Music Effects on Dementia

NCT07542535 | Completed DMC

• 1 other identifier: INGer
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (3)

• Caregiver burden

  8 weeks

• Frailty

  8 weeks

• Depression

  8 weeks

Study Arms (1)

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.

Other: Music Therapy

Interventions

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

Music therapy in caregiver burden of dementia patients: A quasi-experimental study

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Geriatria, Mexico: lead
• Universidad La Salle, Mexico: collaborator
• National Polytechnic Institute, Mexico: collaborator

Study Sites (1)

Instituto Nacional de Geriatria

Mexico City, Mexico City, 10200, Mexico

Location

Related Publications (8)

• 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.

  PMID: 39388962 BACKGROUND

• Ting 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.

  PMID: 38391491 BACKGROUND

• Ting 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.

  PMID: 38793079 BACKGROUND

• Wong 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.

  PMID: 39234199 BACKGROUND

• Xu 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.

  PMID: 38417183 BACKGROUND

• Yuan 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.

  PMID: 39185103 BACKGROUND

• Borda 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.

  PMID: 39736268 BACKGROUND

• Mei 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.

  PMID: 39826392 BACKGROUND

MeSH Terms

Conditions

Dementia; Frailty; Dementia, Vascular; Caregiver Burden

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Mario U Perez

  Instituto Nacional de Geriatria, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Model Details: 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.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: April 21, 2026
• Study Start: November 10, 2025
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be stored and available for five years after the final analysis of the main objective.
• Access Criteria: A brief proposal on the secondary analysis, one page will be needed, with a current academic affiliation. It can be used for undergraduate thesis.

Locations

ME (1)