Memory for Music: Individual Intensive Musical Training in Alzheimer's Disease
NCT ID: NCT06611878
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
113 participants
INTERVENTIONAL
2024-12-01
2027-10-01
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Intensive followed by minimal music training
Music training conducted by a trained instructor (music therapist or music educator):
2 sessions per week for 5 months (intensive); no intervention for 2 months (washout period);
1 session per month for 5 months (minimal).
Music training - intensive
Music 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
Music 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)
Medications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation.
Minimal followed by intensive music training
Music training conducted by a trained instructor (music therapist or music educator):
1. session per month for 5 months (minimal); no intervention for 2 months (washout period);
2. sessions per week for 5 months (intensive).
Music training - intensive
Music 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
Music 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)
Medications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation.
Interventions
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Music training - intensive
Music 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
Music 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)
Medications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation.
Eligibility Criteria
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Inclusion Criteria
* Home-dwelling
* Non-musician
Exclusion Criteria
* Living in care home
* History as a professional musician
65 Years
ALL
No
Sponsors
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Universidad de Ciencias Empresariales y Sociales, Buenos Aires, Argentina
UNKNOWN
University of Vienna
OTHER
University of Bergen
OTHER
Universidad Nacional de Entre Rios
OTHER
Kinn Municipality, Norway
UNKNOWN
Oslo Municipality
OTHER_GOV
Norwegian Association for Music Therapy
UNKNOWN
Oslo Dementia Association
UNKNOWN
NORCE Norwegian Research Centre AS
OTHER
Responsible Party
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Locations
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Universidad de Ciencias Empresariales y Sociales
Buenos Aires, , Argentina
University of Vienna
Vienna, , Austria
University of Bergen
Bergen, Vestland, Norway
Haraldsplass Diakonale Sykehus
Bergen, Vestland, Norway
Kinn municipality
Florø, , Norway
Oslo municipality
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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Marcela Lichtensztejn
Role: primary
Anja-Xiaoxing Cui
Role: primary
Elias Langeland
Role: primary
Ragnhild Skogseth
Role: primary
Jorunn B Nydal
Role: primary
Elin Linløkken
Role: primary
References
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Lichtensztejn M, Cui AX, Geretsegger M, Lundervold AJ, Koelsch S, Pfabigan DM, Assmus J, Langeland E, Ruiz M, Tabernig C, Skogseth RE, Gold C. Memory for Music (M4M) protocol for an international randomised controlled trial: effects of individual intensive musical training based on singing in non-musicians with Alzheimer's disease. BMJ Open. 2025 Oct 20;15(10):e095136. doi: 10.1136/bmjopen-2024-095136.
Related Links
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Project website
Other Identifiers
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344215
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
106684
Identifier Type: -
Identifier Source: org_study_id