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Alzheimer DiseaseMUKU-DEMNCT04132193

Processing of Music in Alzheimer Patients

An observational study of Alzheimer Disease and Dementia, run by Turku University Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Seppo Soinila, MD PhD contact

+358503463396

seppo.soinila@tyks.fi

Pavel Zaitsev, B.Sc. contact

pavel.p.zaitsev@utu.fi

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.

Medical subject headings
Alzheimer Disease, Dementia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Montreal Battery of Evaluation of Amusia

    Number of correct answers in three task collections (total 79 tasks)

    Measured: 60 minutes

  2. 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

  3. CERAD (Consortium for Establishing Registry of Alzheimer´s Disease)

    Level of cognitive impairment

    Measured: 30 minutes

Secondary outcomes (1)
  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.

  1. First posted18 Oct 2019
  2. Study startOct 2019 (estimated)
  3. Primary completionMay 2020 (estimated)
  4. Study completionMay 2021 (estimated)

Resources

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)
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

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.

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