A Multimodal Music Therapy Intervention for Engaging Persons With Severe Dementia

Study acronym: AMUSED
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Trial completed Show 5 more changesShow less
    • Enrollment target: estimated 45 to confirmed 42
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised at 1 of 8 sites
    • Publications revised (10)
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion date: Aug 15, 2026 to Aug 28, 2026
    • Study completion date: Sep 15, 2026 to Sep 21, 2026
    v8
  4. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from May 1, 2026 to Aug 15, 2026
    • Study completion pushed from Jun 30, 2026 to Sep 15, 2026
    • Study sites: 9 to 8
    v7
  5. Study sites: 2 to 9
    • Primary completion date: Dec 31, 2025 to May 1, 2026
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date changed from estimate of Feb 1, 2025 to Mar 12, 2025
    • Site contacts updated at 1 of 2 sites
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Primary completion date: Oct 31, 2025 to Dec 31, 2025
    • Start date: Jan 2025 to Feb 1, 2025
    v4
  3. Start date: Nov 2024 to Jan 2025v3
  4. Start date: Oct 1, 2024 to Nov 2024v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06605157
Lead Sponsor Alaine E Hernandez, PhD
Collaborators: National Institute on Aging (NIA)
Conditions
(from sponsor)		 Dementia Severe
Related terms Behavioral Symptoms, Language, Speech
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov