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

Sponsor
University of Bergen (Other)
Overall Status
Recruiting
CT.gov ID
NCT03444181
Collaborator
NORCE Norwegian Research Centre AS (Other), Bergen Municipality (Other)
135
1
3
61.7
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Music lessons
  • Behavioral: Training intervention
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 11, 2018
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Brain age [12 months]

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

  2. Depression symptoms [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)

Secondary Outcome Measures

  1. Living independently at home [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)

  2. Language abilities [12 months]

    Word Learning Test

  3. Sensori-motor functions [12 months]

    Finger Tapping Test

  4. Activities of daily living [12 months]

    Instrumental Activities of Daily Living (IADL)

  5. Disease progression [12 months]

    Mini-Mental State Examination (MMSE)

  6. Cognitive functioning [12 months]

    Stroop test, online version

  7. Integrity of fibre tracts [12 months]

    Estimated from Diffusion Tensor Imaging (DTI)

  8. Resting-state functional connectivity [12 months]

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

  9. Working alliance [6 months]

    Working Alliance Inventory-Short Revised (WAI-SR)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bergen Municipality Bergen Hordaland Norway

Sponsors and Collaborators

  • University of Bergen
  • NORCE Norwegian Research Centre AS
  • Bergen Municipality

Investigators

  • Principal Investigator: Stefan Koelsch, PhD, University of Bergen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Stefan Koelsch, Professor, University of Bergen
ClinicalTrials.gov Identifier:
NCT03444181
Other Study ID Numbers:
  • RCN 260576
First Posted:
Feb 23, 2018
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2021