NCT03444181

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
136

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

6.2 years

First QC Date

February 16, 2018

Last Update Submit

May 7, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Living independently at home

    12 months and up to 5 years

  • Language abilities

    12 months

  • Sensori-motor functions

    12 months

  • Activities of daily living

    12 months

  • Disease progression

    12 months

  • +4 more secondary outcomes

Study Arms (3)

Music lessons

EXPERIMENTAL
Behavioral: Music lessons

Training intervention

ACTIVE COMPARATOR
Behavioral: Training intervention

No intervention

NO INTERVENTION

Interventions

Music lessonsBEHAVIORAL

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.

Music lessons

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.

Training intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bergen Municipality

Bergen, Hordaland, Norway

Location

Related Publications (3)

  • van der Steen JT, van der Wouden JC, Methley AM, Smaling HJA, Vink AC, Bruinsma MS. Music-based therapeutic interventions for people with dementia. Cochrane Database Syst Rev. 2025 Mar 7;3(3):CD003477. doi: 10.1002/14651858.CD003477.pub5.

  • Matziorinis AM, Flo BK, Skouras S, Dahle K, Henriksen A, Hausmann F, Sudmann TT, Gold C, Koelsch S. A 12-month randomised pilot trial of the Alzheimer's and music therapy study: a feasibility assessment of music therapy and physical activity in patients with mild-to-moderate Alzheimer's disease. Pilot Feasibility Stud. 2023 Apr 19;9(1):61. doi: 10.1186/s40814-023-01287-1.

  • 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.

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Stefan Koelsch, PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 16, 2018

First Posted

February 23, 2018

Study Start

April 11, 2018

Primary Completion

June 14, 2024

Study Completion

June 14, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations