DementiaNCT07542535
Music Effects on Dementia
A study testing Music Therapy in people with Dementia and Music Therapy, run by Instituto Nacional de Geriatria, Mexico at 1 site in Mexico.
Trial summary
Older adults constitute a population whose age-related physiological and cognitive changes predispose them to conditions that are less likely to occur in younger individuals. Dementia encompasses a group of health conditions that primarily affect this age group. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Music Therapy, Caregiver Burden of People With Dementia
- What is being tested?
- Music Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteMexico
- Study dates
- 10 Nov 2025to 20 Dec 2025
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older adults aged 60 years or older
- Positive screening result for Alzheimer´s disease, vascular dementia, or mixed dementia
- Prior diagnosis of dementia in a mild or moderate stage
- Individuals capable of performing minimal physical activity
- Complete vaccination schedule for COVID-19 and influenza
Who cannot join
- Individuals currently participating in a similar intervention or received similar intervention within the past 6 months
- Undergoing continous treatment for another health condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Active Musical Intervention on the Health of Older Adults Living With Dementia: the DeMúsica Study, a Cross-over Trial on a Non-pharmacological Intervention
Older adults constitute a population whose age-related physiological and cognitive changes predispose them to conditions that are less likely to occur in younger individuals. Dementia encompasses a group of health conditions that primarily affect this age group. These disorders commonly impair mental functions-particularly memory-but they also manifest through behavioral symptoms, such as irritability, and exert a significant impact not only on the affected individual but also on their immediate environment.
In this study, the investigators will implement a structured musical improvisation intervention led by four professional concert musicians. This approach, which has demonstrated effectiveness in other populations, aims to evaluate its effects on the mental and physical health of older adults living with dementia. Additionally, the intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia.
Previous studies have reported the effectiveness of such interventions, noting improvements in memory, behavioral symptoms, and even overall physical well-being. To date, no studies of this nature have been conducted in our country, making this the first to pursue an extensive exploration of outcomes-not only those traditionally assessed in similar trials, but also a broader evaluation of various dimensions of health in older adults undergoing the intervention. Additionally, caregivers may also benefit from actively participating in these sessions, which are designed to include them from the very beginning. Beyond generating data on the potential effects across different bodily and cognitive functions-knowledge that may become a leading reference in this field-this intervention holds the potential to be scaled up, thereby benefiting a larger population and ultimately enhancing the care provided to older adults living with dementia.
Read the detailed description
Older adults are a group of people whose age makes them prone to developing conditions they would not have if they were younger. Dementias are a group of health conditions that commonly occur in older adults. They are a group of conditions that affect, among other mental functions, memory; but they often present other behavioral manifestations (such as irritability) and impact not only the person suffering from them, but also those around them. In this study, the investigators will use musical improvisation led by four concert musicians through a structured intervention which has proven effective in other populations-to understand the effects on the mental and physical health of older adults with dementia; the investigators will also assess caregivers to determine whether this intervention has an impact beyond the person with dementia. There is evidence regarding the effectiveness of these treatments, with improvements observed in memory, behavioral symptoms, and even the person's overall physical condition. On the other hand, it will be the caregivers who may also benefit by actively participating in these sessions, which involve them from the very beginning.
- Conditions
- Dementia, Music Therapy, Caregiver Burden of People With Dementia, Neuropsychiatric Symptom, Frailty, Aged (80 or More)
- Being tested
- Music Therapy
- Keywords
- Aged, Dementia, Alzheimer´s disease, Vascular dementia, Non pharmacological therapy, Music Therapy, Caregiver burden, Frailty
- Medical subject headings
- Dementia, Frailty, Dementia, Vascular, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyOther
Each session lasts three hours and includes preparation and rehearsal, an introductory improvisation with musical instruments, improvisation by patients and their caregivers with small percussion instruments, and finally, an artistic reflection involving musicians, caregivers, and patients
| Study group | Role | What they receive |
|---|---|---|
| Music therapy in caregiver burden of dementia patients: A quasi-experimental study | Experimental | The intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia. Additionally, two other outcomes will be assessed as secondary goals: frailty and neuropsychiatric symptoms. Receives: Other: Music Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychiatric symptoms
This outcome was assessed with the Neuropsychiatric Inventory Questionnaire, has a score that ranges from 0 to 12, with the lowest score meaning no neuropsychiatric symptoms and 12 the highest neuropsychiatric symptom burden possible. Additionally, if the symptom is present, a severity scale is applied for the symptom, that ranges from 0 to 36.
Measured: 8 weeks
Secondary outcomes (3)
Caregiver burden
The caregiver burden was assessed with two instruments. The first one is the one linked to the NPI-Q, in which the caregiver is asked about the stress a particular symptom raises. This tool goes from a score 0 to 60, with zero the lowest stress possible and 60 the highest stress possible. Additionally, caregiver burden was also measured with the Scale of Caregiver Burden from Zarit \& Zarit, that goes from 22 to 110; 22 is the lowest score and burden possible while 110 the highest.
Measured: 8 weeks
Frailty
The Short Physical Performance Battery, this test explores three different tasks, gait speed, balance and endurance. Each one of the sub-tests has a maximum score of 4 and zero as the lowest possible. By adding up each subtest, the complete battery score ranges from 0 to 12; a cut-off point for frailty of 10 was used.
Measured: 8 weeks
Depression
This was measured with the Geriatríc Depression Scale of 15 items from Yesavage. The lowest score possible reflects a low burden of depression, while the highest could reflect clinical depression.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start10 Nov 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Model description
- This is a pre-experimental design, in which the participants will be exposed to the intervention and outcomes will be measured before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Geriatria, Mexico
- Sponsor type
- Other government
- Collaborators
- Universidad La Salle, Mexico, National Polytechnic Institute, Mexico
- Responsible party
- Principal investigator, Mario Ulises Perez Zepeda, Instituto Nacional de Geriatria, Mexico
- Investigators
- Mario U Perez, Principal investigator, Instituto Nacional de Geriatria, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542535
- Sponsor's protocol ID
- INGer
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the main analysis is finished, the data will be shared upon request to the main researcher.
Publications
Salihu D, Chutiyami M, Bello UM, Sulaiman SK, Dawa KK, Hepworth A, Adeleye KK, Alruwaili MM. A meta-review of systematic reviews on the effectiveness of music therapy on depression, stress, anxiety and cognitive function in adult's with dementia or cognitive impairment. Geriatr Nurs. 2024 Nov-Dec;60:348-360. doi: 10.1016/j.gerinurse.2024.09.014. Epub 2024 Oct 9.
PubMed 39388962Ting B, Chen DT, Hsu WT, Tsai CL, Malau IA, Lee SL, Jingling L. Multifaceted Music Therapy for Depression in Dementia: A Network Meta-Analysis of Randomized Controlled Trials. Eur J Investig Health Psychol Educ. 2024 Feb 11;14(2):351-367. doi: 10.3390/ejihpe14020024.
PubMed 38391491Ting B, Su CH, Chen DT, Hsu WT, Tsai CL, Lin PY, Jingling L. The Sound of Memory: Investigating Music Therapy's Cognitive Benefits in Patients with Dementia-A Network Meta-Analysis of Randomized Controlled Trials. J Pers Med. 2024 May 8;14(5):497. doi: 10.3390/jpm14050497.
PubMed 38793079Wong ARK, Ng LTE, Lee MH, Yeow JLH, Lim YJ, Yap KH. The effectiveness of group music reminiscence therapy for people thriving with dementia: A systematic review of randomized controlled trials. Aging Med (Milton). 2024 Aug 17;7(4):528-534. doi: 10.1002/agm2.12344. eCollection 2024 Aug.
PubMed 39234199Xu H, Li A, Apuke OD. The impact of group music therapy in ameliorating the depression among patients with dementia in care homes: A randomized control trial. Geriatr Nurs. 2024 Mar-Apr;56:304-311. doi: 10.1016/j.gerinurse.2024.02.021. Epub 2024 Feb 27.
PubMed 38417183Yuan SH, Silverman MJ, Cevasco-Trotter AM, Wang SG. Ten Reasons Why Neurologists Should Refer Patients With Alzheimer Dementia to Music Therapy. Neurol Clin Pract. 2024 Dec;14(6):e200357. doi: 10.1212/CPJ.0000000000200357. Epub 2024 Aug 16.
PubMed 39185103Borda MG, Landi F, Cederholm T, Venegas-Sanabria LC, Duque G, Wakabayashi H, Barreto GE, Rodriguez-Sanchez I, Canevelli M, Cano-Gutierrez C, Perez-Zepeda MU, Wallace L, Rockwood K, Salas-Carrillo M, Gjestsen M, Testad I, Ballard C, Aarsland D; IPEFUND. Assessment and management of frailty in individuals living with dementia: expert recommendations for clinical practice. Lancet Healthy Longev. 2025 Jan;6(1):100666. doi: 10.1016/j.lanhl.2024.100666. Epub 2024 Dec 27.
PubMed 39736268Mei Z, Zhang Y, Zhao W, Lam C, Luo S, Wang S, Luo S. Music-based interventions for anxiety and depression in older adults with dementia: A systematic review of randomized controlled trials. Complement Ther Clin Pract. 2025 May;59:101951. doi: 10.1016/j.ctcp.2025.101951. Epub 2025 Jan 13.
PubMed 39826392
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Active Musical Intervention on the Health of Older Adults Living With Dementia: the DeMúsica Study, a Cross-over Trial on a Non-pharmacological Intervention
- ClinicalTrials.gov ID
- NCT07542535
- Acronym / sponsor ID
- INGer
- Conditions
- Dementia, Music Therapy, Caregiver Burden of People With Dementia, Neuropsychiatric Symptom, Frailty, Aged (80 or More)
- Keywords
- Aged, Dementia, Alzheimer´s disease, Vascular dementia, Non pharmacological therapy, Music Therapy, Caregiver burden, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Instituto Nacional de Geriatria, MexicoOther government
- Collaborators
- Universidad La Salle, Mexico, National Polytechnic Institute, Mexico
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 21 Apr 2026 (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.
Older adults constitute a population whose age-related physiological and cognitive changes predispose them to conditions that are less likely to occur in younger individuals. Dementia encompasses a group of health conditions that primarily affect this age group. These disorders commonly impair mental functions-particularly memory-but they also manifest through behavioral symptoms, such as irritability, and exert a significant impact not only on the affected individual but also on their immediate environment.
In this study, the investigators will implement a structured musical improvisation intervention led by four professional concert musicians. This approach, which has demonstrated effectiveness in other populations, aims to evaluate its effects on the mental and physical health of older adults living with dementia. Additionally, the intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia.
Previous studies have reported the effectiveness of such interventions, noting improvements in memory, behavioral symptoms, and even overall physical well-being. To date, no studies of this nature have been conducted in our country, making this the first to pursue an extensive exploration of outcomes-not only those traditionally assessed in similar trials, but also a broader evaluation of various dimensions of health in older adults undergoing the intervention. Additionally, caregivers may also benefit from actively participating in these sessions, which are designed to include them from the very beginning. Beyond generating data on the potential effects across different bodily and cognitive functions-knowledge that may become a leading reference in this field-this intervention holds the potential to be scaled up, thereby benefiting a larger population and ultimately enhancing the care provided to older adults living with dementia.
Detailed description
Older adults are a group of people whose age makes them prone to developing conditions they would not have if they were younger. Dementias are a group of health conditions that commonly occur in older adults. They are a group of conditions that affect, among other mental functions, memory; but they often present other behavioral manifestations (such as irritability) and impact not only the person suffering from them, but also those around them. In this study, the investigators will use musical improvisation led by four concert musicians through a structured intervention which has proven effective in other populations-to understand the effects on the mental and physical health of older adults with dementia; the investigators will also assess caregivers to determine whether this intervention has an impact beyond the person with dementia. There is evidence regarding the effectiveness of these treatments, with improvements observed in memory, behavioral symptoms, and even the person's overall physical condition. On the other hand, it will be the caregivers who may also benefit by actively participating in these sessions, which involve them from the very beginning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre-experimental design, in which the participants will be exposed to the intervention and outcomes will be measured before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Music therapy in caregiver burden of dementia patients: A quasi-experimental study | Experimental | Other: Music TherapyThe intervention will be assessed in terms of its potential impact on primary caregivers, thereby exploring its reach beyond the individual diagnosed with dementia. Additionally, two other outcomes will be assessed as secondary goals: frailty and neuropsychiatric symptoms. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older adults aged 60 years or older
- Positive screening result for Alzheimer´s disease, vascular dementia, or mixed dementia
- Prior diagnosis of dementia in a mild or moderate stage
- Individuals capable of performing minimal physical activity
- Complete vaccination schedule for COVID-19 and influenza
Key exclusion criteria (2 listed)
- Individuals currently participating in a similar intervention or received similar intervention within the past 6 months
- Undergoing continous treatment for another health condition
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 |
|---|---|---|
| Music TherapyEach session lasts three hours and includes preparation and rehearsal, an introductory improvisation with musical instruments, improvisation by patients and their caregivers with small percussion instruments, and finally, an artistic reflection involving musicians, caregivers, and patients | Other | Music therapy in caregiver burden of dementia patients: A quasi-experimental study |
Primary outcome
Neuropsychiatric symptoms
Time frame: 8 weeks
This outcome was assessed with the Neuropsychiatric Inventory Questionnaire, has a score that ranges from 0 to 12, with the lowest score meaning no neuropsychiatric symptoms and 12 the highest neuropsychiatric symptom burden possible. Additionally, if the symptom is present, a severity scale is applied for the symptom, that ranges from 0 to 36.
3 secondary outcomes
Caregiver burden
Time frame: 8 weeks
Frailty
Time frame: 8 weeks
Depression
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 39388962Salihu D, Chutiyami M, Bello UM, Sulaiman SK, Dawa KK, Hepworth A, Adeleye KK, Alruwaili MM. A meta-review of systematic reviews on the effectiveness of music therapy on depression, stress, anxiety and cognitive function in adult's with dementia or cognitive impairment. Geriatr Nurs. 2024 Nov-Dec;60:348-360. doi: 10.1016/j.gerinurse.2024.09.014. Epub 2024 Oct 9.
- Background: PubMed 38391491Ting B, Chen DT, Hsu WT, Tsai CL, Malau IA, Lee SL, Jingling L. Multifaceted Music Therapy for Depression in Dementia: A Network Meta-Analysis of Randomized Controlled Trials. Eur J Investig Health Psychol Educ. 2024 Feb 11;14(2):351-367. doi: 10.3390/ejihpe14020024.
- Background: PubMed 38793079Ting B, Su CH, Chen DT, Hsu WT, Tsai CL, Lin PY, Jingling L. The Sound of Memory: Investigating Music Therapy's Cognitive Benefits in Patients with Dementia-A Network Meta-Analysis of Randomized Controlled Trials. J Pers Med. 2024 May 8;14(5):497. doi: 10.3390/jpm14050497.
- Background: PubMed 39234199Wong ARK, Ng LTE, Lee MH, Yeow JLH, Lim YJ, Yap KH. The effectiveness of group music reminiscence therapy for people thriving with dementia: A systematic review of randomized controlled trials. Aging Med (Milton). 2024 Aug 17;7(4):528-534. doi: 10.1002/agm2.12344. eCollection 2024 Aug.
- Background: PubMed 38417183Xu H, Li A, Apuke OD. The impact of group music therapy in ameliorating the depression among patients with dementia in care homes: A randomized control trial. Geriatr Nurs. 2024 Mar-Apr;56:304-311. doi: 10.1016/j.gerinurse.2024.02.021. Epub 2024 Feb 27.
- Background: PubMed 39185103Yuan SH, Silverman MJ, Cevasco-Trotter AM, Wang SG. Ten Reasons Why Neurologists Should Refer Patients With Alzheimer Dementia to Music Therapy. Neurol Clin Pract. 2024 Dec;14(6):e200357. doi: 10.1212/CPJ.0000000000200357. Epub 2024 Aug 16.
- Background: PubMed 39736268Borda MG, Landi F, Cederholm T, Venegas-Sanabria LC, Duque G, Wakabayashi H, Barreto GE, Rodriguez-Sanchez I, Canevelli M, Cano-Gutierrez C, Perez-Zepeda MU, Wallace L, Rockwood K, Salas-Carrillo M, Gjestsen M, Testad I, Ballard C, Aarsland D; IPEFUND. Assessment and management of frailty in individuals living with dementia: expert recommendations for clinical practice. Lancet Healthy Longev. 2025 Jan;6(1):100666. doi: 10.1016/j.lanhl.2024.100666. Epub 2024 Dec 27.
- Background: PubMed 39826392Mei Z, Zhang Y, Zhao W, Lam C, Luo S, Wang S, Luo S. Music-based interventions for anxiety and depression in older adults with dementia: A systematic review of randomized controlled trials. Complement Ther Clin Pract. 2025 May;59:101951. doi: 10.1016/j.ctcp.2025.101951. Epub 2025 Jan 13.
- Individual participant dataSharing planned: Yes. Once the main analysis is finished, the data will be shared upon request to the main researcher.
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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.
Mario U Perez principal investigator
Instituto Nacional de Geriatria, Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy in people with Dementia and Music Therapy, run by Instituto Nacional de Geriatria, Mexico at 1 site in Mexico.
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 5 inclusion and 2 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 21 Apr 2026. 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 Mexico. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Neuropsychiatric symptoms (time frame: 8 weeks). 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 NCT07542535, which also lists 8 linked publications.
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 21 Apr 2026.