Alzheimer DiseaseMELODYNCT05309369
Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY
A study testing Preferred Music and Nature Sounds in people with Alzheimer Disease and Dementia, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Music Therapy
- What is being tested?
- Preferred Music and Nature Sounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Music Therapy
- Being tested
- Preferred Music, Nature Sounds
- Keywords
- Dementia, Alzheimer Disease, Brain stimulation, Music
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preferred MusicBehavioural
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
Nature SoundsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Preferred Music - Visit 1, Nature Sounds - Visit 2 | Experimental | Not described Receives: Behavioral: Preferred Music; Behavioral: Nature Sounds |
| Nature Sounds - Visit 1, Preferred Music - Visit 2 | Placebo comparator | Not described Receives: Behavioral: Preferred Music; Behavioral: Nature Sounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 makes an informed judgment how to incorporate their input.
Measured: Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)
Secondary outcomes (1)
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".
Measured: Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start11 May 2022
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Endowment for the Arts, United States, American Association of Retired Persons
- Responsible party
- Sponsor
- Investigators
- Jacobo Mintzer, MD, MBA, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309369
- Sponsor's protocol ID
- 00115303
- Acronym
- MELODY
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2022
- Last updated
- 9 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Mintzer J, Long R, Fritts A, Joseph J, Nietert PJ, Calev N, Brawman-Mintzer O. Musical Engagement of brain LObes in Alzheimer's Disease patients study (MELODY): A randomized controlled trial. Int Psychogeriatr. 2025 Dec;37(6):100087. doi: 10.1016/j.inpsyc.2025.100087. Epub 2025 May 24.
PubMed 40414740
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY
- ClinicalTrials.gov ID
- NCT05309369
- Acronym / sponsor ID
- MELODY / 00115303
- Conditions
- Alzheimer Disease, Dementia, Music Therapy
- Keywords
- Dementia, Alzheimer Disease, Brain stimulation, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Endowment for the Arts, United States, American Association of Retired Persons
- Study start
- 11 May 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preferred Music - Visit 1, Nature Sounds - Visit 2 | Experimental | Behavioral: Preferred Music, Behavioral: Nature Sounds |
| Nature Sounds - Visit 1, Preferred Music - Visit 2 | Placebo comparator | Behavioral: Preferred Music, Behavioral: Nature Sounds |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Preferred MusicParticipants 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 | Behavioural | Nature Sounds - Visit 1, Preferred Music - Visit 2, Preferred Music - Visit 1, Nature Sounds - Visit 2 |
| Nature SoundsParticipants 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 | Behavioural | Nature Sounds - Visit 1, Preferred Music - Visit 2, Preferred Music - Visit 1, Nature Sounds - Visit 2 |
Primary outcome
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)
Time frame: Visit 1 (Day 14 +/- 3 days), 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 makes an informed judgment how to incorporate their input.
1 secondary outcome
Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)
Time frame: Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40414740Mintzer J, Long R, Fritts A, Joseph J, Nietert PJ, Calev N, Brawman-Mintzer O. Musical Engagement of brain LObes in Alzheimer's Disease patients study (MELODY): A randomized controlled trial. Int Psychogeriatr. 2025 Dec;37(6):100087. doi: 10.1016/j.inpsyc.2025.100087. Epub 2025 May 24.
- Individual participant dataSharing planned: Yes. 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.
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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.
Jacobo Mintzer, MD, MBA principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preferred Music and Nature Sounds in people with Alzheimer Disease and Dementia, run by Medical University of South Carolina at 1 site in United States.
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 8 inclusion and 3 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: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC) (time frame: Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05309369, which also lists 1 linked publication.
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 9 Sep 2025.