The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer's Disease (TRC-PAD): Experience from the First 3 Years.
The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer's Disease (TRC-PAD): Experience from the First 3 Years.
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DOI：
10.14283/jpad.2020.47
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发表时间：
2020
影响因子：
--
通讯作者：
Aisen PS
中科院分区：
文献类型：
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作者：
Walter S;Langford OG;Clanton TB;Jimenez-Maggiora GA;Raman R;Rafii MS;Shaffer EJ;Sperling RA;Cummings JL;Aisen PS
临床前和前驱阿尔茨海默病的试验就绪队列（TRC-PAD）旨在通过远程识别和跟踪患有AD症状的高风险个体来加速阿尔茨海默病（AD）临床试验的招募，并将这些个体转介给面对面的认知和生物标志物评估，目的是让他们参与临床试验。随着TRC-PAD随着数据集的成熟而不断发展，使用统计建模预测脑淀粉样变性的风险算法将得到完善。总结建立该试验就绪队列（TRC）所采取的步骤，并分享入组该项目前3年的结果。参与者被远程招募到阿尔茨海默病预防试验（APT）网络研究中，进行季度评估，并通过一种算法被确定为潜在的高风险，被转介到临床研究中心进行生物标志物确认，并被招募到TRC中。在线研究和诊所内非干预性队列研究。APT网络研究参与者年龄在50岁或以上，有兴趣参与AD治疗试验。TRC参与者必须有一个研究伙伴，稳定的医疗条件，和升高的脑淀粉样蛋白，如淀粉样蛋白正电子发射断层扫描或脑脊液分析测量。其他风险评估包括载脂蛋白E基因分型。在APT网络研究中，参与者完成认知功能指数和Cogstate Brief Battery。TRC包括临床前阿尔茨海默氏症认知综合征，包括自由和线索选择性提醒测试，韦氏记忆量表逻辑记忆IIa测试的延迟段落回忆评分，韦氏成人智力量表修订版的数字符号替代测试，以及简易精神状态检查总分。在该项目的前3年，APT网络研究有30，650名知情同意的受试者，其中23家研究中心批准进行亲自筛选，112名受试者被转诊进行诊所内筛选访视，其中18名入组TRC。大多数同意APT网络研究的参与者有AD家族史（62%），确定为白人（92.5%），接受过12年以上的正规教育（85%），并且是女性（73%）。第一季度评估的随访率为38.2%，29.5%完成了Cogstate电池的随访。在成功设计和实施该计划后，研究团队的首要任务是提高APT网络研究和TRC参与者的多样性，继续招募TRC，达到我们2,000人的目标，并提高纵向保留率，同时开始将TRC参与者纳入临床试验的过程。
The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s disease (TRC-PAD) aims to accelerate enrollment for Alzheimer’s disease (AD) clinical trials by remotely identifying and tracking individuals who are at high risk for developing symptoms of AD, and referring these individuals to in-person cognitive and biomarker evaluation with the purpose of engaging them in clinical trials. A risk algorithm using statistical modeling to predict brain amyloidosis will be refined as TRC-PAD advances with a maturing data set. To provide a summary of the steps taken to build this Trial-Ready cohort (TRC) and share results of the first 3 years of enrollment into the program. Participants are remotely enrolled in the Alzheimer Prevention Trials (APT) Webstudy with quarterly assessments, and through an algorithm identified as potentially at high risk, referred to clinical sites for biomarker confirmation, and enrolled into the TRC. Both an online study and in-clinic non-interventional cohort study. APT Webstudy participants are aged 50 or older, with an interest in participation in AD therapeutic trials. TRC participants must have a study partner, stable medical condition, and elevated brain amyloid, as measured by amyloid positron emission tomography or cerebrospinal fluid analysis. Additional risk assessments include apolipoprotein E genotyping. In the APT Webstudy, participants complete the Cognitive Function Index and Cogstate Brief Battery. The TRC includes the Preclinical Alzheimer’s Cognitive Composite, comprised of the Free and Cued Selective Reminding Test, the Delayed Paragraph Recall score on the Logical Memory IIa test from the Wechsler Memory Scale, the Digit-Symbol Substitution test from the Wechsler Adult Intelligence Scale-Revised, and the Mini Mental State Examination total score. During the first 3 years of this program, the APT Webstudy has 30,650 consented participants, with 23 sites approved for in person screening, 112 participants have been referred for in-clinic screening visits with eighteen enrolled to the TRC. The majority of participants consented to APT Webstudy have a family history of AD (62%), identify as Caucasian (92.5%), have over twelve years of formal education (85%), and are women (73%). Follow up rates for the first quarterly assessment were 38.2% with 29.5% completing the follow up Cogstate Battery. After successfully designing and implementing this program, the study team’s priority is to improve diversity of participants both in the APT Webstudy and TRC, to continue enrollment into the TRC to our target of 2,000, and to improve longitudinal retention, while beginning the process of referring TRC participants into clinical trials.