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Completed

NCT Number: NCT07542535

Music Effects on Dementia

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.

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Key information

Conditions

Dementia Aged (80 or More) Arterial Occlusive Diseases Arteriosclerosis Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Caregiver Burden Caregiver Burden of People With Dementia Central Nervous System Diseases Cerebrovascular Disorders Dementia, Vascular Frailty Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Music Therapy Nervous System Diseases Neurocognitive Disorders Neuropsychiatric Symptom Non-Pharmacological Interventions Pathologic Processes Pathological Conditions, Signs and Symptoms Stress, Psychological Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Nacional de Geriatria

Mexico City, 10200, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Therapy

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Caregiver burden

    Time frame: 8 weeks

    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.

  2. Frailty

    Time frame: 8 weeks

    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.

  3. Depression

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Geriatria, Mexico

Other Gov

Collaborators

  • National Polytechnic Institute, Mexico
  • Universidad La Salle, Mexico

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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