NCT05309369: MELODY

Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY

Completed NA Results posted Last updated 9 September 2025

What this trial tests

NA trial testing Preferred Music in Alzheimer Disease in 10 participants. Completed in 15 March 2024.

Timeline

11 May 2022

Primary endpoint
15 March 2024

15 March 2024

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	supportive care
Enrollment	10
Start date	11 May 2022
Primary completion	15 March 2024
Estimated completion	15 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Preferred Music
• Nature Sounds

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Dementia — all drugs for Dementia →
• Music Therapy — all drugs for Music Therapy →

Sponsor

Medical University of South Carolina

Who can join

Adults 55 to 90, any sex, with Alzheimer Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) Primary · Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)

This is a 7-item score ranging from "markedly worse" to "markedly improved". It is assessed by the study clinician who interviews both participant and makes an informed judgment how to incorporate their input.

Marked improvement - Rating 1

Group	Value	95% CI
Preferred Music	0
Nature Sounds	0

Moderate improvement - Rating 1

Group	Value	95% CI
Preferred Music	5
Nature Sounds	2

Minimal improvement - Rating 1

Group	Value	95% CI
Preferred Music	2
Nature Sounds	0

No change - Rating 1

Group	Value	95% CI
Preferred Music	1
Nature Sounds	4

Minimal worsening - Rating 1

Group	Value	95% CI
Preferred Music	1
Nature Sounds	1

Moderate worsening - Rating 1

Group	Value	95% CI
Preferred Music	1
Nature Sounds	3

Marked worsening - Rating 1

Group	Value	95% CI
Preferred Music	0
Nature Sounds	0

Marked improvement - Rating 2

Group	Value	95% CI
Preferred Music	0
Nature Sounds	0

Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) Secondary · Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)

Participants will provide a self-assessed scoring of their level of arousal on a scale of 1-7 ranging from "Feeling active, vital, alert, or wide awake" to "No longer fighting sleep, sleep onset soon; having dream-like thoughts".

1 - Feeling active, vital, alert, or wide awake - Rating 1

Group	Value	95% CI
Preferred Music	3
Nature Sounds	1

2 - Functioning at high levels, but not at peak - Rating 1

Group	Value	95% CI
Preferred Music	1
Nature Sounds	4

3 - Awake, but relaxed; responsive, but not fully alert - Rating 1

Group	Value	95% CI
Preferred Music	5
Nature Sounds	2

4 - Somewhat foggy, let down - Rating 1

Group	Value	95% CI
Preferred Music	0
Nature Sounds	2

5 - Foggy; losing interest in staying awake; slowed down - Rating 1

Group	Value	95% CI
Preferred Music	1
Nature Sounds	1

6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 1

Group	Value	95% CI
Preferred Music	0
Nature Sounds	0

7 - No longer fighting sleep; sleep onset soon - Rating 1

Group	Value	95% CI
Preferred Music	0
Nature Sounds	0

X - Asleep - Rating 1

Group	Value	95% CI
Preferred Music	0
Nature Sounds	0

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Preferred Music - Visit 1, Nature Sounds - Visit 2

Serious: 0/5 (0%)

Deaths: 0/5

Nature Sounds - Visit 1, Preferred Music - Visit 2

Serious: 0/5 (0%)

Deaths: 0/5

Other adverse events (4 terms — click to expand)

Reaction	System	Preferred Music - Visit 1,…	Nature Sounds - Visit 1, P…
Fall	General disorders	—	—
Arm Abrasion	General disorders	—	—
Muscle Strain	General disorders	—	—
Common cold	General disorders	—	—

Data from ClinicalTrials.gov NCT05309369 adverse events section.

Sponsor's own description

This is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe Alzheimer's disease when exposed to emotionally impactful music compared to control intervention.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Proteostasis failure exacerbates neuronal circuit dysfunction and sleep impairments in Alzheimer's disease.
   Morrone CD, Raghuraman R, Hussaini SA, Yu WH. · · 2023 · cited 40× · PMID 37085942 · DOI 10.1186/s13024-023-00617-4
2. Musical Engagement of brain LObes in Alzheimer's Disease patients study (MELODY): A randomized controlled trial.
   Mintzer J, Long R, Fritts A, Joseph J, et al · · 2025 · cited 1× · PMID 40414740 · DOI 10.1016/j.inpsyc.2025.100087