Alzheimer's Disease Neuroimaging Initiative

描述(由申请人提供)：这项阿尔茨海默病神经成像计划(ADNI)的主要目标是：1)开发改进的方法，从而为获取阿尔茨海默病(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)数据建立统一标准。2)获取普遍可访问的数据存储库，描述大脑结构和新陈代谢的纵向变化。同时，获取临床、认知和生物标记物数据，以验证成像替代物。3)确定在涉及这些患者组的试验中提供最大功率以确定治疗效果的方法。已经组建了一支在AD临床试验、核磁共振、正电子发射计算机断层扫描、生物标志物和信息学方面具有相当经验的研究团队。研究设计是为了响应申请(RFA)。该项目的前六个月将致力于在所有40-45个参与地点建立统一的核磁共振成像和正电子发射计算机断层扫描采集技术，然后开始招募受试者。如果有用，将对改进的MRI和PET定量方法进行评估和实施。所有受试者将接受临床/认知评估和1.5T结构磁共振成像，每6个月进行一次，为期2-3年。大约50%的受试者还将在相同的时间间隔进行18F脱氧葡萄糖(FDG)PET扫描，25%的受试者(没有PET)将在3特斯拉进行MRI扫描。AD受试者(n=200)将在0、6、12、18和24个月进行研究。将在0、6、12、18、24、30和36个月对MCI受试者进行研究，这些受试者是转换为AD的高危人群(n=400)。年龄匹配的对照组(n=200)将在0、6、12和24个月时进行研究。所有MRI和PET扫描都将由神经成像中心的MRI和PET组件进行快速质量评估，以便在必要时重新扫描受试者。所有临床数据将由加州大学圣地亚哥分校(UCSD)AD合作研究计划的临床中心收集、监测和存储。宾夕法尼亚大学将收集生物标记物样本。所有原始和处理后的图像数据将在加州大学洛杉矶分校的神经成像实验室(LONI)存档。试点研究将评估不同的图像处理方法，以测量大脑感兴趣的区域。项目统计员将监测和分析所有数据，并应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连接起来，所有原始、处理和统计分析的数据将通过互联网全面和快速地向公众开放。这项研究的结果将对未来AD和MCI试验的设计非常有用。

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.