Nanowire Sensor Array-based Assay for Early Diagnosis of Alzheimer's Disease

基于纳米线传感器阵列的阿尔茨海默病早期诊断检测

• 批准号: 8780342
• 负责人: Maksudul Alam
• 金额: $ 22.5万
• 依托单位: INNOSENSE, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8780342
• 关键词: Academia; Address; Alzheimer disease detection; Alzheimer' s Disease; American; Amyloid; Amyloid beta-Protein; Antibodies; Autopsy; Bedside Testings; Binding; Biological Assay; Biological Markers; Biological Sciences; Biosensor; Biotechnology; Blood; Brain; Brain Diseases; California; Caring; Cerebrospinal Fluid; Clinic; Clinical; Clinics and Hospitals; Cognitive; Collaborations; Communities; Confusion; Dementia; Development; Devices; Diagnosis; Diagnostic; Diagnostic tests; Disease; Disorientation; Early Diagnosis; Elderly; Engineering; Evaluation; FDA approved; Government; Hand; Health; Health Personnel; Healthcare Systems; Human Resources; Image; Immunoassay; Industry; Judgment; Knowledge; Letters; Los Angeles; Marketing; Measurement; Measures; Memory Loss; Microelectrodes; Modeling; Molecular; Molecular Conformation; Monitor; Monoclonal Antibodies; Neurodegenerative Disorders; Neurologist; Noise; Onset of illness; Pathogenesis; Patient Care; Patient Monitoring; Patients; Pattern; Performance; Personality; Persons; Pharmacologic Substance; Phase; Phosphate Buffer; Polymers; Positron-Emission Tomography; Production; Proteins; Protocols documentation; Provider; Qualifying; Radiopharmaceuticals; Reaction Time; Reproducibility; Research; Saline; Sampling; Senile Plaques; Sensitivity and Specificity; Services; Signal Transduction; Site; Solutions; Specialist; Staging; Structure; Surface; System; Technology; Testing; Therapeutic; Time; United States; Universities; Urine; Work; antibody conjugate; assay development; base; clinical Diagnosis; clinically significant; commercialization; cost; cost effective; density; design; experience; improved; in vivo; interest; nanowire; nervous system disorder; point of care; prevent; professor; prognostic; prototype; response; screening; sensor; socioeconomics; tau Proteins; tool

DESCRIPTION (provided by applicant): Over 5 million Americans are currently believed to have Alzheimer's disease (AD), the most common form of dementia. This number could reach 16 million by 2050. AD is a terminal, progressive brain disorder with no known cause or cure. AD leads to memory loss, confusion, impaired judgment, personality changes, disorientation, and the inability to communicate. The Alzheimer's Association estimates that 450,000 people will die with Alzheimer's, meaning they will die after developing the disease. The cost of care is estimated to be $203 billion in the United States in 2013. In addition, 15.4 million Americans provide unpaid care valued at $216 billion for persons with Alzheimer's and other forms of dementia. Currently, there is no definitive clinical diagnosis for AD other than a postmortem autopsy. Because early diagnosis could enable better planned and coordinated care, there is an urgent need to develop a cost-effective, highly sensitive and selective early stage diagnostic tool for AD. InnoSense LLC (ISL) aims to develop a highly sensitive nanowire-based microelectronic biosensor array (Adnos")-based assay system to provide rapid, reliable, and sensitive early diagnosis of AD by detecting a generally accepted panel of AD-associated protein biomarkers. In Phase I, we aim to demonstrate the performance of an Adnos test system by unambiguously detecting AD protein biomarkers in spinal fluid samples at the nanomolar to picomolar level. ISL will grow nanowires, conjugate antibodies, create a site-specific array, and study assay-related issues, including the following: (1) specific and nonspecific binding, (2) response time, (3) assay volume, (4) sensitivity, accuracy, and measurement precision and (5) signal-to-noise ratio. This Adnos system will have the following widespread socioeconomic benefits: (1) easy-to-use and cost- effective point-of-care tests in doctor's offices, clinics and hospitals, (2) improved and reliable patient care through a multifunctional prognostic/diagnostic test that can be administered by healthcare providers, (3) a valuable research tool for studies of non-AD dementia and neurological diseases and conditions, and (4) a new immunoassay-based research tool for the pharmaceutical/biotechnology industries, government, and academia.

描述(申请人提供)：目前有500多万美国人被认为患有阿尔茨海默病(AD)，这是最常见的痴呆症形式。到2050年，这一数字可能达到1600万。AD是一种晚期进行性大脑疾病，没有已知的病因或治疗方法。AD会导致记忆力丧失、神志不清、判断力受损、人格改变、迷失方向以及无法沟通。阿尔茨海默氏症协会估计，将有45万人死于阿尔茨海默氏症，这意味着他们将在患上阿尔茨海默氏症后死亡。据估计，2013年美国的医疗费用为2030亿美元。此外，1540万美国人为阿尔茨海默氏症和其他形式的痴呆症患者提供价值2160亿美元的无偿护理。目前，除了尸检外，尚无明确的AD临床诊断。由于早期诊断可以更好地规划和协调护理，因此迫切需要开发一种具有成本效益、高度敏感和选择性的AD早期诊断工具。InnoSense LLC(ISL)旨在开发一种基于纳米线的微电子生物传感器阵列(Adnos)的检测系统，通过检测一组公认的AD相关蛋白质生物标记物来提供快速、可靠和灵敏的早期诊断。在第一阶段，我们的目标是通过在纳摩尔到皮摩尔水平上明确地检测脊髓液中的AD蛋白生物标记物来展示Adnos测试系统的性能。ISL将生长纳米线、结合抗体、创建特定部位的阵列，并研究与检测相关的问题，包括以下内容：(1)特异性和非特异性结合、(2)反应时间、(3)检测 体积；(4)灵敏度、准确度和测量精度；(5)信噪比。这种Adnos系统将具有以下广泛的社会经济效益：(1)医生办公室、诊所和医院中易于使用且成本效益高的护理点测试；(2)通过可由医疗保健提供者管理的多功能预后/诊断测试改善和可靠的患者护理；(3)成为研究非AD痴呆症和神经疾病和状况的宝贵研究工具；以及(4)为制药/生物技术行业、政府和学术界提供一种基于免疫分析的新研究工具。