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

NCT04282798 | Withdrawn

• 1 other identifier: IRB00231227
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Change in severity of neuropsychiatric symptoms as assessed by the Neuropsychiatric Inventory-Questionnaire (NPI-Q) severity score

  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".

  Initial and final visit, four weeks apart

• Change in Montreal Cognitive Assessment (MoCA) score

  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.

  Initial and final visit, four weeks apart

Secondary Outcomes (2)

• Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score

  At the end of the study, up to 9 months

• Correlation between the BMRQ score and MoCA score

  At the end of the study, up to 9 months

Study Arms (1)

Personalized Music Intervention

EXPERIMENTAL

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

Interventions

Personalized Music Intervention OTHER

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.

Personalized Music Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Alzheimer's disease
• English speaking

You may not qualify if:

• Deaf or hard of hearing

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Paul Rosenberg, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Melissa K Eustache, BS

  Johns Hopkins University Kreiger School of Arts & Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 25, 2020
• Study Start: June 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: June 18, 2020

Record last verified: 2020-06