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Alzheimer DiseaseALMUTHNCT03444181

ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients

A study testing Music lessons and Training intervention in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of Bergen at 1 site in Norway.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Music has powerful effects on memory in patients with neurodegenerative diseases. However, although there is anecdotal evidence for beneficial effects of active music interventions in patients with Alzheimer's disease (AD), there is lack of high-quality research investigating this issue, and the cognitive, emotional… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Music lessons and Training intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
1 siteNorway
Study dates
11 Apr 2018to 14 Jun 2024
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Alzheimer Disease
  • Living independently at home (not in a care home or similar aged care facility)
  • Able to complete questionnaires in Norwegian
  • Able to undergo MRI scans
  • Able to attend interventions and assessments in the area of Bergen, Norway
  • Has given informed consent

Who cannot join

  • Hearing impairment that cannot be mended by hearing aids
  • Conditions that hinder MRI scans, such as claustrophobia or metal objects in body (e.g. pacemakers)

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Bergen Municipality

    Bergen, Hordaland

Other trials in Norway

About this study

Music has powerful effects on memory in patients with neurodegenerative diseases. However, although there is anecdotal evidence for beneficial effects of active music interventions in patients with Alzheimer's disease (AD), there is lack of high-quality research investigating this issue, and the cognitive, emotional, and social factors that contribute to potentially beneficial effects of music making in AD patients are largely unknown. In a randomised controlled intervention trial, a cohort of AD patients will undergo twelve months of music lessons specifically tailored for AD patients. Structural and functional magnetic resonance imaging (MRI) will be used to determine changes in brain age (as compared to two control groups), and voxel-based morphometry will be computed to determine contributions of different factors of the music intervention (cognitive, emotional, and social) to plastic changes of brain morphology, and a potential deceleration of brain atrophy. In addition, quality of life of patients. In cooperation with the Bergen municipality, and a strong network of national and international partners, the neurocognitive music therapy will be implemented, involving training of music therapists, and communication of results to patients, patient groups, and therapists.

Being tested
Music lessons, Training intervention
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music lessonsBehavioural

    Also described as neurocognitive music therapy. Singing lessons will be provided once a week for a period of 12 months by a person with a qualification in music therapy, or by a person with a different relevant qualification (e.g. psychology and music teaching) under the supervision of a music therapist. Additionally, participants will have the opportunity to meet regularly (1-2 times per month) as a choir to sing the song they have learned together in a group.

  • Training interventionBehavioural

    Cognitive training that is comparable in scope and extent to the music lessons, but not using music. Group training sessions will be provided once a week for a period of 12 months by a person with a qualification in physiotherapy or occupational therapy. Group activities may include group tours such as mountain hikes and the like (about 2 times per month) and will follow an established program for the elderly.

Study groups in NCT03444181
Study groupRoleWhat they receive
Music lessonsExperimentalNot described
Receives: Behavioral: Music lessons
Training interventionActive comparatorNot described
Receives: Behavioral: Training intervention
No interventionNo interventionNot described

What is being measured

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

  1. Brain age

    MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in months

    Measured: 12 months

  2. Depression symptoms

    Sum score of the Geriatric Depression Scale (GDS; 15 yes/no items; possible range of scores 0-15; higher scores indicating more severe depression symptoms)

    Measured: 12 months

Secondary outcomes (9)

  1. Living independently at home

    Whether a person still lives at home or has moved to a care home (time-to-event data)

    Measured: 12 months and up to 5 years

  2. Language abilities

    Word Learning Test

    Measured: 12 months

  3. Sensori-motor functions

    Finger Tapping Test

    Measured: 12 months

  4. Activities of daily living

    Instrumental Activities of Daily Living (IADL)

    Measured: 12 months

  5. Disease progression

    Mini-Mental State Examination (MMSE)

    Measured: 12 months

  6. Cognitive functioning

    Stroop test, online version

    Measured: 12 months

  7. Integrity of fibre tracts

    Estimated from Diffusion Tensor Imaging (DTI)

    Measured: 12 months

  8. Resting-state functional connectivity

    Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN)

    Measured: 12 months

  9. Working alliance

    Working Alliance Inventory-Short Revised (WAI-SR)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start11 Apr 2018
  3. Primary completion14 Jun 2024 (estimated)
  4. Study completion14 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03444181
Sponsor's protocol ID
RCN 260576
Acronym
ALMUTH
Status last verified
May 2024
First submitted
16 Feb 2018
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

    PubMed 40049590

  • Matziorinis AM, Flo BK, Skouras S, Dahle K, Henriksen A, Hausmann F, Sudmann TT, Gold C, Koelsch S. A 12-month randomised pilot trial of the Alzheimer's and music therapy study: a feasibility assessment of music therapy and physical activity in patients with mild-to-moderate Alzheimer's disease. Pilot Feasibility Stud. 2023 Apr 19;9(1):61. doi: 10.1186/s40814-023-01287-1.

    PubMed 37076884

  • Flo BK, Matziorinis AM, Skouras S, Sudmann TT, Gold C, Koelsch S. Study protocol for the Alzheimer and music therapy study: An RCT to compare the efficacy of music therapy and physical activity on brain plasticity, depressive symptoms, and cognitive decline, in a population with and at risk for Alzheimer's disease. PLoS One. 2022 Jun 30;17(6):e0270682. doi: 10.1371/journal.pone.0270682. eCollection 2022.

    PubMed 35771851

Questions about this trial

What is this clinical trial studying?

A study testing Music lessons and Training intervention in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of Bergen at 1 site in Norway.

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 6 inclusion and 2 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brain age (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03444181, which also lists 3 linked publications.

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 8 May 2024.

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