Active — Not RecruitingNot Applicable

A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia

United States45 participantsStarted 2025-03-12

Plain-language summary

The goal of this pilot randomized clinical trial is to learn if a music therapy treatment, called AMUSED, can improve engagement and reduce behavioral symptoms in older adults with severe dementia who live in care facilities. The main questions it aims to answer are: * Is it feasible to conduct a full-scale trial of AMUSED? * Can investigators identify the best outcome measures to assess impact on behavioral symptoms of dementia? * Does speech offer a useful indicator of treatment effectiveness? Researchers will compare a group-based music therapy treatment to a reading activity to learn if music therapy leads to greater improvements in behavioral symptoms and speech patterns. Participants will: * Participate in either music therapy (includes live music, singing, and rhythmic instrument playing) or a reading group with stories about life and nature and talk about memories. * Attend small group sessions twice a week for 12 weeks, with each session lasting 40 minutes between lunch and dinner. * Be observed and assessed for behavioral symptoms, cognition, and speech several times during treatment and at a 4-week follow-up.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

Does not meet one or more inclusion criteria.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean Change from Baseline in Dementia Behavior at 12 Weeks

Timeframe: Baseline, end of Week 12

Trial details

NCT IDNCT06605157

SponsorAlaine E Hernandez, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-15

View on ClinicalTrials.gov More Dementia Severe trials

Plain-language summary