Clinical trial NCT03444181: ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients
Official title: ALzheimer and MUsic THerapy: Effects of Music Lessons on Brain Plasticity, Mood, and Quality of Life in Alzheimer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
MCI With Increased Risk for Alzheimer Disease
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: NORCE Norwegian Research Centre AS
name: Bergen Municipality
First posted: 2018-02-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Brain age
timeFrame: 12 months
measure: Depression symptoms
timeFrame: 12 months
Secondary outcomes:
measure: Living independently at home
timeFrame: 12 months and up to 5 years
measure: Language abilities
timeFrame: 12 months
measure: Sensori-motor functions
timeFrame: 12 months
measure: Activities of daily living
timeFrame: 12 months
measure: Disease progression
timeFrame: 12 months
measure: Cognitive functioning
timeFrame: 12 months
measure: Integrity of fibre tracts
timeFrame: 12 months
measure: Resting-state functional connectivity
timeFrame: 12 months
measure: Working alliance
timeFrame: 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen Municipality
state: Hordaland
Study officials:
affiliation: University of Bergen
name: Stefan Koelsch, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.