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

NCT05309369 | Completed Results

• 1 other identifier: 00115303
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Dementia; Music Therapy

Keywords

Dementia; Alzheimer Disease; Brain stimulation; Music

Outcome Measures

Primary Outcomes (1)

• Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)

  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.

  Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)

Secondary Outcomes (1)

• Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)

  Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)

Study Arms (2)

Preferred Music - Visit 1, Nature Sounds - Visit 2

EXPERIMENTAL

Behavioral: Preferred Music; Behavioral: Nature Sounds

Nature Sounds - Visit 1, Preferred Music - Visit 2

PLACEBO COMPARATOR

Behavioral: Preferred Music; Behavioral: Nature Sounds

Interventions

Preferred Music BEHAVIORAL

Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours

Nature Sounds - Visit 1, Preferred Music - Visit 2; Preferred Music - Visit 1, Nature Sounds - Visit 2

Nature Sounds BEHAVIORAL

Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours

Nature Sounds - Visit 1, Preferred Music - Visit 2; Preferred Music - Visit 1, Nature Sounds - Visit 2

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Person of any sex/gender aged between 55 and 90
• Stated willingness to comply with all study procedures and availability for the duration of the study
• In the opinion of the investigator, has an informant able and willing to provide accurate information about the participant (may be paid or unpaid caregiver)
• 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
• 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)
• Mini Mental State Examination (MMSE) score of 5-20
• Subject is reported by the study partner to be able to listen to a minimum of 10 minutes of music and a sound in an uninterrupted manner.

You may not qualify if:

• Suffer from severe hearing impairment as reported by the informant
• Presence of neuropsychiatric symptoms of dementia as determined by clinical observation by the Principal Investigator, including history of agitation and/or combative behavior.
• Individuals who score ≥ 12 seconds on the Timed Up and Go (TUG) Test.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Endowment for the Arts, United States: collaborator
• American Association of Retired Persons: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Mintzer J, Long R, Fritts A, Joseph J, Nietert PJ, Calev N, Brawman-Mintzer O. Musical Engagement of brain LObes in Alzheimer's Disease patients study (MELODY): A randomized controlled trial. Int Psychogeriatr. 2025 Dec;37(6):100087. doi: 10.1016/j.inpsyc.2025.100087. Epub 2025 May 24.

  PMID: 40414740 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Professor
• Organization: Medical University of South Carolina

mintzerj@musc.edu

843 367 4260

Study Officials

• Jacobo Mintzer, MD, MBA

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: May 11, 2022
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: It will become available one year after study recruitment it completed.

Locations

US (1)