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

Study Overview
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Brief Summary
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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.

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

Conditions
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Alzheimer Disease, Mild Cognitive Impairment, MCI With Increased Risk for Alzheimer Disease

Intervention / Treatment
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* Behavioral: Music lessons
* Behavioral: Training intervention


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music lessons<br> | Behavioral: Music lessons<br>* 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.<br>|
| Active Comparator: Training intervention<br> | Behavioral: Training intervention<br>* 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.<br>|
| No Intervention: No intervention<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain age | MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in months | 12 months | 
| 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) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Living independently at home | Whether a person still lives at home or has moved to a care home (time-to-event data) | 12 months and up to 5 years | 
| Language abilities | Word Learning Test | 12 months | 
| Sensori-motor functions | Finger Tapping Test | 12 months | 
| Activities of daily living | Instrumental Activities of Daily Living (IADL) | 12 months | 
| Disease progression | Mini-Mental State Examination (MMSE) | 12 months | 
| Cognitive functioning | Stroop test, online version | 12 months | 
| Integrity of fibre tracts | Estimated from Diffusion Tensor Imaging (DTI) | 12 months | 
| Resting-state functional connectivity | Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN) | 12 months | 
| Working alliance | Working Alliance Inventory-Short Revised (WAI-SR) | 6 months |