Effects of Personalized Music Listening in Advanced Alzheimer's

September 20, 2025 updated by: Emine Atıcı, Okan University

The Effects of Personalized Music Listening on Functional and Cognitive Status in Advanced-Stage Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
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)
Music
Experimental: Personalized music
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)
Music

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Mini-Mental State Examination (SMMSE)
Time Frame: baseline and 12 week later

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)
Time Frame: baseline and 12 week later

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)
Time Frame: baseline and 12 week later

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clock Drawing Test (CDT)
Time Frame: baseline and 12 week later

The Clock Drawing Test is an important tool for assessing cognitive parameters, specifically evaluating the ability to understand and plan, which are components of constructive praxis. The patient is asked to draw a clock, place the numbers on it, and mark the indicated time. It is scored on a scale of 6 points, with a score below 4 indicating impaired cognitive function.

The scoring is as follows:

Writing the number 12 in the correct position = 3 points Writing all 12 numbers = 1 point Drawing the hour and minute hands = 1 point Correctly marking the indicated time = 1 point. The Clock Drawing Test (CDT) is a simple neuropsychometric tool that can be easily applied to assess various neuropsychiatric functions. It was introduced by Critchley (1953) as an indicator of structural apraxia in the early 20th century. A Turkish norm and validity-reliability study of the CDT was conducted by Cangoz et al. in a population aged 50 and above.
baseline and 12 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2025

Primary Completion (Actual)

September 15, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 20, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013 (Nahrain Medical Research Collective (NMRC))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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