Forcano Laura, Fauria Karine, Soldevila-Domenech Natalia, Minguillón Carol, Lorenzo Thais, Cuenca-Royo Aida, Menezes-Cabral Sofia, Pizarro Nieves, Boronat Anna, Molinuevo José Luis, de la Torre Rafael
Integrative Pharmacology and Systems Neurosciences Research Group, Neurosciences Research Program Hospital del Mar Medical Research Institute (IMIM) Barcelona Spain.
CIBER de Fisiopatología de la Obesidad y la Nutrición (CIBEROBN) Instituto de Salud Carlos III Madrid Spain.
Alzheimers Dement (N Y). 2021 Mar 31;7(1):e12155. doi: 10.1002/trc2.12155. eCollection 2021.
INTRODUCTION: Subjects exhibiting subjective cognitive decline (SCD) are at an increased risk for mild cognitive impairment and dementia. Given the delay between risk exposure and disease onset, SCD individuals are increasingly considered a good target population for cost-effective lifestyle-based Alzheimer's disease prevention trials. METHODS: The PENSA study is a randomized, double-blind, controlled clinical trial that aims to evaluate the efficacy of a personalized multimodal intervention in lifestyle (diet counseling, physical activity, cognitive training, and social engagement) combined with the use of epigallocatechin gallate (EGCG) over 12 months, in slowing down cognitive decline and improving brain connectivity. The study population includes 200 individuals meeting SCD criteria and carrying the apolipoprotein E ε4 allele, who will be randomized into four treatment arms (multimodal intervention + EGCG/placebo, or lifestyle recommendations + EGCG/placebo). The primary efficacy outcome is change in the composite score for cognitive performance measured with the Alzheimer's Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC-like) adding to the original version the Interference score from the Stroop Color and Word Test and the Five Digit Test. Secondary efficacy outcomes are (1) change in functional magnetic resonance imaging (fMRI) and structural neuronal connectivity (structural MRI) and (2) the safety assessment of the EGCG compound. This study is framed within the WW-FINGERS consortium. DISCUSSION: The use of new technologies (i.e., mobile ecological momentary assessments [EMAs], activity tracker) in the PENSA study allows the collection of continuous data on lifestyle behaviors (diet and physical activity) and mood, enabling a personalized design as well as an intensive follow-up of participants. These data will be used to give feedback to participants about their own performance along the intervention, promoting their involvement and adherence. The results of the study may aid researchers on the design of future clinical trials involving preventive lifestyle multicomponent interventions.
引言：表现出主观认知衰退（SCD）的个体患轻度认知障碍和痴呆症的风险增加。鉴于风险暴露与疾病发作之间存在延迟，SCD个体越来越被视为基于生活方式的具有成本效益的阿尔茨海默病预防试验的良好目标人群。 方法：PENSA研究是一项随机、双盲、对照临床试验，旨在评估个性化多模式生活方式干预（饮食咨询、体育活动、认知训练和社交参与）联合使用表没食子儿茶素没食子酸酯（EGCG）12个月，在减缓认知衰退和改善脑连通性方面的疗效。研究人群包括200名符合SCD标准且携带载脂蛋白E ε4等位基因的个体，他们将被随机分为四个治疗组（多模式干预+EGCG/安慰剂，或生活方式建议+EGCG/安慰剂）。主要疗效指标是使用阿尔茨海默病协作研究临床前阿尔茨海默认知综合量表（ADCS-PACC样）测量的认知表现综合评分的变化，该量表在原始版本基础上增加了斯特鲁普颜色和文字测试的干扰分数以及五位数测试。次要疗效指标是（1）功能磁共振成像（fMRI）和结构神经元连通性（结构MRI）的变化，以及（2）EGCG化合物的安全性评估。本研究是在WW-FINGERS联盟框架内进行的。 讨论：PENSA研究中使用新技术（即移动生态瞬时评估[EMA]、活动追踪器）能够收集关于生活方式行为（饮食和体育活动）和情绪的连续数据，从而实现个性化设计以及对参与者的密集随访。这些数据将用于向参与者反馈他们在干预过程中的自身表现，促进他们的参与和依从性。该研究结果可能有助于研究人员设计未来涉及预防性生活方式多组分干预的临床试验。
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