Development of a Remotely Deliverable Cognitive Assessment Sensitive to Early Stage Mild Cognitive Impairment.

开发对早期轻度认知障碍敏感的可远程交付的认知评估。

• 批准号: 10482236
• 负责人: Peter Kallestrup
• 金额: $ 125.2万
• 依托单位: I-FUNCTION, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-01 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482236
• 关键词: Aging; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer’s disease biomarker; Amyloid; Amyloid beta-42; Amyloid deposition; Atrophic; Biological Markers; Blood; Brain; Brain region; Businesses; Child; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Cognitive aging; Cognitive deficits; Communities; Computer software; Cues; Cultural Diversity; Data; Dementia; Detection; Development; Diagnostic tests; Early Diagnosis; Early Intervention; Elderly; Elements; Evaluation; Exhibits; Failure; Funding; General Population; Goals; Gold; Health; Health Professional; Impaired cognition; Individual; International; Late Onset Alzheimer Disease; Learning; Measures; Memory; Memory impairment; Methods; Neuropsychological Tests; Neuropsychology; Online Systems; Paper; Parents; Participant; Patients; Performance; Persons; Phase; Population; Positron-Emission Tomography; Prevention; Prevention trial; Property; Protein Structure Initiative; Psychometrics; Research; Research Personnel; Rest; Risk; Sampling; Sampling Studies; Self Administration; Semantics; Small Business Innovation Research Grant; Specificity; Speech Recognition Software; Standardization; Supervision; Syndrome; System; Testing; Training Programs; United States National Institutes of Health; Universities; Update; Work; age related; aging population; amnestic mild cognitive impairment; base; blood-based biomarker; cloud based; cognitive neuroscience; cognitive testing; commercialization; community setting; comparative; computerized; cost effective; design; diagnostic screening; digital; early screening; experience; functional decline; functional independence; instrument; middle age; mild cognitive impairment; minimally invasive; neuropathology; next generation; novel; prevent; prodromal Alzheimer' s disease; remote delivery; screening; skills; tau Proteins; tau-1; usability; user centered design; validation studies; β-amyloid burden

Abstract With the aging of the population, the risk for age-related conditions such as Alzheimer’s disease(AD) and its common precursor, MCI, is increasing. However, studies targeting prevention of MCI and AD have commonly failed and part of the reason may be failures in selection of a population that is still at risk and has not yet developed fully syndromal MCI. This project leverages our experience with novel semantic interference paradigms and proposes to develop a widely accessible version of the Loewenstein-Acevedo Scales for Semantic Interference and Learning (LASSI-L). As noted in the body of the application, the LASSI-L has shown significant promise for the early detection of pre-MCI, in both national and international studies including identification of individuals with evidence of amyloid deposition in the absence of detectable cognitive impairments with standard neuropsychological measures. A computerized version of the LASSI, the LASSI- Brief Computerized (LASSI-BC) version has been developed and validated on a preliminary basis in our NIH funded studies but requires significant refinement to make it applicable for commercial use. The goal of this phase II SBIR is to develop the next generation of semantic interference measures (LASSI-D), by making it feasible to remotely deliver and score, for both large-scale clinical trials screening and clinical use. Given the millions of individuals in the US and the rest of the world who are at risk for development of dementia, early intervention is critical and the availability of such as assessment strategy would broadly increase access to early screening and detection. The proposed Phase II SBIR is responsive to PAS-19-316, SBIR Phase II. In specific, this application is directly focused on development of: “Sensitive, specific, and standardized tests for diagnostic screening of mild cognitive impairment (MCI) and dementia, including the development of new, cost- effective, minimally-invasive biomarkers that could be used for screening in the general population and in community settings”. In this study we will evaluate whether the LASSI-D is also sensitive to the earliest phase of MCI as well as being related to blood-based amyloid and tau biomarkers. This system will be designed to be self- administered and hence to be widely useful for large- scale clinical trial screening in the general population and clinical use in community settings.Our company is conducting a phase II SBIR focused on a self-administered system for the treatment of functional deficits in MCI and the cloud-based platform for delivery ofthe functional skills assessment and training program (FUNSAT) will be used for the development of the LASSI-D. Our long-term goal is to develop a commercially successful suite of products that can help identify risk for, prevent, and treat cognitive and functional declines and maintain the cognitive health and functional independence of older adults. Commercialization efforts have begun for both FUNSAT and LASSI-L and we have commitments from several large-scale potential customers.

摘要 随着人口老龄化，与年龄相关的疾病如阿尔茨海默病（AD）及其 共同的前体MCI正在增加。然而，针对MCI和AD预防的研究通常 失败，部分原因可能是在选择仍然处于风险中的人群时失败， 发展成完全综合征型MCI这个项目利用了我们在新语义干扰方面的经验 范例，并建议开发一个广泛使用的版本的Loewenstein-Acevedo量表， 语义干扰和学习（LASSI-L）。如在申请的主体中所指出的，LASSI-L已经示出了 在国家和国际研究中， 在缺乏可检测的认知能力的情况下，鉴定具有淀粉样蛋白沉积证据的个体 用标准的神经心理学方法来评估这些损伤。LASSI的计算机化版本，LASSI- 简要计算机化（LASSI-BC）版本已在我们的NIH初步开发和验证 资助的研究，但需要重大改进，使其适用于商业用途。这个目标 第二阶段SBIR是开发下一代语义干扰测量（LASSI-D），使其 远程递送和评分是可行的，可用于大规模临床试验筛选和临床使用。鉴于 在美国和世界其他地区，有数百万人有患痴呆症的风险， 干预是至关重要的，评估战略的可用性将广泛增加获得 早期筛查和检测。拟议的第二阶段SBIR响应PAS-19-316，SBIR第二阶段。在 具体而言，该应用程序直接专注于开发：“敏感，具体和标准化的测试， 轻度认知功能障碍（MCI）和痴呆症的诊断筛查，包括开发新的，成本- 有效的，微创的生物标志物，可用于筛选在一般人群和 社区设置”。在这项研究中，我们将评估LASSI-D是否也对最早期敏感 MCI以及与血液淀粉样蛋白和tau生物标志物相关。该系统将被设计为 自我管理，因此，广泛用于大规模的临床试验筛选一般 社区环境中的人群和临床使用。我们公司正在进行第二阶段SBIR，重点是 用于治疗MCI功能缺陷的自我管理系统和基于云的平台， 功能技能评估和培训计划（FUNSAT）的交付将用于开发 LASSI-D。我们的长期目标是开发一套商业上成功的产品， 识别认知和功能下降的风险，预防和治疗认知和功能下降，并保持认知健康， 老年人的功能独立性。FUNSAT和LASSI-L的商业化工作已经开始 我们有几个大规模的潜在客户的承诺。