Clinical trial NCT06611878: Memory for Music: Individual Intensive Musical Training in Alzheimer's Disease
Official title: Memory for Music: Effects of Individual Intensive Musical Training Based on Singing in Non-musicians With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: music and memory
N400
music-based intervention
music therapy
dementia
cognition
mood
Lead sponsor: NORCE Norwegian Research Centre AS
Sponsor class: OTHER
Collaborators: name: Universidad de Ciencias Empresariales y Sociales, Buenos Aires, Argentina
name: University of Vienna
name: University of Bergen
name: Universidad Nacional de Entre Rios
name: Kinn Municipality, Norway
name: Oslo Municipality
name: Norwegian Association for Music Therapy
name: Oslo Dementia Association
First posted: 2024-09-25
Enrollment: 113
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised crossover design
Primary purpose: TREATMENT

Brief summary: This project, called Memory for Music, focuses on the increasing number of people worldwide living with dementia, especially Alzheimer's disease (AD). AD typically starts with memory problems and eventually affects daily activities. Active music interventions, especially singing, have shown positive effects on mood, behavior, and quality of life for people with dementia, but their impact on cognition is not well understood. The project aims to address this gap by studying the effects of learning new songs on cognitive, behavioral, and brain functioning.

The study will involve home-dwelling adults aged 65 or older with AD from Argentina, Austria, and Norway. Participants will undergo 5 months of intensive musical training (twice a week) and 5 months of minimal training (once a month) in a random order, with a 2-month break in between. The interventions include learning new songs with a personal music teacher. General cognition will be measured using the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog), and memory for music will be assessed through various methods, including behavioral tasks and brain responses (EEG). Mood will also be evaluated in each session.

The goal is to include 113 participants to ensure reliable detection of meaningful effects. The study will explore how mood and memory for music contribute to changes in cognitive abilities, and whether these effects vary based on factors such as sex, age, AD stage, or previous musical training and general education. The project emphasizes collaboration between researchers, service providers, and users to ensure the study's relevance and applicability.

Detailed description: The number of people living with dementia is increasing and is high in low, middle, and high-income countries. Alzheimer's disease (AD), the most common type of dementia, manifests itself initially with cognitive impairment in memory domains, and later affects all activities of daily living. Active music interventions, particularly singing, can help to improve mood, behaviour problems, and quality of life. Too little is known about their effects on cognition, although some promising studies exist. The M4M project aims to fill this gap by measuring effects of learning new songs on clinical, behavioural and brain functioning. Specifically, M4M aims to examine changes in general cognitive functioning and memory for music in non-musician adults with AD undergoing intensive individual musical training based on singing novel songs, compared to minimal training.

Home-dwelling adults with AD, 65 years or older, in 3 countries (Argentina, Austria, Norway), will receive 5 months of intensive intervention (2x/week) and 5 months of minimal intervention (1x/month), in random order, with a 2-month break in between. Interventions will entail learning new songs with an individual music teacher. At the end of each intervention period, general cognition will be measured with the Alzheimer's Disease Assessment Scale - Cognitive (ADAS-cog) by a person who is unaware of the intervention received. Memory for music will be tested with observations, behavioural tasks, and brain responses (EEG). Mood will be assessed in each session. The investigators aim to include 113 participants; this will help us to reliably detect clinically meaningful effects. The investigators will also examine how mood and memory for music lead to changes in cognitive abilities, and whether effects depend on sex, age, AD stage, or previous musical training or general education. M4M will be conducted in close collaboration between academic researchers, service providers, and service users to ensure relevance and applicability.

Behavioural assessment will be conducted by the instructors and by external evaluators at specific points of the musical training. Mood will be assessed using a 5-point emoji scale, and Sense of Familiarity with the current song will be estimated using a scale that takes into account verbal and behavioural cues; both measures were developed for the purpose of this study.

EEG measures will be collected while participants listen to both unknown melodies and melodies they have learned during the intervention period, and the investigators wish to assess whether in-key violations in known songs will elicit an N400-like event related potential. If participants develop musical semantic memory through our intervention, the investigators expect them to show this N400-like component to in-key violations in familiarized melodies, i.e., those melodies that are introduced and learned during our intervention, but only after the intervention. If an N400 component is detectable during these in-key violations of a newly learned song, it will indicate memory of the new song even if the participant is unable to adhere to a behavioural task or display an observable sense of familiarity. The in-key violations will be introduced at multiple places throughout each melody, which will consist of at least 32 bars. A total of 10 melodies will be played for each participant, of which half are learned in an intervention period (familiarized/to be familiarized). In each of the melodies the investigators will include at least 8 in-key violations. ERPs in response to these in-key violations will be compared to ERPs in response to unchanged notes in structurally similar places in each melody.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Alzheimer's disease
* Home-dwelling
* Non-musician

Exclusion Criteria:

* Non-Alzheimer dementia
* Living in care home
* History as a professional musician

Primary outcomes:
measure: ADAS-cog
timeFrame: 0, 5, 7, 12 months
measure: EEG-ERP N400 in response to music stimuli
timeFrame: 0, 5, 7, 12 months
Secondary outcomes:
measure: Mood
timeFrame: Beginning and end of each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.
measure: Sense of Familiarity with current song (Instructor)
timeFrame: During each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.
measure: Sense of Familiarity with current song (External Evaluator)
timeFrame: At the end of selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
measure: Performance (chorus solo)
timeFrame: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
measure: Performance (chorus in context)
timeFrame: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
measure: Adverse events
timeFrame: 5, 7, 12 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Universidad de Ciencias Empresariales y Sociales
city: Vienna
country: Austria
facility: University of Vienna
city: Bergen
country: Norway
facility: University of Bergen
state: Vestland
city: Bergen
country: Norway
facility: Haraldsplass Diakonale Sykehus
state: Vestland
city: Florø
country: Norway
facility: Kinn municipality
city: Oslo
country: Norway
facility: Oslo municipality
Study officials:
References: