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Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia

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ClinicalTrials.gov Identifier: NCT04282798
Recruitment Status : Withdrawn (COVID delay and subsequent unavailability of staff.)
First Posted : February 25, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This project will study the efficacy of a personalized receptive music intervention on neuropsychiatric symptoms and general cognitive function in patients with mild and moderate Alzheimer's disease (AD) by race.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: Personalized Music Intervention Not Applicable

Detailed Description:
Music interventions have become a popular treatment option to be used alongside medicinal treatment for many chronic conditions including Alzheimer's disease. Healthcare providers and researchers have found that when patients who have chronic conditions engage with music that is patients' preference or most familiar to patients, the patients display positive changes in mood regulation and thinking overall. The investigators are trying to understand to what extent these music interventions could be useful for patients with Alzheimer's disease and for which populations the intervention is more effective for. To do this, the investigators are looking to recruit participants with a diagnosis of Alzheimer's disease to complete a four (4) week personalized music intervention where patients listen to a one-hour playlist created from patients' described preferences and songs.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Experimental: Personalized Music Intervention
Participants will complete a series of questionnaires to identify participants' music preferences and participants' sensitivity to reward from musical engagement. The responses from the music preference questionnaires will be used to create a 1 hr playlist of songs by a member of the study team for the participant to be played daily for four weeks. After playlist is created and transmitted to MP3 device, participants will pick up the equipment and a compliance log will be given for the participant and participants' caregivers to confirm adherence to the protocol of daily listening. The platform will be Spotify, where the MP3 device given to participant at the start of the intervention will be preprogrammed with the participant's personal playlist on the platform. This trial is a supplementary treatment option for cognitive and neuropsychiatric assessments for AD, as such no alterations in the current treatment plans of any participant will be necessary.
Other: Personalized Music Intervention
Participants will complete a series of questionnaires to identify participants' music preferences and participants' sensitivity to reward from musical engagement. The responses from the music preference questionnaires will be used to create a 1 hr playlist of songs by a member of the study team for the participant to be played daily for four weeks. After playlist is created and transmitted to MP3 device, participants will pick up the equipment and a compliance log will be given for the participant and participants' caregivers to confirm adherence to the protocol of daily listening. The platform will be Spotify, where the MP3 device given to participant at the start of the intervention will be preprogrammed with the participant's personal playlist on the platform. This trial is a supplementary treatment option for cognitive and neuropsychiatric assessments for AD, as such no alterations in the current treatment plans of any participant will be necessary.




Primary Outcome Measures :
  1. Change in severity of neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) severity score [ Time Frame: Initial and final visit, four weeks apart ]
    Examining changes in the NPI-Q which is an informant-based interview that assesses 12 neuropsychiatric symptoms of the participant. The NPI-Q includes 12 neuropsychiatric domains. Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates the severity of the symptoms present on a 3-point scale where 1 is "mild" and 3 is "severe".

  2. Change in Montreal Cognitive Assessment (MoCA) score [ Time Frame: Initial and final visit, four weeks apart ]
    Examining changes in the MoCA which is a cognitive test for Alzheimer's disease. The MoCA assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation to time and place. MoCA total scores range between 0 and 30; 18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment and less than 10 = severe cognitive impairment.


Secondary Outcome Measures :
  1. Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score [ Time Frame: At the end of the study, up to 9 months ]
    The 20-item Barcelona Music Reward Questionnaire (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and NPI-Q totals scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test.

  2. Correlation between the BMRQ score and MoCA score [ Time Frame: At the end of the study, up to 9 months ]
    The 20-item BMRQ (administered at enrollment) assesses facets of the music and reward experiences with 5 factors: Musical Seeking, Emotion Evocation, Mood Regulation, Social Reward, and Sensory-Motor. Participants indicate the level of agreement with each statement by using a five-point scale ranging from ''fully disagree'' (1) to ''fully agree'' (5). BMRQ total scores range between 20 and 100. BMRQ total scores and MoCA total scores will be used to assess whether these variables correlate. The correlation will be completed via statistical analysis in a chi squared test.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of Alzheimer's disease
  • English speaking

Exclusion Criteria:

  • Deaf or hard of hearing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04282798


Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Paul Rosenberg, MD Johns Hopkins University
Study Director: Melissa K Eustache, BS Johns Hopkins University Kreiger School of Arts & Sciences
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04282798    
Other Study ID Numbers: IRB00231227
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders