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Behavioural Intervention

Music Therapy for Severe Dementia (AMUSED Trial)

N/A

Waitlist Available

Led By Alaine E. Reschke-Hernandez, PhD

Research Sponsored by Alaine E Hernandez, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

65 years or older

Late-onset dementia diagnosis from a physician

Must not have

Co-occurring movement disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if a music therapy treatment called AMUSED can help older adults with severe dementia in care facilities. They want to know if the therapy is feasible, if it can improve behavioral symptoms

Who is the study for?

This trial is for older adults with severe dementia living in care facilities. They should be able to attend small group sessions and participate in activities. There are no specific inclusion or exclusion criteria provided, but typically participants must meet certain health conditions and not have factors that would prevent them from fully participating.

What is being tested?

The study tests if AMUSED, a music therapy involving live music, singing, and instruments can improve engagement and reduce behavioral symptoms compared to reading aloud about life stories. It's a pilot randomized trial where participants join twice-weekly sessions for 12 weeks to determine the feasibility of a full-scale trial.

What are the potential side effects?

Since this intervention involves non-medical treatments (music therapy and reading), side effects are minimal but may include potential emotional distress or fatigue during participation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I have been diagnosed with late-onset dementia by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a movement disorder alongside my main condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4-week follow up (week 16; 4 weeks after removal of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4-week follow up (week 16; 4 weeks after removal of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change from Baseline in Dementia Behavior at 12 Weeks

Secondary study objectives

Mean Change from Baseline in Cognition at 12 Weeks

Mean Change from Baseline in Cognition at 4-Week Follow-Up

Mean Change from Baseline in Dementia Behavior at 4 Weeks

+3 more

Other study objectives

Mean Change in Spontaneous Speech at Week 12

Mean Change in Spontaneous Speech at Week 4

Mean Change in Spontaneous Speech at Week 8

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Music TherapyExperimental Treatment1 Intervention

Live delivery of a music therapy protocol that is designed to be led by a board-certified music therapist (MT-BC). Activity blocks are identical to the reading arm: * T0 Baseline measures * Weeks 1-4: music therapy intervention * T1 measures (end of week 4) * Weeks 5-8: music therapy intervention * T2 measures (end of week 8) * Weeks 5-8: music therapy intervention * T3 measures (end of week 12) * T4 measures 4-week-follow-up (week 16)

Group II: Reading AloudActive Control1 Intervention

Live reading aloud of an age-appropriate book by a group leader to control for social attention and isolate the effects of music. Activity blocks are identical to the music therapy arm: * T0 Baseline measures * Weeks 1-4: music therapy intervention * T1 measures (end of week 4) * Weeks 5-8: music therapy intervention * T2 measures (end of week 8) * Weeks 5-8: music therapy intervention * T3 measures (end of week 12) * T4 measures 4-week-follow-up (week 16)

0 / 3Eligibility criteria met