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.

introductionThe number of people living with dementia is increasing worldwide. Alzheimer's disease (AD) is the most common type of dementia. It typically manifests itself initially with cognitive impairment in the memory domain and gradually progresses towards affecting all activities of daily living. Active music interventions, particularly singing, may improve mood, social behaviour and quality of life. However, little is known about their effects on cognition, although some studies have provided promising results. The Memory for Music (M4M) project aims to fill this gap in research by measuring the effects of learning new songs on cognitive functioning. Specifically, M4M will examine memory for new songs in non-musician adults with AD after undergoing intensive versus minimal individual musical training based on singing novel songs. METHODS AND ANALYSIS: Home-dwelling adults with AD, 65 years or older, will receive 5 months of intensive intervention (2×/week) and 5 months of minimal intervention (1×/month). In a crossover design, participants will be randomised to receive either the intensive or minimal intervention first, with 2 months between the intervention periods. Participants will receive individual music lessons to learn new songs, provided by a music instructor with adequate training. The main outcomes will be measured at the beginning and end of each intervention period. General cognition will be measured with the AD Assessment Scale - Cognitive by an assessor blinded to the randomisation. Participants' memory for music will be measured using the N400 component of electroencephalographic (EEG) event-related potentials in response to music stimuli. Additional outcomes evaluated during intervention sessions include mood and musical performance observations. With 113 participants randomised, the trial will have 80% power to detect clinically meaningful effects. Relations between mood, memory for music and cognitive abilities will be examined, with sex, age, AD stage, previous musical training and education as covariates. M4M will be conducted in close collaboration between academic researchers, service providers and service users to ensure relevance and applicability. ETHICS AND DISSEMINATION: Dissemination of findings will apply to local, national and international levels. The study has been approved by the Regional Committees for Medical and Health Research Ethics in Norway (reference number 759936) and by Mautalén Salud e Investigación, CECOM in Argentina (register code 14412). TRIAL REGISTRATION NUMBER: Clinicaltrials.gov, NCT06611878.