CClinicalTrials.gg
Active, not recruitingNCT03444181ALMUTHUpdated May 8, 2024

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

An interventional study of Music lessons and Training intervention in Alzheimer Disease, Mild Cognitive Impairment and MCI With Increased Risk for Alzheimer Disease, sponsored by University of Bergen. Active, not recruiting at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Bergen · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease
  • Mild Cognitive Impairment
  • MCI With Increased Risk for Alzheimer Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
136 participants (actual)

Study arms

  • Experimental
    Music lessons

    Behavioral: Music lessons

  • Active comparator
    Training intervention

    Behavioral: Training intervention

  • No intervention
    No intervention

Interventions

  • BehavioralMusic 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.

  • BehavioralTraining 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.

05

What researchers measure

Primary outcomes

  1. Brain age

    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

  2. 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)

    Time frame: 12 months

Secondary outcomes

  1. Living independently at home

    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

  2. Language abilities

    Word Learning Test

    Time frame: 12 months

  3. Sensori-motor functions

    Finger Tapping Test

    Time frame: 12 months

  4. Activities of daily living

    Instrumental Activities of Daily Living (IADL)

    Time frame: 12 months

  5. Disease progression

    Mini-Mental State Examination (MMSE)

    Time frame: 12 months

  6. Cognitive functioning

    Stroop test, online version

    Time frame: 12 months

  7. Integrity of fibre tracts

    Estimated from Diffusion Tensor Imaging (DTI)

    Time frame: 12 months

  8. Resting-state functional connectivity

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

    Time frame: 12 months

  9. Working alliance

    Working Alliance Inventory-Short Revised (WAI-SR)

    Time frame: 6 months

06

Study locations

1 site
  • Bergen Municipality
    Bergen, Hordaland, Norway
07

References and documents

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. PubMed 35771851 ↗

Related links

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03444181
Lead sponsor
University of Bergen
Collaborators
NORCE Norwegian Research Centre AS, Bergen Municipality
Responsible party
Stefan Koelsch (Professor, University of Bergen) — Principal investigator
First posted
Feb 23, 2018
Start date
Apr 11, 2018
Primary completion
Jun 14, 2024 (estimated)
Completion
Jun 14, 2024 (estimated)
Last update
May 8, 2024

Study contacts

Stefan Koelsch, PhD
principal investigator · University of Bergen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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