What is the research project about?
Memory for Music (M4M) is a research project evaluating the effects of musical training on cognitive abilities in home-dwelling non-musicians with Alzheimer's disease.
It is designed to provide strong evidence of clinical effects and brain mechanisms involved in music-making, and will contribute to a better understanding of Alzheimer's disease and neuroplasticity.
For more information on the BACKGROUND, METHOD, IMPACT and WORK PACKAGES of the project, see further below.
Project information
Project start: August 2024
Participant recruitment scheduled to start in October 2024.
Trial registration:
at clinicaltrials.gov: [number & link will be added once available]
International project team
M4M is a randomised controlled trial conducted in Norway and Argentina. It is led by NORCE Norwegian Research Centre (PI Christian Gold) and conducted in collaboration with the University of Bergen, the University of Business and Social Sciences, Buenos Aires, the University of Vienna, and societal partners in Norway.
See the country-specific pages for more information about the Norwegian project team, the Argentinian project team, and the Austrian project team.
Monitoring Committee
The role of the DSMC is to safeguard the interests of trial participants, assess the safety of the interventions during the trial, and monitor the overall conduct of the clinical trial. The DSMC will monitor data quality, safety, ethical aspects, and that the study can be conducted sufficiently in terms of recruitment, data collection, problems at participating sites, differences between the groups, and missing data.
The independent DSMC consists of people with strong methodological and clinical expertise who are not otherwise affiliated with the project or its institutions:
- Teppo Särkämö (chair; Faculty of Medicine, University of Helsinki, Finland)
- Sytse U. Zuidema (Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, the Netherlands)
- Paul Bassett (freelance statistician and owner of Statsconsultancy Ltd near London, UK)
The DSMC has unblinded access to study data and will receive regular updates on recruitment, uptake of interventions, unforeseen events, adverse events, and immediate information on serious adverse events from the trial statistician (Jörg Assmus). Meetings with the DSMC are held on a biannual basis and consist of an open and a closed part. If issues arise, the DSMC will recommend to the PI on appropriate action.
People with dementia...
tend to have a well-preserved memory for songs learned earlier in life. In M4M, researchers will examine whether musical semantic memory for newly learned songs ("memory for music") can be developed in people with Alzheimer's.
Background
The number of people living with dementia is increasing worldwide. Alzheimerʼs 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.
Method
Home-dwelling adults with AD, 65 years or older, in 2-3 countries (confirmed: Argentina, Norway; pending funding: Austria), 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.
We aim to include about 120 participants; this will help us to reliably detect clinically meaningful effects. We 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.
Impact
Impacts of M4M will include improved knowledge on the effects, mechanisms, and feasibility of a novel intervention to improve memory and overall cognitive functioning. Findings gained from M4M will have implications for evidence-based treatment planning, with the potential of improving the quality of life of people with Alzheimerʼs disease. Findings will be relevant across several societies (urban and rural settings; high- and middle-income countries) and can be adapted and replicated in different parts of the world to design culturally sensitive approaches for this population.
Work packages
WP1: Trial design, randomisation, trial registration
WP2: Recruitment of study sites and participants:
WP3: Interventions
WP4: General cognition outcomes
WP5: Memory for music
WP6: Adverse events
WP7: Additional measures, extensions
WP8: Sample size and power, data monitoring, statistical analysis