Alzheimer Disease, Late OnsetNCT06765434
Effects of Personalized Music Listening in Advanced Alzheimer's
A study testing Music ( Dmitri Shostakovich's Jazz Waltz Suite) and Music( Personalized music) in people with Alzheimer Disease, Late Onset and Cognitive Impairment, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Alzheimer Disease, Late Onset, Cognitive Impairment
- What is being tested?
- Music ( Dmitri Shostakovich's Jazz Waltz Suite) and Music( Personalized music)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2025to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Music ( Dmitri Shostakovich's Jazz Waltz Suite), Music( Personalized music)
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music ( Dmitri Shostakovich's Jazz Waltz Suite)Other
Music
Music( Personalized music)Other
Music
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Music( Personalized music) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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)
Measured: baseline and 12 week later
Secondary outcomes (1)
Clock Drawing Test (CDT)
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.
Measured: baseline and 12 week later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start3 Mar 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Late OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Atıcı, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765434
- Sponsor's protocol ID
- 013
- Status last verified
- Sep 2025
- First submitted
- 3 Jan 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Personalized Music Listening on Functional and Cognitive Status in Advanced-Stage Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06765434
- Acronym / sponsor ID
- 013
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: Music ( Dmitri Shostakovich's Jazz Waltz Suite)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. |
| Personalized music | Experimental | Other: Music( 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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music ( Dmitri Shostakovich's Jazz Waltz Suite)Music | Other | Control |
| Music( Personalized music)Music | Other | Personalized music |
Primary outcome
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
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.
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)
1 secondary outcome
Clock Drawing Test (CDT)
Time frame: baseline and 12 week later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music ( Dmitri Shostakovich's Jazz Waltz Suite) and Music( Personalized music) in people with Alzheimer Disease, Late Onset and Cognitive Impairment, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized Mini-Mental State Examination (SMMSE) (time frame: baseline and 12 week later). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.