Research Center for Nursing Theory and Practice, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No.134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.
Department of Nursing, Fujian Provincial Hospital, Shengli Clinical Medical College of Fujian Medical University, No.134 Dongjie Street, Gulou district, Fuzhou, 350001, Fujian Province, China.
BMC Geriatr. 2022 Apr 7;22(1):296. doi: 10.1186/s12877-022-02961-4.
Given the aging population worldwide and the COVID-19 pandemic, which has been found to be associated with a deterioration in Alzheimer's disease (AD) symptoms, investigating methods to prevent or delay cognitive decline in preclinical AD and AD itself is important. The trial described in this protocol aims to evaluate the effects of a staged integral art-based cognitive intervention (SIACI) in older adults with CIs (preclinical AD [SCD or MCI] and mild AD), in order to gather evidence on the effects of SIACI on cognition and psychological/psychosocial health gains and determine the mechanisms.
The planned study is a single-center, parallel-arm, randomized controlled trial with allocation concealment and outcome assessor blinding. A total of 88 participants will be randomized to two groups: (i) an intervention group that receives the 16-week, 24-session SIACI program and (ii) a waitlist control group (which will receive the SIACI program after completing the follow-up assessment). Global cognitive function, specific domains of cognition (memory, language, executive function, and visuospatial skills), and other health-related outcomes (quality of life, anxiety, depression, sleep quality, and physical activity level) will be measured at baseline, immediately after the intervention, and at the 6-month follow-up. Blood biomarkers, event-related potential (ERP)-P300, and magnetic resonance imaging (MRI) data will be collected at baseline and immediately after the intervention to explore the mechanisms of SIACI.
The trial will elucidate the immediate and long-term effects of SIACI based on neuropsychological testing and blood biomarkers, and neuroscience involving ERP-P300 and MRI parameters will make it possible to explore the mechanisms of SIACI in older adults with CIs. The results will provide evidence on the effectiveness of an AT-based cognitive intervention, which may delay or even halt cognitive decline in preclinical AD and AD itself.
ChiCTR, ChiCTR2100044959 . Registered 03 April 2021.
鉴于全球人口老龄化以及 COVID-19 大流行，后者被发现与阿尔茨海默病（AD）症状恶化有关，因此研究预防或延缓临床前 AD 和 AD 本身认知能力下降的方法非常重要。本试验旨在评估分阶段整体艺术认知干预（SIACI）对认知障碍（临床前 AD [SCD 或 MCI]和轻度 AD）老年人的影响，以收集有关 SIACI 对认知和心理/社会心理健康收益影响的证据，并确定其机制。
该研究计划是一项单中心、平行臂、随机对照试验，采用分配隐藏和结局评估者盲法。共有 88 名参与者将随机分为两组：（i）干预组接受 16 周 24 节 SIACI 方案，（ii）候补对照组（完成随访评估后将接受 SIACI 方案）。在基线、干预结束后和 6 个月随访时，将测量总体认知功能、特定认知领域（记忆、语言、执行功能和视空间技能）以及其他健康相关结果（生活质量、焦虑、抑郁、睡眠质量和身体活动水平）。在基线和干预结束后收集血液生物标志物、事件相关电位（ERP）-P300 和磁共振成像（MRI）数据，以探索 SIACI 的机制。
该试验将基于神经心理学测试和血液生物标志物阐明 SIACI 的即时和长期效果，涉及 ERP-P300 和 MRI 参数的神经科学将有可能探索 SIACI 在认知障碍老年人中的机制。结果将提供基于 AT 的认知干预有效性的证据，这可能延缓甚至阻止临床前 AD 和 AD 本身的认知能力下降。
ChiCTR，ChiCTR2100044959。注册于 2021 年 4 月 3 日。
