Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 9:06 AM
Study NCT ID:
NCT06765434
Status:
COMPLETED
Last Update Posted:
2025-09-23
First Post:
2025-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Personalized Music Listening in Advanced Alzheimer's
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-01-03', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Standardized Mini-Mental State Examination (SMMSE)', 'timeFrame': 'baseline and 12 week later', 'description': '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.\n\nThe 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.\n\nSample Questio'}, {'measure': 'Functional Independence Measure (FIM)', 'timeFrame': 'baseline and 12 week later', 'description': "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.\n\nThe 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."}, {'measure': 'Frontal Assessment Battery (FAB)', 'timeFrame': 'baseline and 12 week later', 'description': '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.\n\nThe FAB consists of 6 subtests:\n\nSimilarities (conceptualization) Word Fluency (mental flexibility) Motor Series (programming) Contradictory Instructions (sensitivity to interference) Action-Nonaction (inhibition control) Environmental Autonomy (capturing behavior)'}], 'secondaryOutcomes': [{'measure': 'Clock Drawing Test (CDT)', 'timeFrame': 'baseline and 12 week later', 'description': '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.\n\nThe scoring is as follows:\n\nWriting 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease, Late Onset', 'Cognitive Impairment']}, 'descriptionModule': {'briefSummary': "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.\n\nA 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.\n\nThis study aims to examine the effects of personalized music activities on functional and cognitive status in individuals with advanced-stage AD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 65 and over\n* 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)\n\nExclusion Criteria:\n\n* Patients with hearing impairments that could interfere with music listening\n* Individuals who have received music education and are able to play an instrument\n* Patients with a history of heart disease, hypertension, or diabetes will be excluded from the study."}, 'identificationModule': {'nctId': 'NCT06765434', 'briefTitle': "Effects of Personalized Music Listening in Advanced Alzheimer's", 'organization': {'class': 'OTHER', 'fullName': 'Okan University'}, 'officialTitle': "The Effects of Personalized Music Listening on Functional and Cognitive Status in Advanced-Stage Alzheimer's Disease", 'orgStudyIdInfo': {'id': '013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': "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.", 'interventionNames': ["Other: Music ( Dmitri Shostakovich's Jazz Waltz Suite)"]}, {'type': 'EXPERIMENTAL', 'label': 'Personalized music', 'description': "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.", 'interventionNames': ['Other: Music( Personalized music)']}], 'interventions': [{'name': "Music ( Dmitri Shostakovich's Jazz Waltz Suite)", 'type': 'OTHER', 'description': 'Music', 'armGroupLabels': ['Control']}, {'name': 'Music( Personalized music)', 'type': 'OTHER', 'description': 'Music', 'armGroupLabels': ['Personalized music']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Okan University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Okan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Emine Atıcı', 'investigatorAffiliation': 'Okan University'}}}}