Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-01 @ 7:01 AM
Study NCT ID:
NCT04132193
Status:
UNKNOWN
Last Update Posted:
2019-10-25
First Post:
2019-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Processing of Music in Alzheimer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2019-10-08', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montreal Battery of Evaluation of Amusia', 'timeFrame': '60 minutes', 'description': 'Number of correct answers in three task collections (total 79 tasks)'}, {'measure': 'Brain atrophy in MRI scans', 'timeFrame': '120 minutes', 'description': 'Loss of volume in brain regions relevant for music processing and in the hippocampi estimated by voxel-based morphometry'}, {'measure': 'CERAD (Consortium for Establishing Registry of Alzheimer´s Disease)', 'timeFrame': '30 minutes', 'description': 'Level of cognitive impairment'}], 'secondaryOutcomes': [{'measure': 'Use of music in patient´s daily life', 'timeFrame': '30 minutes', 'description': 'Validated self-report questionnaire MusEQ in Finnish, Likert scale 1-5 (Vanstone AD et al, Aging Ment Health 2016)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Dementia', 'Amusia']}, 'descriptionModule': {'briefSummary': 'Correlation of musicality, brain atrophy in brain areas relevant for music processing and the stage of Alzheimer´s disease.', 'detailedDescription': "Alzheimer's disease (AD) is the most common cause of dementia accounting for 60-70% of all dementias. In most cases the cause for AD is unknown. The progression of AD is characterized by an advancing decline in cognitive skills and symptoms like impaired learning, memory deficits, language impairment and behavioral disturbances in later stages. The symptoms of AD are caused by cerebral atrophy which is the consequence of multiple pathological processes, including the formation of neurofibrillary tangles at neurites and amyloid plaques in the walls of cerebral blood vessels. AD is a major public health issue and its significance increases as the population grows older.\n\nMusic is thought to have preceded the development of spoken language as a form of communication and it has been used for therapeutic purposes in many ways throughout history. In patients with AD, musical memory has been noticed to be well-preserved and constituting a relatively independent part of memory. Music-based neurological rehabilitation provides a mode of treatment, which is free of side effects and can be personalized for patients with dementia.\n\nAims of this study are to examine how AD affects the structure of various brain areas associated with music processing and to statistically correlate musical cognition with memory performance in patients with AD. Focus is on brain areas associated with musical pleasure like the striatum, superior temporal gyrus, inferior frontal gyrus and areas associated with long-term musical memory like the anterior cingulate gyrus and presupplementary motor area. Hippocampal atrophy serves as a reference of the stage of AD. Our working hypothesis is that musicality correlates with preserved cognitive skills and memory.\n\nVoluntary participants who have been diagnosed with AD are recruited from Turku University Central Hospital. Their musicality is assessed with a short version of Montreal Battery of Evaluation of Amusia which contains listening tasks that test the patients' memory, rhythm recognition and pitch discrimination. In addition, patients are asked to fill an inquiry that maps their use of music and its significance in their daily lives. Voxel-Based Morphometry is applied on MRI images to evaluate atrophy in the hippocampus and entorhinal cortex, which correlate with clinical stages of AD, as well as on the brain areas relevant for processing of music."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of Southwest Finland Hospital District', 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosed Alzheimer´s disease\n\nExclusion Criteria:\n\nOther neurological comorbidity, substance abuse'}, 'identificationModule': {'nctId': 'NCT04132193', 'acronym': 'MUKU-DEM', 'briefTitle': 'Processing of Music in Alzheimer Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Correlation of Musicality and Cognitive Skills in Persons With Alzheimer´s Disease', 'orgStudyIdInfo': {'id': 'T112/2019'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Seppo Soinila, MD PhD', 'role': 'CONTACT', 'email': 'seppo.soinila@tyks.fi', 'phone': '+358503463396'}, {'name': 'Pavel Zaitsev, B.Sc.', 'role': 'CONTACT', 'email': 'pavel.p.zaitsev@utu.fi'}], 'overallOfficials': [{'name': 'Seppo Soinila, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Turku', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor, chief physician', 'investigatorFullName': 'Seppo Soinila', 'investigatorAffiliation': 'Turku University Hospital'}}}}