Alzheimer DiseaseMUKU-DEMNCT04132193
Processing of Music in Alzheimer Patients
An observational study of Alzheimer Disease and Dementia, run by Turku University Hospital.
Trial summary
Correlation of musicality, brain atrophy in brain areas relevant for music processing and the stage of Alzheimer´s disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer Disease, Dementia, Amusia
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to May 2021
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients of Southwest Finland Hospital District
Who may be able to join
- Diagnosed Alzheimer´s disease
Who cannot join
- Other neurological comorbidity, substance abuse
Trial locations and contacts
No sites are listed yet.
Pavel Zaitsev, B.Sc. contact
About this study
Official title: Correlation of Musicality and Cognitive Skills in Persons With Alzheimer´s Disease
Correlation of musicality, brain atrophy in brain areas relevant for music processing and the stage of Alzheimer´s disease.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Amusia
- Medical subject headings
- Alzheimer Disease, Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Battery of Evaluation of Amusia
Number of correct answers in three task collections (total 79 tasks)
Measured: 60 minutes
Brain atrophy in MRI scans
Loss of volume in brain regions relevant for music processing and in the hippocampi estimated by voxel-based morphometry
Measured: 120 minutes
CERAD (Consortium for Establishing Registry of Alzheimer´s Disease)
Level of cognitive impairment
Measured: 30 minutes
Secondary outcomes (1)
Use of music in patient´s daily life
Validated self-report questionnaire MusEQ in Finnish, Likert scale 1-5 (Vanstone AD et al, Aging Ment Health 2016)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study startOct 2019 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Seppo Soinila, Turku University Hospital
- Investigators
- Seppo Soinila, MD PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132193
- Sponsor's protocol ID
- T112/2019
- Acronym
- MUKU-DEM
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 25 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Musicality and Cognitive Skills in Persons With Alzheimer´s Disease
- ClinicalTrials.gov ID
- NCT04132193
- Acronym / sponsor ID
- MUKU-DEM / T112/2019
- Conditions
- Alzheimer Disease, Dementia, Amusia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- Oct 2019 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 18 Oct 2019 (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.
Correlation of musicality, brain atrophy in brain areas relevant for music processing and the stage of Alzheimer´s disease.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of Southwest Finland Hospital District
Key inclusion criteria (1 listed)
- Diagnosed Alzheimer´s disease
Key exclusion criteria (1 listed)
- Other neurological comorbidity, substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montreal Battery of Evaluation of Amusia
Time frame: 60 minutes
Number of correct answers in three task collections (total 79 tasks)
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
CERAD (Consortium for Establishing Registry of Alzheimer´s Disease)
Time frame: 30 minutes
Level of cognitive impairment
1 secondary outcome
Use of music in patient´s daily life
Time frame: 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Pavel Zaitsev, B.Sc. contact
Seppo Soinila, MD PhD principal investigator
Turku University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Dementia, run by Turku University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seppo Soinila, MD PhD (+358503463396, seppo.soinila@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Battery of Evaluation of Amusia (time frame: 60 minutes). 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 25 Oct 2019.