ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients (ALMUTH)
Primary Purpose
Alzheimer Disease, Mild Cognitive Impairment, MCI With Increased Risk for Alzheimer Disease
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Music lessons
Training intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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)
Sites / Locations
- Bergen MunicipalityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
Music lessons
Training intervention
No intervention
Arm Description
Outcomes
Primary Outcome Measures
Brain age
MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in 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)
Secondary Outcome Measures
Living independently at home
Whether a person still lives at home or has moved to a care home (time-to-event data)
Language abilities
Word Learning Test
Sensori-motor functions
Finger Tapping Test
Activities of daily living
Instrumental Activities of Daily Living (IADL)
Disease progression
Mini-Mental State Examination (MMSE)
Cognitive functioning
Stroop test, online version
Integrity of fibre tracts
Estimated from Diffusion Tensor Imaging (DTI)
Resting-state functional connectivity
Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN)
Working alliance
Working Alliance Inventory-Short Revised (WAI-SR)
Full Information
NCT ID
NCT03444181
First Posted
February 16, 2018
Last Updated
November 21, 2022
Sponsor
University of Bergen
Collaborators
NORCE Norwegian Research Centre AS, Bergen Municipality
1. Study Identification
Unique Protocol Identification Number
NCT03444181
Brief Title
ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients
Acronym
ALMUTH
Official Title
ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
NORCE Norwegian Research Centre AS, Bergen Municipality
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment, MCI With Increased Risk for Alzheimer Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Music lessons
Arm Type
Experimental
Arm Title
Training intervention
Arm Type
Active Comparator
Arm Title
No intervention
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Music lessons
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brain age
Description
MRI-derived estimation of the deviation of a person's brain age from the chronological age of that same person, in months
Time Frame
12 months
Title
Depression symptoms
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Living independently at home
Description
Whether a person still lives at home or has moved to a care home (time-to-event data)
Time Frame
12 months and up to 5 years
Title
Language abilities
Description
Word Learning Test
Time Frame
12 months
Title
Sensori-motor functions
Description
Finger Tapping Test
Time Frame
12 months
Title
Activities of daily living
Description
Instrumental Activities of Daily Living (IADL)
Time Frame
12 months
Title
Disease progression
Description
Mini-Mental State Examination (MMSE)
Time Frame
12 months
Title
Cognitive functioning
Description
Stroop test, online version
Time Frame
12 months
Title
Integrity of fibre tracts
Description
Estimated from Diffusion Tensor Imaging (DTI)
Time Frame
12 months
Title
Resting-state functional connectivity
Description
Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN)
Time Frame
12 months
Title
Working alliance
Description
Working Alliance Inventory-Short Revised (WAI-SR)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Koelsch, PhD
Phone
+47 55 58 62 31
Email
stefan.koelsch@uib.no
First Name & Middle Initial & Last Name or Official Title & Degree
Birthe K Flo, Cand. PhD
Phone
+47 55 58 62 09
Email
Birthe.Flo@uib.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Koelsch, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bergen Municipality
City
Bergen
State/Province
Hordaland
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Solbakk, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35771851
Citation
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.
Results Reference
derived
Links:
URL
http://www.uib.no/en/brainandmusic/112850/alzheimer-and-music
Description
Project website
Learn more about this trial
ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients
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