About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Alzheimer's disease
Home-dwelling
Non-musician
Disqualifiers
Non-Alzheimer dementia
Living in care home
History as a professional musician
Trial design
Crossover
Treatments tested in this trial
Music training - intensive
BehavioralMusic training entails learning novel songs the participant chooses from a list. Songs are similar in complexity and length (number of words, high frequency words, harmony, musical complexity, length of verses and chorus). Offering a variety of songs allows to examine memory performance regardless of the specific song chosen. Sessions last 30 to 40 minutes, conducted based on a manual (1. mood observation; 2. warm-up; 3. teaching the chorus, observed liking of song; 4. singing entire chorus; 5. singing chorus in context, 6. session closure with favourite song; 7. final mood observation; session rating), and are video-recorded. External evaluators audit the sessions video recordings to determine adherence to the manual. Sessions are offered twice a week for 5 months.
Music training - minimal
BehavioralMusic training entails learning novel songs the participant chooses from a list. Songs are similar in complexity and length (number of words, high frequency words, harmony, musical complexity, length of verses and chorus). Offering a variety of songs allows to examine memory performance regardless of the specific song chosen. Sessions last 30 to 40 minutes, conducted based on a manual (1. mood observation; 2. warm-up; 3. teaching the chorus, observed liking of song; 4. singing entire chorus; 5. singing chorus in context, 6. session closure with favourite song; 7. final mood observation; session rating), and are video-recorded. External evaluators audit the sessions video recordings to determine adherence to the manual. Sessions are offered once a month for 5 months.
Treatment as Usual (TAU)
Other interventionMedications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation.
Treatment groups
Trial outcomes
Primary outcomes
ADAS-cog
ADAS-cog is a scale developed to assess the level of cognitive dysfunction in individuals with Alzheimer's disease. The standard ADAS-cog includes the following 11 subtests, with a total scoring range from 0 (no impairment) to 70 (most severe impairments): word recall (0-10); commands (0-5); naming (0-5); constructional praxis (0-5); ideational praxis (0-5); orientation (0-8); word recognition (0-12); remembering word recognition test instructions (0-5); spoken language ability (0-5); comprehension of spoken language (0-5); word-finding difficulty (0-5). The ADAS-cog score is based on the number of errors made within each subtest.
EEG-ERP N400 in response to music stimuli
Electroencephalography (EEG) is a non-invasive method of measuring brain activity. Electrical potential from the brain is measured through electrodes on a cap fitted on the head of the participant. Event-related potentials (ERPs) in response to music violations (unexpected notes in songs) will be analysed to indicate implicit memory for learned music. Generally, ERPs are measured by averaging the EEG signal over multiple repetitions of the same stimulus response. In this study, ERP analyses will focus on amplitude variation of the N400 component, which is a negative inflection of the EEG signal around 400ms after the onset of a stimulus (here an unexpected note in a song presented via audio recording). It is measured in µV and results in a continuous variable. Because the direction of the N400 is negative, and a stronger response indicates better music memory, lower amplitudes values are interpreted as more favourable outcomes.
Secondary outcomes
Mood
Self-reported mood at beginning and end of each training session, using a 5-point scale with emojis (icons of faces where 1=sad and 5=happy; higher values mean better outcome).
Sense of Familiarity with current song (Instructor)
Rated by intervention provider during the training session. Ratings for estimated Sense of Familiarity: 1 - None; 2 - Implicit memory, mere exposure effect; 3 - Weak familiarity; 4 - Familiarity; 5 - Weak recollection; 6 - Recollection. For this study, a score of 4 or above is considered as the threshold to determine familiarity-based recognition.
Sense of Familiarity with current song (External Evaluator)
Rated by an external evaluator based on video recordings of training sessions. Ratings for estimated Sense of Familiarity: 1 - None; 2 - Implicit memory, mere exposure effect; 3 - Weak familiarity; 4 - Familiarity; 5 - Weak recollection; 6 - Recollection. For this study, a score of 4 or above is considered as the threshold to determine familiarity-based recognition.
Performance (chorus solo)
Performance (independent recall) of a learned song during solo performance, whether the participant needs full support / intermittent support / support in one syllable/word per line / is fully independent. Rated by an external evaluator based on video recordings of training sessions. Possible range 8-32, where highest is best.
Sponsors and contacts
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NORCE Norwegian Research Centre AS
Lead sponsor
Universidad de Ciencias Empresariales y Sociales, Buenos Aires, Argentina
Collaborator
University of Vienna
Collaborator
University of Bergen
Collaborator
Universidad Nacional de Entre Rios
Collaborator
Kinn Municipality, Norway
Collaborator
Oslo Municipality
Collaborator
Norwegian Association for Music Therapy
Collaborator
Oslo Dementia Association
Collaborator