Memory for Music: Individual Intensive Musical Training in Alzheimer's Disease
M4M
Memory for Music: Effects of Individual Intensive Musical Training Based on Singing in Non-musicians With Alzheimer's Disease
2 other identifiers
interventional
113
3 countries
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable alzheimer-disease
Started Dec 2024
Typical duration for not_applicable alzheimer-disease
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
December 10, 2024
December 1, 2024
2.8 years
September 5, 2024
December 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
0, 5, 7, 12 months
Secondary Outcomes (6)
Mood
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)
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)
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)
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)
During selected training sessions (last session of each month and when the instructor's rating changes), during months 1-5 and 7-12.
- +1 more secondary outcomes
Study Arms (2)
Intensive followed by minimal music training
EXPERIMENTALMusic 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
EXPERIMENTALMusic 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).
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- Diagnosis of Alzheimer's disease
- Home-dwelling
- Non-musician
You may not qualify if:
- Non-Alzheimer dementia
- Living in care home
- History as a professional musician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NORCE Norwegian Research Centre ASlead
- Universidad de Ciencias Empresariales y Sociales, Buenos Aires, Argentinacollaborator
- University of Viennacollaborator
- University of Bergencollaborator
- Universidad Nacional de Entre Rioscollaborator
- Kinn Municipality, Norwaycollaborator
- Oslo Municipalitycollaborator
- Norwegian Association for Music Therapycollaborator
- Oslo Dementia Associationcollaborator
Study Sites (6)
Universidad de Ciencias Empresariales y Sociales
Buenos Aires, Argentina
University of Vienna
Vienna, Austria
University of Bergen
Bergen, Vestland, 5020, Norway
Haraldsplass Diakonale Sykehus
Bergen, Vestland, 5892, Norway
Kinn municipality
Florø, Norway
Oslo municipality
Oslo, Norway
Related Publications (1)
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.
PMID: 41120149DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participants and instructors cannot be blinded due to the nature of the intervention. External evaluators will remain blinded after randomization; success of blinding will be verified at the end of each participant's participation.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2024
First Posted
September 25, 2024
Study Start
December 1, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2027
Last Updated
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Upon publication of results; unlimited.
- Access Criteria
- Open
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.