Effects of Personalized Music Listening in Advanced Alzheimer's

NCT06765434 | Completed

• 1 other identifier: 013
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Recent functional imaging studies have facilitated a better understanding of the neuroplasticity mechanisms underlying the strong and multifaceted effects of music on brain development. For this reason, music is considered a significant factor in improving recall and mood in individuals with dementia. A review investigating the cognitive and behavioral effects of music listening in Alzheimer's disease (AD) reported that personalized (individualized) music listening yielded the best outcomes. This study aims to examine the effects of personalized music activities on functional and cognitive status in individuals with advanced-stage AD.

Conditions

Alzheimer Disease, Late Onset; Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• Standardized Mini-Mental State Examination (SMMSE)

  First introduced in 1975 by Folstein and colleagues, this test is one of the most widely used tools for quantitatively assessing cognitive performance within standard europsychiatric examination methods. It was developed as a brief cognitive assessment tool. The test holds particular significance in evaluating elderly patients. Its validity and reliability have been confirmed in many countries. In Turkey, the validity and reliability study was conducted by Güngen and colleagues. Although it has limited specificity for distinguishing clinical syndromes, it is a short, practical, and standardized test suitable for assessing overall cognitive levels. The SMMSE evaluates cognitive functions across five domains: orientation, registration, attention and calculation, recall, and language. The total score is 30. Scores of 24 or below indicate the need for evaluation for dementia. The inter-rater reliability study reported an r-value of 0.99 and a kappa value of 0.92. Sample Questio

  baseline and 12 week later

• Functional Independence Measure (FIM)

  Developed by Hamilton et al. (1994), the scale measures the degree of independence in individuals' basic physical and cognitive functions in daily living activities. The FIM consists of 18 items and assesses two main domains: motor (13 items) and cognitive (5 items). The maximum scores for the Functional Independence Measure in motor (FIM-M) and cognitive (FIM-C) are 91 and 35, respectively. The total FIM score can range from 18 to 126. It includes six functional areas: self-care, sphincter control, mobility, locomotion, communication, and social perception. Each item is evaluated using a 7-point scale, and the total score is 126. The Turkish validity and reliability study for the scale was conducted by Küçükdeveci et al. in 2001. The internal consistency was found to be above 0.48 for individuals with spinal cord injuries and 0.44 for stroke patients.

  baseline and 12 week later

• Frontal Assessment Battery (FAB)

  The Frontal Assessment Battery, developed by Dubois et al., is a simple, easy-to-administer, and brief (approximately 10 minutes) bedside test designed to assess frontal lobe functions. It is useful in evaluating frontal lobe functions and detecting executive dysfunctions, as well as distinguishing degenerative diseases involving cortical-subcortical structures and monitoring the progression of these diseases. The FAB consists of 6 items, each scored on a 0-3 scale, with higher scores indicating better performance. The Turkish validity and reliability study was conducted by Güleç et al. (2009), and the internal consistency was found to be 0.65. The FAB consists of 6 subtests: Similarities (conceptualization) Word Fluency (mental flexibility) Motor Series (programming) Contradictory Instructions (sensitivity to interference) Action-Nonaction (inhibition control) Environmental Autonomy (capturing behavior)

  baseline and 12 week later

Secondary Outcomes (1)

• Clock Drawing Test (CDT)

  baseline and 12 week later

Study Arms (2)

Control

EXPERIMENTAL

The control group will listen to No. 2 from Dmitri Shostakovich's Jazz Waltz Suite played from a CD player for 12 weeks, 3 days per week.

Other: Music ( Dmitri Shostakovich's Jazz Waltz Suite)

Personalized music

EXPERIMENTAL

In the experimental group, music that has created positive impacts in the participants' lives will be identified and played from a CD player for 12 weeks, 3 days per week.

Other: Music( Personalized music)

Interventions

Music ( Dmitri Shostakovich's Jazz Waltz Suite) OTHER

Music

Control

Music( Personalized music) OTHER

Music

Personalized music

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Aged 65 and over
• Patients diagnosed with advanced-stage Alzheimer's type dementia according to the diagnostic criteria of the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-V)

You may not qualify if:

• Patients with hearing impairments that could interfere with music listening
• Individuals who have received music education and are able to play an instrument
• Patients with a history of heart disease, hypertension, or diabetes will be excluded from the study.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 9, 2025
• Study Start: March 3, 2025
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

TU (1)