Alzheimer's Disease Neuroimaging Initiative

阿尔茨海默病神经影像计划

• 批准号: 9930184
• 负责人: MICHAEL W WEINER
• 金额: $ 681.8万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-30 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9930184
• 关键词: Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer’s disease biomarker; American; Amyloid; Amyloid beta-Protein; Autopsy; Biological Markers; Blood Tests; Brain; Brain Diseases; Brain imaging; Cerebrospinal Fluid; Clinical; Clinical Treatment; Clinical Trials; Clinical Trials Design; Clinical assessments; Cognition; Cognitive; Communities; Data; Dementia; Deposition; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Diffusion; Disease; Disease Progression; Drug Industry; Emotions; Enrollment; Exclusion Criteria; Foundations; Funding; Genes; Genetic; Goals; Gold; Government; Impaired cognition; Industry; Lead; Magnetic Resonance Imaging; Measurement; Measures; Methods; Nerve Degeneration; Neurofibrillary Tangles; Outcome Measure; PGRN gene; Paper; Pathogenesis; Pathology; Patients; Peptides; Perfusion; Phenotype; Positron-Emission Tomography; Proteins; Publications; Publishing; Research Design; Research Personnel; Resource Allocation; Rest; Review Committee; Sleep; Specificity; Standardization; Structure; Synapses; Tauopathies; Therapeutic Trials; Validation; Visit; alpha synuclein; biomarker discovery; clinical Diagnosis; cognitive testing; control trial; cost; data sharing; design; diagnostic accuracy; effective therapy; family support; follow-up; metabolomics; neuroimaging; novel diagnostics; pre-clinical; prevent; public-private partnership; tau Proteins; tool; treatment effect; treatment site; treatment trial

Overall: Project Summary/Abstract The overall goal of the Alzheimer's Disease (AD) Neuroimaging Initiative (ADNI) is to discover, standardize, and validate biomarkers for AD treatment trials. Validation is accomplished by comparing and correlating clinical/cognitive with biomarker data. Impact of ADNI has been to optimize, standardize and validate biomarkers, especially brain amyloid by PET and CSF measurements of Aβ peptides, termed “Aβ amyloid- phenotyping.” There are 907 papers published using ADNI data. We will follow-up with annual visits, 697 subjects previously enrolled in ADNI2 (cognitively normal controls, subjects currently enrolled subjects with MCI, and patients with dementia diagnosed as AD) and will enroll 371 new subjects, while collecting clinical, cognitive, MRI (structural, diffusion, perfusion, resting state), amyloid PET, FDG PET, cerebrospinal fluid (for a Aβ, tau, phosphotau, and other proteins), genetic and autopsy data. In addition longitudinal measurements of brain tau PET will be performed on all subjects. All data is available without embargo to from USC/LONI/ADNI. Specific Aims: 1. Longitudinal changes in cognition and associated biomarkers: To determine those measures of cognition and function, including composite measures, and those biomarker measures which best capture longitudinal change with highest statistical power to detect treatment effects in clinical trials. Longitudinal change of brain tau tangles measured with tau PET will be correlated/compared with other measures. 2. Prediction of cognitive decline: To determine the clinical, cognitive, and biomarker measures which best predict decline of cognition in cognitively normal controls, subjects with MCI, and patients with dementia. In addition, to determine those biomarkers, especially tau PET, which correlate with cognitive decline. 3. Validation: To validate biomarker measures obtained at baseline and longitudinally by correlating results with “gold standard” clinical measurements and pathology. 4. Clinical trial design: To determine the optimum outcome measures (especially rate of cognitive decline and tau PET), predictors of cognitive decline, and inclusion/exclusion criteria for clinical trials of cognitively normal subjects (for secondary preclinical AD trials) and MCI patients (for prodromal AD trials). 5. Discovery: To determine the effects of other known disease proteins found in AD brains (e.g. alpha- synuclein, TDP 43,progranulin) and genes, and newly discovered proteins (from proteinomics), genes,and other analytes (from metabolomics) which provide useful information concerning the pathogenesis/diagnosis of AD. Discovery is conducted through the add-on studies led/driven by ADNI investigators with oversight by the NIA and the ADNI Resource Allocation Review Committee (RARC). ADNI methods and data are used in study design by government and industry funded clinical trials. Continuation of ADNI will help lead to development of effective treatments which slow progression and prevent AD.

总体：项目摘要/摘要阿尔茨海默氏病（AD）神经影像学计划的总体目标 （ADNI）将发现，标准化和验证用于AD治疗试验的生物标志物。验证已完成 通过将临床/认知与生物标志物数据进行比较和相关。 ADNI的影响是优化， 标准化和验证生物标志物，尤其是通过Aβ肽的PET和CSF测量的脑淀粉样蛋白， 称为“Aβ淀粉样蛋白表型”。使用ADNI数据发表了907篇论文。我们将跟进 年度访问，697名先前参加ADNI2的受试者（认知正常对照，当前受试者 招募了MCI的受试者，并且患有痴呆症诊断为AD的患者，将招募371名新受试者， 同时收集临床，认知，MRI（结构，扩散，灌注，静止状态），淀粉样蛋白PET，FDG PET， 脑脊液（用于Aβ，TAU，磷酸和其他蛋白质），遗传和尸检数据。此外 将对所有受试者进行大脑tau PET的纵向测量。所有数据都没有 从USC/LONI/ADNI进行禁运。具体目的： 1。认知和相关生物标志物的纵向变化：确定那些措施 认知和功能，包括复合测量以及那些最能捕获的生物标志物测量值 在临床试验中，具有最高统计能力的纵向变化具有最高的统计能力。纵向 与其他测量值相比，用Tau PET测量的大脑Tau缠结的变化将与之相关/相比。 2。认知能力下降的预测：确定最佳的临床，认知和生物标志物措施 预测认知正常对照，MCI受试者和痴呆患者的认知下降。 另外，还可以确定那些与认知能力下降相关的生物标志物，尤其是Tau Pet。 3。验证：通过将结果相关联在基线和纵向上获得的生物标志物测量 具有“金标准”临床测量和病理。 4。临床试验设计：确定最佳结果指标（尤其是认知能力下降的速度和 Tau Pet），认知下降的预测指标，以及认知正常的临床试验的包容/排除标准 受试者（用于继发临床前AD试验）和MCI患者（用于前驱AD试验）。 5。发现：确定在AD大脑中发现的其他已知疾病蛋白的作用（例如α- 综合蛋白，TDP 43，progranulin）和基因，以及新发现的蛋白质（来自蛋白质组学），基因和 其他分析物（来自代谢组学）提供了有关发病/诊断的有用信息 广告。发现是通过由ADNI调查人员领导/驱动的，由ADNI调查人员进行的。 NIA和ADNI资源分配审查委员会（RARC）。 ADNI方法和数据用于研究 政府和行业基本临床试验的设计。 ADNI的延续将有助于发展 有效的治疗方法会减慢进展并预防AD。