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Behavioral Intervention

Music Therapy for Alzheimer's Disease (MELODY Trial)

N/A
Waitlist Available
Led By Jacobo Mintzer, MD, MBA
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Alzheimer's disease or other type of dementia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
Suffer from moderate to severe Alzheimer's disease as established by the study team using the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria for possible and probable Alzheimer's Disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 1 (day 14 +/- 3 days) and visit 2 (day 21 +/- 3 days)
Awards & highlights

MELODY Trial Summary

This trial is testing whether music can improve symptoms for people with Alzheimer's.

Who is the study for?
This trial is for people aged 55-90 with moderate to severe Alzheimer's, as confirmed by specific criteria and tests. They must be able to listen to music or sounds for at least 10 minutes and have a caregiver who can provide accurate information. Those with severe hearing loss, certain neuropsychiatric symptoms, or mobility issues (as shown by the TUG test) cannot join.Check my eligibility
What is being tested?
The study compares the effects of listening to preferred music versus nature sounds on patients with Alzheimer's disease. It aims to see which intervention better impacts overall mood and alertness in a randomized cross-over design where participants will experience both interventions.See study design
What are the potential side effects?
Since this trial involves non-invasive interventions like music and nature sounds, there are minimal expected side effects. However, individual responses may vary based on personal sensitivity to sound.

MELODY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Alzheimer's disease or another type of dementia.
Select...
I have been diagnosed with moderate to severe Alzheimer's disease.

MELODY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 1 (day 14 +/- 3 days) and visit 2 (day 21 +/- 3 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (day 14 +/- 3 days) and visit 2 (day 21 +/- 3 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC).
Secondary outcome measures
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)

MELODY Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Preferred Music - Visit 1, Nature Sounds - Visit 2Experimental Treatment2 Interventions
Group II: Nature Sounds - Visit 1, Preferred Music - Visit 2Placebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Preferred Music
2022
N/A
~10
Nature Sounds
2020
N/A
~140

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,380 Total Patients Enrolled
National Endowment for the Arts, United StatesFED
10 Previous Clinical Trials
1,961 Total Patients Enrolled
American Association of Retired PersonsUNKNOWN

Media Library

Preferred Music (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05309369 — N/A
Alzheimer's Disease Research Study Groups: Preferred Music - Visit 1, Nature Sounds - Visit 2, Nature Sounds - Visit 1, Preferred Music - Visit 2
Alzheimer's Disease Clinical Trial 2023: Preferred Music Highlights & Side Effects. Trial Name: NCT05309369 — N/A
Preferred Music (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05309369 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the minimum age requirement for this study under 40 years old?

"This clinical trial is only open to individuals aged 55-90. For those outside of this demographic, there are 34 studies for minors and 756 trials available for adults over 65 years old."

Answered by AI

How many study participants are being enrolled in this clinical research?

"Affirmative. Per the records on clinicaltrials.gov, this medical experiment is presently recruiting participants. The trial was first advertised on May 11th 2022 and revised most recently on May 16th 2022; it calls for 10 patients to be enrolled at one site."

Answered by AI

Who meets the criteria to be enrolled in this clinical experiment?

"This study is recruiting around 10 elderly individuals with dementia, aged 55 to 90 years old."

Answered by AI

Is the research team still seeking participants for this experiment?

"That is true. According to the clinicaltrials.gov platform, this research study began recruiting on May 11th 2022 and has since been augmented up until May 16th 2022; it requires 10 participants from one medical site for completion."

Answered by AI
~3 spots leftby Apr 2025