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
Phase: NA
Conditions: Dementia, Music Therapy, Caregiver Burden of People With Dementia, Neuropsychiatric Symptom, Frailty, Aged (80 or More), Non-Pharmacological Interventions
Sponsor: Instituto Nacional de Geriatria, Mexico

  
 
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 
 
NCT number: not assigned 
 
Date of the document: September 24th 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
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Introduction 
​
The global population aged 60 and over is projected to continue growing, 
leading to an increased prevalence of health conditions common in this 
demographic (1, 2). Mexico is experiencing accelerated population aging, which 
presents the challenge of meeting the needs of these individuals in a shorter 
timeframe (3) (see Figure 1).  
​
Dementia is highly prevalent in the older adult population, with projections 
indicating approximately 150 million people will be living with the condition by 2050 
(4). In Mexico, the reported prevalence of dementia is 14% in women and 10% in 
men (5). 
​
While various types of dementia exist, Alzheimer's disease is currently the most 
common, followed by vascular dementia. A third type, known as mixed dementia, 
results from the simultaneous presentation of both (6). 
​
Dementias significantly impact both the mental health (see Figure 2) and 
physical health (see Figure 3) of affected individuals (4, 7-9). The negative impact 
extends beyond the individual, disrupting family dynamics due to the diverse 
clinical manifestations of these conditions and the extensive care needs of the 
person living with the disease (10). 
​
Despite significant advancements in dementia management in recent years 
(e.g., monoclonal antibodies for early-stage Alzheimer's disease), available 
treatments remain limited, and the prognosis for disease progression has changed 
little (11). Non-pharmacological treatments are part of the therapeutic arsenal for 
caring for these patients and have demonstrated their utility across various 
manifestations of the disease (see Figures 2 and 3) (8, 12). 
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​
These treatments undergo a rigorous methodological evaluation of their effects, 
adhering to guidelines regarding their characteristics. These guidelines typically 
encompass the components of the intervention, proposed mechanisms of action, 
and anticipated changes or outcomes (12). 
​
The use of various musical elements has shown a positive effect on individuals 
with dementia, ranging from promoting reminiscence for cognition to improving 
mood and providing physical health benefits (13-17). One strategy, 'Music for Life,' 
developed in the 1990s by Linda Rose, utilizes musical improvisation led by 
professional musicians to enhance the care of older adults with this condition (18, 
19). This program has demonstrated positive outcomes and was recently 
introduced in Mexico for adaptation by Maestro Israel Castillo Hernández. Although 
'Music for Life' has been in operation for over two decades, its reintroduction in 
Mexico aims to explore its effects on a broader range of outcomes than those 
described in previous studies.  
​
Given the information above, a crossover clinical trial is proposed to investigate 
the effects of this intervention on a range of physiological variables, cognitive tests, 
and biomarkers, among other outcomes, in older adults living with dementia and 
their caregivers. 
General Objective 
​
To determine the effect of a music intervention based on improvisation on the 
health status of older adults living with dementia. 
Specific Objectives 
1.​ Describe the effects of an improvisation-based music intervention on the 
mental health of older adults living with dementia. 
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2.​ Investigate the effects of an improvisation-based music intervention on the 
physical health of older adults living with dementia. 
3.​ Evaluate the effects of musical improvisation on the primary caregivers of 
older adults living with dementia. 
Hypothesis 
Older adults living with dementia who receive an improvisation-based music 
intervention will demonstrate improved cognitive and physical performance.  
Research Question 
​
What are the effects of an improvisation-based music intervention on the overall 
health status of older adults with dementia? 
Relevance of the Proposal 
​
Music has played a pivotal role in the care of older adults. Cognitive challenges 
have perhaps seen the most benefit from these types of interventions. However, 
the comprehensive impact of music on both mental and physical health remains 
largely unexplored. Previous research has not utilized highly precise measurement 
instruments to assess the effects on issues that are particularly burdensome for the 
health of older adults. Gaining clarity on the health impact across various levels of 
the individual, and including the impact on their environment, will not only improve 
the care of these older adults but also contribute to answering existing questions 
and posing new ones about the relationship between music and the mind. 
Methodology 
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A pilot study facilitated the formation of the initial research team. This will be 
followed by a randomized, blinded, crossover study design to test the effect on 
various health variables in older adults (see Figure 4). 
Patients with a history of memory complaints or a previous diagnosis of mild 
or moderate Alzheimer's, vascular, or mixed dementia, among other characteristics 
(see Table 1), will be invited to participate. Once selected (diagnosis will be 
screened or corroborated), they will be randomized (see Figure 4), and a baseline 
evaluation will be performed (see Table 2). The intervention will consist of two-hour 
sessions over eight weeks (see Table 3). At the end of the intervention, a 
post-intervention evaluation will be conducted, followed by a washout period. 
Subsequently, the second intervention cycle will be performed. Finally, an 
intention-to-treat analysis will be conducted using mixed-effects models. 
Expected Outcomes 
Evidence will be obtained regarding the effects on the physical and mental 
health of older adults suffering from dementia, allowing for the establishment of 
causal pathways and questions that lead to new protocols. Furthermore, having 
this data available for exploitation by young researchers would open new 
approaches to understanding the phenomenon. The results will enable the 
refinement of intervention processes and better focus on the activities performed to 
maximize the benefit obtained by the intervention subjects. Moreover, they will be 
useful for proposing broader strategies with an impact on a larger group. Finally, it 
is expected that this project will initiate a permanent line of research linking arts 
with the health of older adults. 
 
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