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

评估一种基于计算机的新型阿尔茨海默病早期检测测试

• 批准号: 8715505
• 负责人: MICHAEL NMN DAVIS
• 金额: $ 22.53万
• 依托单位: NEUROTRACK TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-15 至 2017-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8715505
• 关键词: Address; Affect; Algorithms; Alzheimer disease detection; Alzheimer' s Disease; American; Area; Behavioral; Behavioral Assay; Biological Assay; Brain region; Cerebrospinal Fluid; Clinical; Clinical Trials; Cognitive; Computer software; Computers; Data Analyses; Detection; Development; Diagnosis; Diagnostic; Disease; Disease Progression; Early Diagnosis; Elderly; Enrollment; Ensure; Evaluation; Eye; Feasibility Studies; Focus Groups; Funding; Generations; Goals; Hippocampus (Brain); Home environment; Human; Impaired cognition; Individual; Investigation; Licensing; Longitudinal Studies; Measures; Memory; Memory impairment; Methods; Metric; Multi-Institutional Clinical Trial; Nervous system structure; Onset of illness; Paired Comparison; Paper; Patient Recruitments; Patients; Performance; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Physicians; Population; Preparation; Process; Publishing; Recommendation; Recruitment Activity; Relative (related person); Reporting; Research; Research Infrastructure; Research Personnel; Risk; Scientist; Small Business Innovation Research Grant; Solutions; Speed; Staging; Symptoms; System; Technology; Testing; Therapeutic; Time; United States National Institutes of Health; Universities; Visual; base; behavior test; clinical Diagnosis; clinical research site; computerized; data management; design; drug development; drug discovery; drug efficacy; healthy aging; impression; improved; innovation; laptop; meetings; memory recognition; mild cognitive impairment; neuroimaging; nonhuman primate; novel; prototype; public health relevance; tool; usability; visual performance

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.

描述（由申请人提供）：阿尔茨海默氏病目前影响约540万美国人，预计在未来十年中，这一数字将大幅增长。阿尔茨海默氏病研究的一个关键和最终目标是改善早期诊断方法，以便可以更快地确定患者，因此可以从可用的疗法中获得更大的优势。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危险的人或已经处于阿尔茨海默氏症轨迹上但尚未出现临床症状的人，以便制药公司和研究人员可以与适当的人一起填充其临床试验。 。缺乏早期标记或预测因素F即将到来的疾病是开发可能治疗甚至治愈阿尔茨海默氏病的新药能力的重大障碍。 Neurotrack Technologies，Inc。是一家基于Palo Alto CA的创业公司，围绕一套行为和软件技术，旨在促进对阿尔茨海默氏症的检测和预测在家中和临床环境中的检测和预测。 Neurotrack的核心是一种行为测定，它使用眼球跟踪技术以及数据分析算法来评估识别记忆。它是基于埃默里大学（Emory University）的科学家和医生在非人类灵长类动物和人类失忆患者中进行的数十年研究，他们制定了一项对记忆障碍高度敏感的行为任务，并且在早期诊断阿尔茨海默氏病的早期诊断中都表现出了希望。为了预测临床症状前几年的阿尔茨海默氏病发作。我们的行为测试评估了识别记忆，这是一种严重取决于大脑海马区域的完整性的一种记忆形式，这是最早在阿尔茨海默氏病过程中发生形态学变化的领域之一。我们5年的NIH资助纵向研究发表的结果表明，该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组织提供招募真正合适的临床试验候选者所需的工具，并更有效地衡量药物疗效，从而加快药物发现和开发。该提案包括三个目的：1）开发和优化用于管理我们的测试的商业原型，2）beta测试并与一小部分患者完善该原型，以及3）进行初始可行性研究，以比较我们的新商业研究人员和临床医生目前可以使用的既定预测测定法。这些改进将把技术推向可行的第一代商业原型，为大型多站点临床试验做准备。