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（由申请人提供）：目前，超过 500 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。到 2050 年，这一数字可能会达到 1600 万。 AD 是一种晚期、进行性脑部疾病，病因不明，也无法治愈。 AD 会导致记忆丧失、混乱、判断力受损、性格改变、迷失方向和无法沟通。阿尔茨海默氏症协会估计，45 万人将死于阿尔茨海默氏症，这意味着他们将在患上这种疾病后死亡。 2013 年美国的护理费用估计为 2030 亿美元。此外，1540 万美国人为阿尔茨海默病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，除了死后尸检外，尚无 AD 明确的临床诊断。由于早期诊断可以更好地计划和协调护理，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高灵敏度微电子生物传感器阵列 (Adnos") 检测系统，通过检测公认的 AD 相关蛋白质生物标志物组来提供快速、可靠且灵敏的 AD 早期诊断。在第一阶段，我们的目标是通过以纳摩尔至皮摩尔水平明确检测脊髓液样本中的 AD 蛋白生物标志物来证明 Adnos 测试系统的性能，ISL 将生长纳米线、缀合抗体、创建位点特异性阵列，以及研究与测定相关的问题，包括以下内容：(1) 特异性和非特异性结合，(2) 响应时间，(3) 测定 体积，(4) 灵敏度、准确度和测量精度，以及 (5) 信噪比。该 Adnos 系统将具有以下广泛的社会经济效益：(1) 在医生办公室、诊所和医院进行易于使用且具有成本效益的现场护理测试，(2) 通过多功能预后/改善和可靠的患者护理可由医疗保健提供者进行的诊断测试，(3) 用于研究非 AD 痴呆和神经系统疾病和病症的有价值的研究工具，以及 (4) 用于制药/生物技术行业的基于免疫测定的新研究工具，政府、学术界。