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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Alzheimer Disease; Music Therapy
• Intervention / Treatment: Behavioral: Preferred Music; Behavioral: Nature Sounds

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Long, MS; Phone Number: 843-792-5007; Email: longre@musc.edu
• Study Contact Backup: Name: Arianne Fritts, BS, MS; Phone Number: 843-670-1414; Email: kindya@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preferred Music - Visit 1, Nature Sounds - Visit 2	Behavioral: 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; 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
Placebo Comparator: Nature Sounds - Visit 1, Preferred Music - Visit 2	Behavioral: 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 informant and makes an informed judgment how to incorporate their input.	Visit 1 (Day 14 +/- 3 days) and Visit 2 (Day 21 +/- 3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)	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".	Visit 1 (Day 14 +/- 3 days) and Visit 2 (Day 21 +/- 3 days)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Endowment for the Arts, United States; American Association of Retired Persons
• Investigators: Principal Investigator: Jacobo Mintzer, MD, MBA, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer Disease; Music; Brain stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease
• Other Study ID Numbers: 00115303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will be part of the Alzheimer's Clinical Trials Consortium (ACTC). The study abides by the principles for sharing of research data as described in the NIH Public Access Policy on data sharing. The researchers endorse the sharing of final de-identified research data to serve important scientific goals. This project will facilitate sharing of software, archived study datasets (including images), assessment instruments, forms, and procedures through the web-based tools of the ACTC. The ACTC web portal will include access to inventories of resources and request procedures. All ACTC archival datasets will be included on the Global Alzheimer's Association Interactive Network (GAAIN); ACTC data can be accessed via the GAAIN platform; full or partial archived datasets can be shared via the dedicated ACTC Dataset- Sharing Portal.
• IPD Sharing Time Frame: It will become available one year after study recruitment it completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No