A 12-month randomised pilot trial of the Alzheimer’s and music therapy study: a feasibility assessment of music therapy and physical activity in patients with mild-to-moderate Alzheimer’s disease

Background: The Alzheimer’s and Music Therapy (ALMUTH) study is the first randomised controlled trial (RCT) design with 12 months of active non-pharmacological therapy (NPT) implementing music therapy (MT) and physical activity (PA) for participants with Alzheimer’s disease (AD). The aim of the present article is to retrospectively examine the inclusion of mild-to-moderate Alzheimer’s Disease patients into the main ALMUTH study protocol and to determine if continued inclusion of AD patients is warranted. Methods: The randomised pilot trial was conducted as a parallel three-arm RCT, reflecting the experimental design of the ALMUTH study. The trial was conducted in Bergen, Norway, and randomisation (1:1:1) was performed by an external researcher. The study was open label and the experimental design features two active NPTs: MT and PA, and a passive control (no intervention, CON) in Norwegian speaking patients with AD who still live at home and could provide informed consent. Sessions were offered once per week (up to 90 min) up to 40 sessions over 12 months. Baseline and follow-up tests included a full neuropsychological test battery and three magnetic resonance imaging (MRI) measurements (structural, functional, and diffusion weighted imaging). Feasibility outcomes were assessed and were determined as feasible if they met the target criteria. Results: Eighteen participants with a diagnosis of mild-to-moderate AD were screened, randomised, and tested once at baseline and once after 12-months. Participants were divided into three groups: MT (n = 6), PA (n = 6), and CON (n = 6). Results of the study revealed that the ALMUTH protocol in patients with AD was not feasible. The adherence to the study protocol was poor (50% attended sessions), with attrition and retention rates at 50%. The recruitment was costly and there were difficulties acquiring participants who met the inclusion criteria. Issues with study fidelity and problems raised by staff were taken into consideration for the updated study protocol. No adverse events were reported by the patients or their caregivers. Conclusions: The pilot trial was not deemed feasible in patients with mild-to-moderate AD. To mitigate this, the ALMUTH study has expanded the recruitment criteria to include participants with milder forms of memory impairment (pre-AD) in addition to expanding the neuropsychological test battery. The ALMUTH study is currently ongoing through 2023. Trial registration: Norsk Forskningsråd (NFR) funded. Regional Committees for Medical and Health Research Ethics (REC-WEST: reference number 2018/206). ClinicalTrials.gov: NCT03444181 (registered retrospectively 23 February 2018, https://clinicaltrials.gov/ct2/show/NCT03444181).