Alzheimer's Disease Neuroimaging Initiative

描述（由申请人提供）：本阿尔茨海默病神经影像学倡议（ADNI）的主要目标是：1）开发改进的方法，这将导致获得阿尔茨海默病（AD）、轻度认知障碍（MCI）和老年对照患者的纵向、多部位磁共振成像（MRI）和正电子发射断层扫描（PET）数据的统一标准。2)获得一个普遍可访问的数据库，它描述了大脑结构和新陈代谢的纵向变化。同时，获取临床、认知和生物标志物数据，以验证成像替代物。3)在涉及这些患者组的试验中，确定那些能提供最大把握度来确定治疗效果的方法。已经组建了一个在AD临床试验、MRI、PET、生物标志物和信息学方面具有丰富经验的研究人员团队。研究设计是对申请要求（RFA）的回应。该项目的前6个月将致力于在所有40-45个参与研究中心建立统一的MRI和PET采集技术，然后开始招募受试者。如果有用，将评估并实施MRI和PET量化的改进方法。所有受试者将每6个月接受一次临床/认知评估和1.5 T结构MRI，持续2-3年。大约50%的受试者还将在相同的时间间隔接受18氟脱氧葡萄糖（FDG）PET扫描，25%的受试者（未接受PET）将在3特斯拉下接受MRI。AD受试者（n=200）将在0、6、12、18和24个月时接受研究。将在0、6、12、18、24、30和36个月时研究转化为AD的高风险MCI受试者（n= 400）。将在0、6、12和24个月时研究年龄匹配的对照组（n=200）。所有MRI和PET扫描将由神经影像中心的MRI和PET部门快速评估质量，以便受试者在必要时重新扫描。所有临床数据将由加州圣地亚哥大学（UCSD）AD合作研究项目的临床中心收集、监测和储存。宾夕法尼亚大学（UPenn）将收集生物标志物样本。所有原始和处理后的图像数据将在加州大学洛杉矶分校（UCLA）的神经影像学实验室（LONI）存档。试点研究将评估不同的图像处理方法来测量感兴趣的大脑区域。所有数据将由项目统计员进行监测和分析，并根据要求进行数据库查询。所有临床、认知、成像和生物标志物数据库将被链接，所有原始、处理和统计分析的数据将通过互联网全面、快速地向公众开放。这项研究的结果将是非常有用的设计未来的AD和MCI试验。

DESCRIPTION (provided by applicant): The major goals of this Alzheimer's Disease Neuroimaging Initiative (ADNI) are to: 1) Develop improved methods, which will lead to uniform standards for acquiring longitudinal, multi-site Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) data on patients with Alzheimer's disease (AD), mild cognitive impairment (MCI), and elderly controls. 2) Acquire a generally accessible data repository, which describes longitudinal changes in brain structure and metabolism. In parallel, acquire clinical, cognitive and biomarker data for validation of imaging surrogates. 3) Determine those methods which provide maximum power to determine treatment effects in trials involving these patient groups. A team of investigators with considerable experience in AD clinical trials, MRI, PET, biomarkers and informatics has been assembled. Study design is in response to the Request For Applications (RFA). The first six months of the project will be devoted to establishing uniform MRI and PET acquisition techniques at all of the 40-45 participating sites, followed by initiation of subject recruitment. Improved methods for MRI and PET quantification will be assessed and implemented if useful. All subjects will have clinical/cognitive assessments and 1.5 T structural MRI every 6 months for 2-3 years. Approximately 50% of subjects will also have 18fluorodeoxyglucose (FDG) PET scans at the same time intervals and 25% of subjects (who do not also have PET) will have MRI at 3 Tesla. AD subjects (n=200) will be studied at 0, 6, 12, 18, and 24 months. MCI subjects at high risk for conversion to AD (n= 400) will be studied at 0, 6, 12, 18, 24, 30, and 36 months. Age matched controls (n=200) will be studied at 0, 6, 12, and 24 months. All MRI and PET scans will be rapidly assessed for quality by the MRI and PET components of the Neuroimaging Center so that subjects may be rescanned if necessary. All clinical data will be collected, monitored, and stored by the Clinical Center at the AD Cooperative Studies program at the University of California San Diego (UCSD). The University of Pennsylvania (UPenn) will collect biomarker samples. All raw and processed image data will be archived at The Laboratory of Neuroimaging (LONI) at the University of California Los Angeles (UCLA). Pilot studies will evaluate different image processing methods to measure brain regions of interest. All data will be monitored and analyzed by project statisticians, and data base queries will be performed on request. All clinical, cognitive, imaging, and biomarker databases will be linked and all raw, processed, and statistically analyzed data will be fully and rapidly accessible to the public through the Internet. The results of this study will be extremely useful for design of future AD and MCI trials.