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

NCT ID: NCT05309369

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-11
• Study Completion Date: 2024-03-15

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.

Detailed Description

In partnership with the study partner (a person who spends 10 hours or more a week with the subject and can reliably report on the subject's condition), three tunes will be chosen for the purposes of the study. The tunes chosen will need to be related to a past meaningful, positive experience of the subject, as determined by the subject and the subject's study partner. The pieces will be restricted in duration to between 1.5 and 2 minutes each. A piece will be chosen at random and will be saved on a portable device, and subjects will be asked to listen to the melody using high quality, over-ear headphones. The total exposure time will be 10 minutes each hour over a three-hour period. The melody will be repeated as many times as necessary to complete the 10-minute period. The control intervention will involve listening to nature sounds at the same duration and administration scheme. Functional magnetic resonance imaging will be used to identify how brain networks are modulated via exposure to this music and how they associate with the clinical findings.

Conditions

Alzheimer Disease; Dementia; Music Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Preferred Music - Visit 1, Nature Sounds - Visit 2

Group Type: EXPERIMENTAL

Preferred Music

Intervention Type: 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

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Preferred Music

Intervention Type: 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

Intervention Type: 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

Interventions

Preferred Music

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

Intervention Type: BEHAVIORAL

Nature Sounds

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Endowment for the Arts, United States

FED

Sponsor Role: collaborator

American Association of Retired Persons

UNKNOWN

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacobo Mintzer, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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 May 24:100087. doi: 10.1016/j.inpsyc.2025.100087. Online ahead of print.

Reference Type: DERIVED

PMID: 40414740 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00115303

Identifier Type: -

Identifier Source: org_study_id