Prof. Bruno Vellas, Gérontopôle, Department of Geriatrics, CHU Toulouse, Purpan University Hospital, Toulouse, France,
J Prev Alzheimers Dis. 2018;5(1):31-35. doi: 10.14283/jpad.2017.21.
Defining the primary cognitive endpoint is a major decision for Alzheimer's disease preventive trials. As an example for further trials we present in detail the three-year cognitive decline in the placebo group of MAPT trial, a randomized controlled trial (RCT) using a cognitive composite score (MAPT-PACC). Participants were dementia-free adults 70 years or older, with subjective memory complaints. Our findings as expected showed subjects with older age (>75), higher beta amyloid brain deposition, APOE-ε4 allele carriers, with low RBC DHA+EPA levels and higher CDR level are at higher risk of cognitive decline. The data presented in this paper can be useful for future preventive trials to choose the primary cognitive end point, assess the clinical relevance of cognitive changes and perform sample size calculation for several targeted population eg. ApoE4, amyloid +, oldest old, lower n3-PUFA. We believe that the trial group with CDR 0.5, without being selected by a memory test endpoint is a good target population for AD preventive trials.
定义主要认知终点是阿尔茨海默病预防试验的一个主要决策。作为进一步试验的一个例子，我们详细介绍了 MAPT 试验安慰剂组的三年认知衰退情况，MAPT 试验是一项使用认知综合评分（MAPT-PACC）的随机对照试验（RCT）。参与者为无痴呆的 70 岁或以上、有主观记忆投诉的成年人。不出所料，我们的研究结果表明，年龄较大（>75 岁）、β淀粉样蛋白脑沉积较高、载有 APOE-ε4 等位基因、红细胞 DHA+EPA 水平较低和 CDR 水平较高的受试者认知衰退的风险更高。本文介绍的数据可用于未来的预防试验选择主要认知终点，评估认知变化的临床相关性，并针对特定人群（例如 ApoE4、淀粉样蛋白+、最年长、n3-PUFA 水平低）进行样本量计算。我们认为，CDR 为 0.5 的试验组，且未通过记忆测试终点选择，是 AD 预防试验的一个很好的目标人群。
