Alzheimer DiseaseM4MNCT06611878
Memory for Music: Individual Intensive Musical Training in Alzheimer's Disease
A study testing Music training - intensive, Music training - minimal and Treatment as Usual (TAU) in people with Alzheimer Disease, run by NORCE Norwegian Research Centre AS at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Music training - intensive, Music training - minimal and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Dec 2024to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of Alzheimer's disease
- Home-dwelling
- Non-musician
Who cannot join
- Non-Alzheimer dementia
- Living in care home
- History as a professional musician
Trial locations and contacts
6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 3 countries
Norway4 sites, 4 recruiting
- Recruiting
University of Bergen
Bergen, Vestland, 5020
Elias Langeland, 004790628887, elil@norceresearch.no
- Recruiting
Haraldsplass Diakonale Sykehus
Bergen, Vestland, 5892
Ragnhild Skogseth, ragnhild.eide.skogseth@haraldsplass.no
- Recruiting
Kinn municipality
Florø
Jorunn B Nydal, jorunn.nydal@kinn.kommune.no
- Recruiting
Oslo municipality
Oslo
Elin Linløkken, elin.linlokken@bna.oslo.kommune.no
Argentina1 site, 1 recruiting
- Recruiting
Universidad de Ciencias Empresariales y Sociales
Buenos Aires
Marcela Lichtensztejn, marcela.lichtensztejn@gmail.com
Austria1 site, 1 recruiting
- Recruiting
University of Vienna
Vienna
Anja-Xiaoxing Cui, anja-xiaoxing.cui@univie.ac.at
About this study
Official title: Memory for Music: Effects of Individual Intensive Musical Training Based on Singing in Non-musicians With Alzheimer's Disease
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Music training - intensive, Music training - minimal, Treatment as Usual (TAU)
- Keywords
- music and memory, N400, music-based intervention, music therapy, dementia, cognition, mood
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music training - intensiveBehavioural
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 - minimalBehavioural
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.
Medications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation.
| Study group | Role | What they receive |
|---|---|---|
| Intensive followed by minimal music training | Experimental | 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). Receives: Behavioral: Music training - intensive; Behavioral: Music training - minimal; Other: Treatment as Usual (TAU) |
| Minimal followed by intensive music training | Experimental | 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). Receives: Behavioral: Music training - intensive; Behavioral: Music training - minimal; Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 5, 7, 12 months
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.
Measured: 0, 5, 7, 12 months
Secondary outcomes (8)
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).
Measured: Beginning and end of each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.
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.
Measured: During each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.
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.
Measured: 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.
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.
Measured: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
Performance (chorus in context)
Performance (independent recall) of a learned song during performance in context, 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 2-8, where highest is best.
Measured: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
Adverse events
The investigators will ask participants or relatives at each assessment time point about the occurrence and a description of any serious or non-serious adverse events (AEs). Potentially study-related serious AEs, as well as unblinded frequency counts of any AEs, will be shared and discussed with the Data Monitoring and Safety Committee (DSMC) through the trial statistician.
Measured: 5, 7, 12 months
Structural brain characteristics
Assessed using quantitative and diffusion-weighted magnetic resonance imaging (MRI; 3 Tesla).
This outcome measure will only be included at the Vienna site.
Measured: 0, 5 months
Functional brain connectivity metrics
Assessed during task-free resting state functional magnetic resonance imaging (fMRI: 3 Tesla).
This outcome measure will only be included at the Vienna site.
Measured: 0, 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start1 Dec 2024
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised crossover design
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NORCE Norwegian Research Centre AS
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de Ciencias Empresariales y Sociales, Buenos Aires, Argentina, University of Vienna, University of Bergen, Universidad Nacional de Entre Rios, Kinn Municipality, Norway, Oslo Municipality, Norwegian Association for Music Therapy, Oslo Dementia Association
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611878
- Sponsor's protocol ID
- 106684
- Other IDs
- 344215
- Acronym
- M4M
- Status last verified
- Jan 2026
- First submitted
- 5 Sep 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Scripting and statistical analysis of baseline and outcome data will be followed by reporting of outcomes in publications and sharing of de-identified individual participant data and analysis code in a public repository.
Publications
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.
PubMed 41120149
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Memory for Music: Effects of Individual Intensive Musical Training Based on Singing in Non-musicians With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06611878
- Acronym / sponsor ID
- M4M / 106684
- Conditions
- Alzheimer Disease
- Keywords
- music and memory, N400, music-based intervention, music therapy, dementia, cognition, mood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- NORCE Norwegian Research Centre ASUniversity, hospital or other
- Collaborators
- Universidad de Ciencias Empresariales y Sociales, Buenos Aires, Argentina, University of Vienna, University of Bergen, Universidad Nacional de Entre Rios, Kinn Municipality, Norway, Oslo Municipality, Norwegian Association for Music Therapy, Oslo Dementia Association
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised crossover design
| Arm | Type | Receives |
|---|---|---|
| Intensive followed by minimal music training | Experimental | Behavioral: Music training - intensive, Behavioral: Music training - minimal, Other: Treatment as Usual (TAU)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). |
| Minimal followed by intensive music training | Experimental | Behavioral: Music training - intensive, Behavioral: Music training - minimal, Other: Treatment as Usual (TAU)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). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Alzheimer's disease
- Home-dwelling
- Non-musician
Key exclusion criteria (3 listed)
- Non-Alzheimer dementia
- Living in care home
- History as a professional musician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music training - intensiveMusic 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. | Behavioural | Intensive followed by minimal music training, Minimal followed by intensive music training |
| Music training - minimalMusic 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. | Behavioural | Intensive followed by minimal music training, Minimal followed by intensive music training |
| Treatment as Usual (TAU)Medications, behavioural interventions and other treatments that participants may receive outside the study during the period of participation. | Other | Intensive followed by minimal music training, Minimal followed by intensive music training |
Primary outcome
ADAS-cog
Time frame: 0, 5, 7, 12 months
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
Time frame: 0, 5, 7, 12 months
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.
8 secondary outcomes
Mood
Time frame: Beginning and end of each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.
Sense of Familiarity with current song (Instructor)
Time frame: During each training session, i.e. min. 1x/month, max. 10x/month, during months 1-5 and 7-12.
Sense of Familiarity with current song (External Evaluator)
Time frame: 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.
Performance (chorus solo)
Time frame: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
Performance (chorus in context)
Time frame: During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
Adverse events
Time frame: 5, 7, 12 months
Structural brain characteristics
Time frame: 0, 5 months
Functional brain connectivity metrics
Time frame: 0, 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 41120149Lichtensztejn 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.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Scripting and statistical analysis of baseline and outcome data will be followed by reporting of outcomes in publications and sharing of de-identified individual participant data and analysis code in a public repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music training - intensive, Music training - minimal and Treatment as Usual (TAU) in people with Alzheimer Disease, run by NORCE Norwegian Research Centre AS at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Norway, Argentina, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elias Langeland (0047 90628887, elil@norceresearch.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADAS-cog (time frame: 0, 5, 7, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.