- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04132193
Processing of Music in Alzheimer Patients (MUKU-DEM)
Correlation of Musicality and Cognitive Skills in Persons With Alzheimer´s Disease
Study Overview
Status
Conditions
Detailed Description
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.
Music 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.
Aims 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.
Voluntary 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Seppo Soinila, MD PhD
- Phone Number: +358503463396
- Email: seppo.soinila@tyks.fi
Study Contact Backup
- Name: Pavel Zaitsev, B.Sc.
- Email: pavel.p.zaitsev@utu.fi
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosed Alzheimer´s disease
Exclusion Criteria:
Other neurological comorbidity, substance abuse
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montreal Battery of Evaluation of Amusia
Time Frame: 60 minutes
|
Number of correct answers in three task collections (total 79 tasks)
|
60 minutes
|
Brain atrophy in MRI scans
Time Frame: 120 minutes
|
Loss of volume in brain regions relevant for music processing and in the hippocampi estimated by voxel-based morphometry
|
120 minutes
|
CERAD (Consortium for Establishing Registry of Alzheimer´s Disease)
Time Frame: 30 minutes
|
Level of cognitive impairment
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of music in patient´s daily life
Time Frame: 30 minutes
|
Validated self-report questionnaire MusEQ in Finnish, Likert scale 1-5 (Vanstone AD et al, Aging Ment Health 2016)
|
30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Seppo Soinila, MD PhD, Turku University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- T112/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Dementia
-
University of North Carolina, Chapel HillNational Institute on Aging (NIA)CompletedAlzheimer Dementia | Dementia Alzheimers | CaregiverUnited States
-
Temple UniversityRecruitingDementia | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
Hebrew SeniorLifeRecruitingAging | Alzheimer Dementia | Presenile Alzheimer DementiaUnited States
-
Temple UniversityRecruitingDementia | Alzheimer Disease | Mild Cognitive Impairment | Dementia, Vascular | Dementia, Mixed | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Dementia, MildUnited States
-
National Tainan Junior College of NursingCompletedCognitive Impairment | Dementia, Mild | Dementia ModerateTaiwan
-
Karen RobertoNational Institute on Aging (NIA)RecruitingDementia | Dementia Alzheimers | Neuro-Degenerative Disease | Dementia of Alzheimer Type | Dementia SevereUnited States
-
Cognito Therapeutics, Inc.Enrolling by invitationExtension to a Pivotal Study of Sensory Stimulation in Alzheimer's Disease (OLE Hope Study, CA-0015)Cognitive Impairment | Alzheimer Disease | Mild Cognitive Impairment | Dementia Alzheimers | Dementia of Alzheimer Type | AD | Dementia, Mild | Dementia ModerateUnited States
-
University College, LondonNot yet recruitingDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal | DEM
-
University College, LondonThe University of Hong KongUnknownDementia | Dementia, Vascular | Dementia, Mixed | Dementia With Lewy Bodies | Dementia of Alzheimer Type | Dementia Moderate | Dementia Severe | Dementia Frontal
-
Karolinska InstitutetRegion Stockholm; KTH Royal Institute of TechnologyActive, not recruitingAlzheimer Dementia | Dementia DisordersSweden