Innovating Tablet-Based Cognitive Assessment for CNS Disorders of Aging

 描述（由申请人提供）：老龄化人群已成为治疗药物开发人员的关键目标，特别是对于影响认知功能的适应症。阿尔茨海默病和血管性痴呆等疾病影响美国老年人的生活质量，主要是由于它们对认知功能的影响，治疗选择不足。最近的报告表明，早期识别有风险的个体可能有助于减缓认知能力下降的进展和发作。因此，迫切需要新的认知测试，能够筛查患者与神经退行性疾病的早期阶段相关的轻度或中度认知下降。诸如ADAS-Cog（阿尔茨海默病评估量表-认知子量表）的测试对较轻度形式的认知障碍缺乏敏感性，并且管理和评分繁琐且耗时。有效的认知障碍筛查测试必须简短，易于管理，并自动评分。这些测试必须针对老龄化人群量身定制，并证明对轻度认知能力下降的敏感性。为了让个人的表现有意义的解释，良好的动力，人口统计学为目标的规范性研究是必不可少的。“纸笔”测试仍然是评估认知能力下降的主要标准。最近开发的一些计算机化测试表明，在大多数人口群体中，使用方便、数据可靠性和成本效益都有所提高。然而，在老龄化人口中，计算机测试的表现通常与纸笔测试的表现相关性很差，这使得人们对计算机测试收集的数据在该人群中的有效性提出了质疑。由NeuroCog Trials开发的认知简要评估（BAC）测试组合已用于一系列与认知障碍相关的研究，最近已被改编为计算机化测试，BAC App，通过iPad（r）进行管理。在我们公司资助的“第一阶段报告”中，我们提供了有关BAC App开发的详细信息，以及来自我们验证研究的数据，这些数据显示了笔和纸BAC的性能与老年人BAC App的性能之间的强相关性。这些数据非常令人鼓舞，我们建议扩大BAC应用程序中包含的测试数量。这将使人们对情景记忆和空间工作记忆的缺陷更加敏感，这是认知能力下降的最早迹象之一，特别是在阿尔茨海默氏症中。我们的第二阶段计划将专注于将这些新的测试整合到BAC App中，与Kathleen Welsh-Bohmer博士（杜克大学）合作在老年人中进行一项强有力的规范性数据研究，并确定BAC App区分健康受试者和认知能力下降受试者的能力。第二阶段计划的成功完成将使NeuroCog Trials能够在针对老龄化人群的认知衰退研究中提供BAC App，这一需求反映在文献和NeuroCog客户的最新反馈中。

 DESCRIPTION (provided by applicant): Aging populations have become a key target for therapeutics developers, particularly for indications impacting cognitive function. Conditions such as Alzheimer's disease and vascular dementia affect the quality of life of aging Americans, largely due to their impact on cognitive function, with insufficient therapeutic options. Recent reports indicate that early identification of at-risk individuals may help to slow progression and onset of cognitive decline. Thus, new cognitive tests, capable of screening patients for mild or moderate cognitive decline associated with the earliest stages of neurodegenerative disease, are urgently needed. Tests such as the ADAS-Cog (Alzheimer's Disease Assessment Scale - Cognitive subscale) lack sensitivity to milder forms of cognitive impairment, and are cumbersome and time-consuming to administer and score. Effective screening tests for cognitive impairment must be brief, simple to administer, and automatically scored. These tests must be tailored toward aging populations and demonstrate sensitivity to mild cognitive decline. In order to allow meaningful interpretation of individual's performance, well-powered, demographically-targeted normative studies are essential. "Pen and paper" testing remains largely the standard for the assessment of cognitive decline. Some recently developed computerized tests have demonstrated improvement in ease of use, data reliability and cost-effectiveness in most demographic groups. In the aging population, however, performance on computerized tests is often poorly correlated with performance on pen-and-paper tests, calling into question the validity of data collected with computerized tests in this population. The Brief Assessment of Cognition (BAC) test battery developed by NeuroCog Trials has been employed in a range of studies associated with cognitive impairment, and has recently been adapted as a computerized test, the BAC App, administered via iPad(r). In our company-funded "Phase I Report," we provide details regarding the development of the BAC App, as well as data from our validation study showing a strong correlation between performance on the pen-and-paper BAC and performance on the BAC App in aging adults. These data are extremely encouraging, and we propose to expand the number of tests included in the BAC App. This would allow for greater sensitivity to deficits in episodic memory and spatial working memory, which are among the earliest signs of cognitive decline, particularly in Alzheimer's. Our Phase II program will focus on integrating these new tests into the BAC App, conducting a well-powered normative data study in aging adults in collaboration with Dr. Kathleen Welsh-Bohmer (Duke University), and determining the ability of the BAC App to discern healthy subjects from those experiencing cognitive decline. Successful completion of the Phase II program will enable NeuroCog Trials to offer the BAC App in cognitive decline studies specific to aging populations, a need reflected in both the literature and recent feedback from NeuroCog's customers.