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

Alzheimer Disease Clinical Trial

— ALMUTH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03444181
• Other study ID #: RCN 260576
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: June 14, 2024

Study information

• Verified date: May 2024
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: June 14, 2024
• Est. primary completion date: June 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Bergen Municipality	Bergen	Hordaland

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Bergen Municipality, NORCE Norwegian Research Centre AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Living independently at home	Whether a person still lives at home or has moved to a care home (time-to-event data)	12 months and up to 5 years
Secondary	Language abilities	Word Learning Test	12 months
Secondary	Sensori-motor functions	Finger Tapping Test	12 months
Secondary	Activities of daily living	Instrumental Activities of Daily Living (IADL)	12 months
Secondary	Disease progression	Mini-Mental State Examination (MMSE)	12 months
Secondary	Cognitive functioning	Stroop test, online version	12 months
Secondary	Integrity of fibre tracts	Estimated from Diffusion Tensor Imaging (DTI)	12 months
Secondary	Resting-state functional connectivity	Functional connectivity (posterior versus anterior/ventral) in default mode network (DMN)	12 months
Secondary	Working alliance	Working Alliance Inventory-Short Revised (WAI-SR)	6 months

External Links

•   Project website