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

Primary Purpose

Alzheimer Disease, Dementia, Music Therapy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Preferred Music

Nature Sounds

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Dementia, Alzheimer Disease, Brain stimulation, Music

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Preferred Music - Visit 1, Nature Sounds - Visit 2

Nature Sounds - Visit 1, Preferred Music - Visit 2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".

Full Information

NCT ID

NCT05309369

First Posted

March 25, 2022

Last Updated

May 5, 2023

Sponsor

Medical University of South Carolina

Collaborators

National Endowment for the Arts, United States, American Association of Retired Persons

1. Study Identification

Unique Protocol Identification Number

NCT05309369

Brief Title

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

Acronym

MELODY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 11, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of South Carolina

Collaborators

National Endowment for the Arts, United States, American Association of Retired Persons

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease, Dementia, Music Therapy

Keywords

Dementia, Alzheimer Disease, Brain stimulation, Music

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Preferred Music - Visit 1, Nature Sounds - Visit 2

Arm Type

Experimental

Arm Title

Nature Sounds - Visit 1, Preferred Music - Visit 2

Arm Type

Placebo Comparator

Intervention Type

Behavioral

Intervention Name(s)

Preferred Music

Intervention Description

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

Intervention Name(s)

Nature Sounds

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca Long, MS

Phone

843-792-5007

longre@musc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Arianne Fritts, BS, MS

Phone

843-670-1414

kindya@musc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacobo Mintzer, MD, MBA

Organizational Affiliation

Medical University of South Carolina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca Long, MS

Phone

843-792-5007

longre@musc.edu

First Name & Middle Initial & Last Name & Degree

Arianne Fritts, BS, MS

Phone

843-670-1414

kindya@musc.edu

First Name & Middle Initial & Last Name & Degree

Jacobo Mintzer, MD, MBA

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

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

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