Matziorinis A M, Flo B K, Skouras S, Dahle K, Henriksen A, Hausmann F, Sudmann T T, Gold C, Koelsch S
Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.
Kompetansesenter for Demens, Bergen Kommune, Norway.
Pilot Feasibility Stud. 2023 Apr 19;9(1):61. doi: 10.1186/s40814-023-01287-1.
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.
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.
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.
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.
Norsk Forskningsråd (NFR) funded. Regional Committees for Medical and Health Research Ethics (REC-WEST: reference number 2018/206).
gov: NCT03444181 (registered retrospectively 23 February 2018, https://clinicaltrials.gov/ct2/show/NCT03444181 ).
阿尔茨海默病与音乐疗法（ALMUTH）研究是首个采用随机对照试验（RCT）设计、对阿尔茨海默病（AD）患者进行为期12个月的积极非药物治疗（NPT）的研究，该治疗采用音乐疗法（MT）和体育活动（PA）。本文的目的是回顾性研究轻度至中度阿尔茨海默病患者纳入主要ALMUTH研究方案的情况，并确定是否有必要继续纳入AD患者。
随机试点试验作为一项平行三臂RCT进行，反映了ALMUTH研究的实验设计。该试验在挪威卑尔根进行，由一名外部研究人员进行随机分组（1:1:1）。该研究为开放标签试验，实验设计包括两种积极的NPT：MT和PA，以及对仍居住在家中且能够提供知情同意的挪威语AD患者进行的被动对照（无干预，CON）。每周提供一次治疗（最长90分钟），在12个月内最多进行40次治疗。基线和随访测试包括一套完整的神经心理学测试组和三次磁共振成像（MRI）测量（结构、功能和扩散加权成像）。评估可行性结果，若符合目标标准则判定为可行。
18名诊断为轻度至中度AD的参与者接受了筛查、随机分组，并在基线时测试一次，12个月后再测试一次。参与者分为三组：MT组（n = 6）、PA组（n = 6）和CON组（n = 6）。研究结果显示，AD患者的ALMUTH方案不可行。对研究方案的依从性较差（50%的人参加了治疗），损耗率和保留率均为50%。招募成本高昂，难以招募到符合纳入标准的参与者。更新研究方案时考虑了研究保真度问题和工作人员提出的问题。患者或其护理人员未报告不良事件。
该试点试验对轻度至中度AD患者不可行。为缓解这一情况，ALMUTH研究扩大了招募标准，除扩大神经心理学测试组外，还纳入了记忆障碍较轻形式（AD前期）的参与者。ALMUTH研究目前正在进行，直至2023年。
由挪威研究理事会（NFR）资助。西部医学和健康研究伦理区域委员会（REC-WEST：参考编号2018/206）。
gov：NCT03444181（于2018年2月23日追溯注册，https://clinicaltrials.gov/ct2/show/NCT03444181 ）
