Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:47 PM
Study NCT ID:
NCT05309369
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2022-03-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mintzerj@musc.edu', 'phone': '843 367 4260', 'title': 'Professor', 'organization': 'Medical University of South Carolina'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '5 weeks', 'description': 'Adverse events were not separated by intervention because no events occurred during the administration of either the experimental or control conditions. All adverse events reported occurred outside of the study visits and were determined to be unrelated to the study interventions. These events were monitored and documented in accordance with protocol guidelines and were not associated with the auditory exposures.', 'eventGroups': [{'id': 'EG000', 'title': 'Preferred Music - Visit 1, Nature Sounds - Visit 2', 'description': 'Preferred Music Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours\n\nNature Sounds Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 3, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Nature Sounds - Visit 1, Preferred Music - Visit 2', 'description': 'Preferred Music Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours\n\nNature Sounds Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arm Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscle Strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preferred Music', 'description': 'Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}, {'id': 'OG001', 'title': 'Nature Sounds', 'description': 'Nature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}], 'classes': [{'title': 'Marked improvement - Rating 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate improvement - Rating 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Minimal improvement - Rating 1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No change - Rating 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Minimal worsening - Rating 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Moderate worsening - Rating 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Marked worsening - Rating 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Marked improvement - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Moderate improvement - Rating 2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Minimal Improvement - Rating 2', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Change - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Minimal worsening - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate worsening - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Marked worsening - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)', 'description': 'This is a 7-item score ranging from "markedly worse" to "markedly improved". It is assessed by the study clinician who interviews both participant and makes an informed judgment how to incorporate their input.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 10 participants were assessed after being exposed to preferred music (PM) and nature sounds (NS) and rated on the Clinical Global Impression of Change (CGIC).'}, {'type': 'SECONDARY', 'title': 'Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preferred Music', 'description': 'Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}, {'id': 'OG001', 'title': 'Nature Sounds', 'description': 'Nature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}], 'classes': [{'title': '1 - Feeling active, vital, alert, or wide awake - Rating 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '2 - Functioning at high levels, but not at peak - Rating 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3 - Awake, but relaxed; responsive, but not fully alert - Rating 1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4 - Somewhat foggy, let down - Rating 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '5 - Foggy; losing interest in staying awake; slowed down - Rating 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '7 - No longer fighting sleep; sleep onset soon - Rating 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'X - Asleep - Rating 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '1 - Feeling active, vital, alert, or wide awake - Rating 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '2 - Functioning at high levels, but not at peak - Rating 2', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '3 - Awake, but relaxed; responsive, but not fully alert - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '4 - Somewhat foggy, let down - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '5 - Foggy; losing interest in staying awake; slowed down - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '6 - Sleepy, woozy, fighting sleep; prefer to lie down - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '7 - No longer fighting sleep; sleep onset soon - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'X - Asleep - Rating 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)', 'description': 'Participants will provide a self-assessed scoring of their level of arousal on a scale of 1-7 ranging from "Feeling active, vital, alert, or wide awake" to "No longer fighting sleep, sleep onset soon; having dream-like thoughts".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All 10 participants were assessed after being exposed to preferred music (PM) and nature sounds (NS) and rated on the Stanford Sleepiness Scale (SSS).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preferred Music - Visit 1, Nature Sounds - Visit 2', 'description': 'Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours\n\nNature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}, {'id': 'FG001', 'title': 'Nature Sounds - Visit 1, Preferred Music - Visit 2', 'description': 'Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours\n\nNature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}], 'periods': [{'title': 'First Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The PI contacted physicians in the Charleston, South Carolina area to inform them about the study and request patient referrals of potential participants. Once a referral was made, the potential participant was contacted by the PI via telephone, the study was described, and if the participant and study partner expressed interest in the study, the study coordinator scheduled them for a Screening Visit.', 'preAssignmentDetails': 'No significant events in the study occured after participant enrollment and prior to assignment of participants to an arm or group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preferred Music - Visit 1, Nature Sounds - Visit 2', 'description': 'Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours\n\nNature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}, {'id': 'BG001', 'title': 'Nature Sounds - Visit 1, Preferred Music - Visit 2', 'description': 'Preferred Music: Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours\n\nNature Sounds: Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-21', 'size': 371461, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-21T14:28', 'hasProtocol': True}, {'date': '2021-12-21', 'size': 373120, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-03-29T11:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2022-03-25', 'resultsFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2022-03-25', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-18', 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Intervention Response as Evaluated by the Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)', 'description': 'This is a 7-item score ranging from "markedly worse" to "markedly improved". It is assessed by the study clinician who interviews both participant and makes an informed judgment how to incorporate their input.'}], 'secondaryOutcomes': [{'measure': 'Change in Level of Arousal as Evaluated by the Stanford Sleepiness Scale (SSS)', 'timeFrame': 'Visit 1 (Day 14 +/- 3 days), Visit 2 (Day 21 +/- 3 days)', 'description': 'Participants will provide a self-assessed scoring of their level of arousal on a scale of 1-7 ranging from "Feeling active, vital, alert, or wide awake" to "No longer fighting sleep, sleep onset soon; having dream-like thoughts".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Alzheimer Disease', 'Brain stimulation', 'Music'], 'conditions': ['Alzheimer Disease', 'Dementia', 'Music Therapy']}, 'referencesModule': {'references': [{'pmid': '40414740', 'type': 'DERIVED', 'citation': "Mintzer J, Long R, Fritts A, Joseph J, Nietert PJ, Calev N, Brawman-Mintzer O. Musical Engagement of brain LObes in Alzheimer's Disease patients study (MELODY): A randomized controlled trial. Int Psychogeriatr. 2025 May 24:100087. doi: 10.1016/j.inpsyc.2025.100087. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': "This is a randomized, cross-over study to measure global and clinical impact and level of arousal in subjects suffering from moderate to severe Alzheimer's disease when exposed to emotionally impactful music compared to control intervention.", 'detailedDescription': "In partnership with the study partner (a person who spends 10 hours or more a week with the subject and can reliably report on the subject's condition), three tunes will be chosen for the purposes of the study. The tunes chosen will need to be related to a past meaningful, positive experience of the subject, as determined by the subject and the subject's study partner. The pieces will be restricted in duration to between 1.5 and 2 minutes each. A piece will be chosen at random and will be saved on a portable device, and subjects will be asked to listen to the melody using high quality, over-ear headphones. The total exposure time will be 10 minutes each hour over a three-hour period. The melody will be repeated as many times as necessary to complete the 10-minute period. The control intervention will involve listening to nature sounds at the same duration and administration scheme. Functional magnetic resonance imaging will be used to identify how brain networks are modulated via exposure to this music and how they associate with the clinical findings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Person of any sex/gender aged between 55 and 90\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* In the opinion of the investigator, has an informant able and willing to provide accurate information about the participant (may be paid or unpaid caregiver)\n* Suffer from moderate to severe Alzheimer's disease as established by the study team using the National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's Criteria for possible and probable Alzheimer's Disease\n* Diagnosis of Alzheimer's disease or other type of dementia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)\n* Mini Mental State Examination (MMSE) score of 5-20\n* Subject is reported by the study partner to be able to listen to a minimum of 10 minutes of music and a sound in an uninterrupted manner.\n\nExclusion Criteria:\n\n* Suffer from severe hearing impairment as reported by the informant\n* Presence of neuropsychiatric symptoms of dementia as determined by clinical observation by the Principal Investigator, including history of agitation and/or combative behavior.\n* Individuals who score ≥ 12 seconds on the Timed Up and Go (TUG) Test."}, 'identificationModule': {'nctId': 'NCT05309369', 'acronym': 'MELODY', 'briefTitle': "Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY", 'organization': {'class': 'OTHER', 'fullName': 'Medical University of South Carolina'}, 'officialTitle': "Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY", 'orgStudyIdInfo': {'id': '00115303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preferred Music - Visit 1, Nature Sounds - Visit 2', 'interventionNames': ['Behavioral: Preferred Music', 'Behavioral: Nature Sounds']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nature Sounds - Visit 1, Preferred Music - Visit 2', 'interventionNames': ['Behavioral: Preferred Music', 'Behavioral: Nature Sounds']}], 'interventions': [{'name': 'Preferred Music', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to selected music using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours', 'armGroupLabels': ['Nature Sounds - Visit 1, Preferred Music - Visit 2', 'Preferred Music - Visit 1, Nature Sounds - Visit 2']}, {'name': 'Nature Sounds', 'type': 'BEHAVIORAL', 'description': 'Participants will listen to nature sounds using over-ear headphones delivered as 10-minute segments at the top of each hour over the course of 3 hours', 'armGroupLabels': ['Nature Sounds - Visit 1, Preferred Music - Visit 2', 'Preferred Music - Visit 1, Nature Sounds - Visit 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}], 'overallOfficials': [{'name': 'Jacobo Mintzer, MD, MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of South Carolina'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'It will become available one year after study recruitment it completed.', 'ipdSharing': 'YES', 'description': "This study will be part of the Alzheimer's Clinical Trials Consortium (ACTC). The study abides by the principles for sharing of research data as described in the NIH Public Access Policy on data sharing. The researchers endorse the sharing of final de-identified research data to serve important scientific goals. This project will facilitate sharing of software, archived study datasets (including images), assessment instruments, forms, and procedures through the web-based tools of the ACTC. The ACTC web portal will include access to inventories of resources and request procedures. All ACTC archival datasets will be included on the Global Alzheimer's Association Interactive Network (GAAIN); ACTC data can be accessed via the GAAIN platform; full or partial archived datasets can be shared via the dedicated ACTC Dataset- Sharing Portal."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Endowment for the Arts, United States', 'class': 'FED'}, {'name': 'American Association of Retired Persons', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}