All participants |
Primary outcome
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.
2 secondary outcomes
Identifying therapeutic benefits by correlating changes in biomarkers
Time frame: 6 months
Identify differences in individual participant biomarkers
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kiminobu Sugaya, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Alzheimers Disease and Dementia, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of music therapy in Alzheimer's patients by analyzing salivary exosomes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.