基于游戏的认知训练能否减缓与阿尔茨海默病相关的认知能力下降？一项随机对照试验的方案。
Can a serious game-based cognitive training attenuate cognitive decline related to Alzheimer's disease? Protocol for a randomized controlled trial.
机构信息
University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.
Swiss Institute for Translational and Entrepreneurial Medicine, Bern, Switzerland.
出版信息
BMC Psychiatry. 2022 Aug 12;22(1):552. doi: 10.1186/s12888-022-04131-7.
BACKGROUND
Alzheimer's disease (AD) is a major public health issue. Cognitive interventions such as computerized cognitive trainings (CCT) are effective in attenuating cognitive decline in AD. However, in those at risk of dementia related to AD, results are heterogeneous. Efficacy and feasibility of CCT needs to be explored in depth. Moreover, underlying mechanisms of CCT effects on the three cognitive domains typically affected by AD (episodic memory, semantic memory and spatial abilities) remain poorly understood.
METHODS
In this bi-centric, randomized controlled trial (RCT) with parallel groups, participants (planned N = 162, aged 60-85 years) at risk for AD and with at least subjective cognitive decline will be randomized to one of three groups. We will compare serious game-based CCT against a passive wait list control condition and an active control condition (watching documentaries). Training will consist of daily at-home sessions for 10 weeks (50 sessions) and weekly on-site group meetings. Subsequently, the CCT group will continue at-home training for an additional twenty-weeks including monthly on-site booster sessions. Investigators conducting the cognitive assessments will be blinded. Group leaders will be aware of participants' group allocations. Primarily, we will evaluate change using a compound value derived from the comprehensive cognitive assessment for each of three cognitive domains. Secondary, longitudinal functional and structural magnetic resonance imaging (MRI) and evaluation of blood-based biomarkers will serve to investigate neuronal underpinnings of expected training benefits.
DISCUSSION
The present study will address several shortcomings of previous CCT studies. This entails a comparison of serious game-based CCT with both a passive and an active control condition while including social elements crucial for training success and adherence, the combination of at-home and on-site training, inclusion of booster sessions and assessment of physiological markers. Study outcomes will provide information on feasibility and efficacy of serious game-based CCT in older adults at risk for AD and will potentially generalize to treatment guidelines. Moreover, we set out to investigate physiological underpinnings of CCT induced neuronal changes to form the grounds for future individually tailored interventions and neuro-biologically informed trainings.
TRIAL REGISTRATION
This RCT was registered 1st of July 2020 at clinicaltrials.gov (Identifier NCT04452864).
背景
阿尔茨海默病（AD）是一个主要的公共卫生问题。认知干预措施，如计算机化认知训练（CCT），可有效减缓 AD 患者的认知能力下降。然而，对于那些有 AD 相关痴呆风险的患者，结果存在异质性。需要深入探索 CCT 的疗效和可行性。此外，CCT 对 AD 通常影响的三个认知领域（情景记忆、语义记忆和空间能力）的作用机制仍知之甚少。
方法
这是一项在两个中心进行的、平行组的随机对照试验（RCT），纳入了有 AD 风险且至少有主观认知下降的参与者（计划纳入 162 名，年龄 60-85 岁），他们将被随机分配到三组之一。我们将比较基于严肃游戏的 CCT 与被动等待对照条件和主动对照条件（观看纪录片）。训练将包括 10 周（50 次）的每日家庭课程和每周一次的现场小组会议。随后，CCT 组将继续在家中进行另外 20 周的训练，包括每月的现场强化课程。进行认知评估的研究人员将被设盲。组长将了解参与者的分组情况。主要评估方法是使用每个认知领域综合认知评估得出的复合值来评估变化。其次，纵向功能和结构磁共振成像（MRI）以及血液生物标志物的评估将用于研究预期训练效益的神经元基础。
讨论
本研究将解决以前 CCT 研究的几个缺陷。这包括将基于严肃游戏的 CCT 与被动和主动对照条件进行比较，同时纳入对训练成功和依从性至关重要的社会元素，将家庭和现场训练相结合，包括强化课程，并评估生理标志物。研究结果将提供有关针对有 AD 风险的老年人进行基于严肃游戏的 CCT 的可行性和疗效的信息，并可能推广到治疗指南。此外，我们着手研究 CCT 诱导的神经元变化的生理基础，为未来的个体化干预措施和神经生物学指导的训练奠定基础。
试验注册
这项 RCT 于 2020 年 7 月 1 日在 clinicaltrials.gov（标识符 NCT04452864）注册。
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