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Can live music soothe severe dementia? new trial hopes to find out

NCT ID NCT06605157

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times

Summary

This pilot study tests a live music therapy program called AMUSED for older adults with severe dementia living in care facilities. Participants attend small group sessions twice a week for 12 weeks, either with music therapy or a reading activity. Researchers want to see if music therapy can improve engagement and reduce behavioral symptoms, and whether it is practical to run a larger trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
music therapy (AMUSED)
What this could lead to
If it works, this could point toward a non-drug way to help people with severe dementia feel more engaged and have fewer behavioral symptoms.
What could go wrong
This is a small pilot study with only 45 people, so results may not apply to everyone. It is testing feasibility, not yet proven effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

PARTICIPANT Inclusion Criteria: * 65 years or older * late-onset dementia diagnosis from a physician * stable at facility long enough to establish residency and routine at the facility (about 2 months prior to start of study) * English is primary language (for pilot study practicality and ensure straightforward evaluation of our aims) * Dementia is severe: As in the feasibility study, residents' charted score on the Brief Inventory of Mental Status (BIMS) \< 7 will be used and no independent function in community affairs, hobbies, chores, or personal care. The BIMS is a component of the Minimum Data Set (MDS), a federally mandated clinical assessment for all residents in US Medicare and Medicaid certified care facilities. It is completed periodically and interpreted by a licensed health care professional employed by the facility who has completed requisite training on the assessment. PARTICIPANT Exclusion criteria: * music therapy recipient * co-occurring movement disorder * preexisting cognitive disability * Milder dementia (BIMS 7+); Persons with more significant cognitive decline could arguably respond differently to the intervention than those with milder dementia, a notion that is supported by past music therapy research with this population. FACILITIES - Inclusion Criteria: * Any facility in Kentucky that provides residential care for persons with severe dementia (up to 8 facilities). * At least 5 residents must enroll to make the best use of our resources. * At least 1 facility staff member available to help with recruitment and periodic observable data collection * Can accommodate consistent session days and times between lunch and dinner, 2 times per week for 40 minutes, for 12 weeks. * Willing to communicate questions, concerns, and changes in safety protocols to the research team. * Can provide a space appropriate for a small group activity (3-5 residents plus a group leader). * Can ensure staff support is available for safely transitioning participants to/from sessions at the agreed upon session days and time. * Can assert that music therapy from a credentialed music therapist (MT-BC) is not offered by the facility, to prevent "double dosing" (music entertainment is ok). FACILITIES - Exclusion Criteria: -Does not meet one or more inclusion criteria.

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Conditions

The condition(s) this trial relates to.

Behavioral Symptoms dementia Language Speech

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cedar Ridge Health Campus

    Cynthiana, Kentucky, 41031, United States

  • Daisy Hill Senior Living

    Versailles, Kentucky, 40383, United States

  • Mayfair Manor

    Lexington, Kentucky, 40502, United States

  • Sayre Christian Village

    Lexington, Kentucky, 40517, United States

  • The Homeplace at Midway

    Midway, Kentucky, 40347, United States

  • Thomson-Hood Veterans Center

    Wilmore, Kentucky, 40390, United States

  • University of Kentucky

    Lexington, Kentucky, 40506, United States

  • Walker's Trail Senior Living

    Danville, Kentucky, 40422, United States

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