ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients (ALMUTH)
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ClinicalTrials.gov Identifier: NCT03444181 |
Recruitment Status :
Recruiting
First Posted : February 23, 2018
Last Update Posted : October 13, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alzheimer Disease Mild Cognitive Impairment MCI With Increased Risk for Alzheimer Disease | Behavioral: Music lessons Behavioral: Training intervention | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 135 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients |
Actual Study Start Date : | April 11, 2018 |
Estimated Primary Completion Date : | June 2023 |
Estimated Study Completion Date : | June 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Music lessons |
Behavioral: Music lessons
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. |
Active Comparator: Training intervention |
Behavioral: Training intervention
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. |
No Intervention: No intervention |
- Brain age [ Time Frame: 12 months ]MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in months
- Depression symptoms [ Time Frame: 12 months ]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)
- Living independently at home [ Time Frame: 12 months and up to 5 years ]Whether a person still lives at home or has moved to a care home (time-to-event data)
- Language abilities [ Time Frame: 12 months ]Word Learning Test
- Sensori-motor functions [ Time Frame: 12 months ]Finger Tapping Test
- Activities of daily living [ Time Frame: 12 months ]Instrumental Activities of Daily Living (IADL)
- Disease progression [ Time Frame: 12 months ]Mini-Mental State Examination (MMSE)
- Cognitive functioning [ Time Frame: 12 months ]Stroop test, online version
- Integrity of fibre tracts [ Time Frame: 12 months ]Estimated from Diffusion Tensor Imaging (DTI)
- Resting-state functional connectivity [ Time Frame: 12 months ]Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN)
- Working alliance [ Time Frame: 6 months ]Working Alliance Inventory-Short Revised (WAI-SR)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444181
Contact: Stefan Koelsch, PhD | +47 55 58 62 31 | stefan.koelsch@uib.no | |
Contact: Birthe K Flo, Cand. PhD | +47 55 58 62 09 | Birthe.Flo@uib.no |
Norway | |
Bergen Municipality | Recruiting |
Bergen, Hordaland, Norway | |
Contact: Marianne Solbakk, PhD |
Principal Investigator: | Stefan Koelsch, PhD | University of Bergen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Stefan Koelsch, Professor, University of Bergen |
ClinicalTrials.gov Identifier: | NCT03444181 |
Other Study ID Numbers: |
RCN 260576 |
First Posted: | February 23, 2018 Key Record Dates |
Last Update Posted: | October 13, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders |