Alzheimer DiseaseNCT04282798
Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
A study testing Personalized Music Intervention in people with Alzheimer Disease, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Personalized Music Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Alzheimer's disease
- English speaking
Who cannot join
- Deaf or hard of hearing
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Personalized Music Intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Music InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Personalized Music Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: Initial and final visit, four weeks apart
Secondary outcomes (2)
Correlation between the Barcelona Music Reward Questionnaire (BMRQ) score and NPI-Q score
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.
Measured: At the end of the study, up to 9 months
Correlation between the BMRQ score and MoCA score
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.
Measured: At the end of the study, up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study startJun 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Why it stopped: COVID delay and subsequent unavailability of staff.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Rosenberg, MD, Principal investigator, Johns Hopkins UniversityMelissa K Eustache, BS, Study director, Johns Hopkins University Kreiger School of Arts & Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282798
- Sponsor's protocol ID
- IRB00231227
- Status last verified
- Jun 2020
- First submitted
- 21 Feb 2020
- Last updated
- 18 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Variation in Response to Music Interventions for People With Alzheimer's Dementia
- ClinicalTrials.gov ID
- NCT04282798
- Acronym / sponsor ID
- IRB00231227
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID delay and subsequent unavailability of staff.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized Music Intervention | Experimental | Other: Personalized Music InterventionParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Alzheimer's disease
- English speaking
Key exclusion criteria (1 listed)
- Deaf or hard of hearing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Music InterventionParticipants 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 |
Primary outcome
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".
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.
2 secondary outcomes
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
Correlation between the BMRQ score and MoCA score
Time frame: At the end of the study, up to 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Rosenberg, MD principal investigator
Johns Hopkins University
Melissa K Eustache, BS study director
Johns Hopkins University Kreiger School of Arts & Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Music Intervention in people with Alzheimer Disease, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.