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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; MCI With Increased Risk for Alzheimer Disease
• Intervention / Treatment: Behavioral: Music lessons; Behavioral: Training intervention

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Koelsch, PhD; Phone Number: +47 55 58 62 31; Email: stefan.koelsch@uib.no
• Study Contact Backup: Name: Birthe K Flo, Cand. PhD; Phone Number: +47 55 58 62 09; Email: Birthe.Flo@uib.no

Study Locations

• Norway
  • Hordaland
    • Bergen, Hordaland, Norway
      • Recruiting
      • Bergen Municipality
      • Contact: Marianne Solbakk, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: NORCE Norwegian Research Centre AS; Bergen Municipality
• Investigators: Principal Investigator: Stefan Koelsch, PhD, University of Bergen

Publications and helpful links

General Publications

• 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.

Helpful Links

• Project website

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2018
• Primary Completion (ANTICIPATED): March 1, 2024
• Study Completion (ANTICIPATED): March 1, 2024

Study Registration Dates

• First Submitted: February 16, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: RCN 260576

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No