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Music Effects on Dementia

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07542535
Enrollment
7
Registered
2026-04-21
Start date
2025-11-10
Completion date
2025-12-20
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aged (80 or More), Caregiver Burden of People With Dementia, Dementia, Frailty, Music Therapy, Neuropsychiatric Symptom, Non-Pharmacological Interventions

Keywords

Aged, Dementia, Alzheimer´s disease, Vascular dementia, Non pharmacological therapy, Music Therapy, Caregiver burden, Frailty

Brief 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. 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.

Interventions

OTHERMusic Therapy

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

Sponsors

Instituto Nacional de Geriatria, Mexico
Lead SponsorOTHER_GOV
Universidad La Salle, Mexico
CollaboratorOTHER
National Polytechnic Institute, Mexico
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Individuals currently participating in a similar intervention or received similar intervention within the past 6 months * Undergoing continous treatment for another health condition

Design outcomes

Primary

MeasureTime frameDescription
Neuropsychiatric symptoms8 weeksThis 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.

Secondary

MeasureTime frameDescription
Caregiver burden8 weeksThe 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.
Frailty8 weeksThe 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.
Depression8 weeksThis 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.

Countries

Mexico

Contacts

PRINCIPAL_INVESTIGATORMario U Perez

Instituto Nacional de Geriatria, Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026