Evaluation of a novel computer-based test for early detection of Alzheimer's

描述（由申请人提供）：阿尔茨海默病目前影响着估计540万美国人，预计这一数字将在未来十年显着增长。阿尔茨海默病研究的一个关键和最终目标是改善早期诊断方法，以便患者能够更快地被识别，从而从现有治疗中获得更大的优势。第二个关键和更直接的目标是开发更好的方法来检测处于风险中或已经处于阿尔茨海默氏症轨道上但尚未出现临床症状的个体，以便制药公司和研究人员可以用合适的个体填充他们的临床试验。缺乏早期标记物或即将发生的疾病的预测因子是开发可能治疗甚至治愈阿尔茨海默病的新药的能力的重大障碍。Neurotrack Technologies，Inc.是一家位于加利福尼亚州帕洛阿尔托的初创公司，围绕一套行为和软件技术形成，旨在促进在家中和临床环境中检测和预测阿尔茨海默氏症。Neurotrack的核心是一种行为分析，它使用眼球跟踪技术沿着数据分析算法来评估识别记忆。它是基于埃默里大学的科学家和医生对非人类灵长类动物和人类健忘症患者进行的数十年研究，他们开发了一种对记忆障碍高度敏感的行为任务，并且在阿尔茨海默病的早期诊断和临床症状发生前几年预测阿尔茨海默病发作的能力方面都表现出了希望。我们的行为测试评估识别记忆，这是一种严重依赖于大脑海马区完整性的记忆形式，海马区是阿尔茨海默氏症过程中最先发生形态变化的区域之一。我们发表的5年NIH资助的纵向研究结果显示，这项测试的表现在预测认知能力下降方面非常准确。Neurotrack的技术有可能为制药公司和研究机构提供所需的工具，以招募真正合适的候选人进行临床试验，并更有效地衡量药物疗效，加快药物发现和开发。该提案包括三个目标：1）开发和优化用于执行我们的测试的商业原型，2）对一小群患者进行Beta测试并完善该原型，以及3）进行初步可行性研究，将我们的新商业版本进行比较测试与研究人员和临床医生目前可用的已建立的预测分析。这些改进将推动该技术成为可行的第一代商业原型，为大型多地点临床试验做准备。

DESCRIPTION (provided by applicant): Alzheimer's disease currently affects an estimated 5.4 million Americans, and this number is expected to grow significantly in the coming decade. A critical and ultimate goal of Alzheimer's disease research is to improve methods of early diagnosis, so that patients can be identified sooner and, therefore, obtain greater advantage from available therapies. A second critical and more immediate goal is to develop better ways to detect individuals who are at risk or who are already on the trajectory for Alzheimer's but have not yet developed clinical symptoms, so that pharmaceutical companies and researchers can populate their clinical trials with appropriate individuals. A lack of early markers or predictors f impending disease represents a significant roadblock in the ability to develop new drugs that might treat or even cure Alzheimer's disease. Neurotrack Technologies, Inc. is a Palo Alto CA-based startup formed around a suite of behavioral and software technologies designed to facilitate the detection and prediction of Alzheimer's both at home and in the clinical setting. Th centerpiece of Neurotrack is a behavioral assay that uses eye-tracking technology along with data analysis algorithms to assess recognition memory. It is based on decades of research in nonhuman primates and in human amnesic patients by scientists and physicians at Emory University, who have developed a behavioral task that is highly sensitive to memory impairment and which has shown promise both in the early diagnosis of Alzheimer's disease and in the ability to predict the onset of Alzheimer's disease several years before clinical symptoms occur. Our behavioral test assesses recognition memory, a form of memory that critically depends on the integrity of the hippocampal region of the brain, one of the first areas to undergo morphological change in the course of Alzheimer's. Published results from our 5-year NIH-funded longitudinal study revealed that performance on this test was highly accurate in predicting cognitive decline. Neurotrack's technology has the potential to give pharmaceutical companies and research organizations the tools they need to recruit truly appropriate candidates for clinical trials and more effectively measure drug efficacy, speeding up drug discovery and development. This proposal consists of three aims: 1) to develop and optimize a commercial prototype for administering our test, 2) to beta test and refine this prototype with a small group of patients, and 3) to conduct an initial feasibility study comparing our new commercial version of the test to the established predictive assays currently available to researchers and clinicians. These improvements will advance the technology into a viable first generation commercial prototype in preparation for a large, multi-site clinical trial.