MELODY: Musical Engagement of Brain Lobes in Alzheimer's Disease Patients Study

Sponsor
Medical University of South Carolina (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05309369
Collaborator
American Association of Retired Persons (Other), National Endowment for the Arts, United States (U.S. Fed)
10
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

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. 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Preferred Music
  • Behavioral: Nature Sounds
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Musical Engagement of Brain Lobes in Alzheimer's Disease Patients Study
Anticipated Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC). [Visit 1 (Day 14 +/- 3 days) and 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 informant and makes an informed judgment how to incorporate their input.

Secondary Outcome Measures

  1. Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS) [Visit 1 (Day 14 +/- 3 days) and 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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jacobo Mintzer, MD, MBA, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacobo Mintzer, MD, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT05309369
Other Study ID Numbers:
  • 00115303
First Posted:
Apr 4, 2022
Last Update Posted:
Apr 4, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jacobo Mintzer, MD, Professor, Medical University of South Carolina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022