ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE

阿尔茨海默病神经影像计划

• 批准号: 7378356
• 负责人: HENRY RUSINEK
• 金额: $ 0.09万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378356
• 关键词: ALZHEIMER; DISEASE; NEUROIMAGING; INITIATIVE

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This Alzheimer's Disease Neuroimaging Initiative (ADNI) is a proposal to evaluate the use of biomarkers and neuroimaging to assess changes associated with the progression of Alzheimer's Disease (AD). A total of 200 normal, 400 mild cognitive impaired (MCI) and 200 early AD subjects will be studied, 16 per site. The study will examine the hypothesis that PET and/or CT will be a more sensitive and reliable marker of AD progression than cognitive and neuropsychological measures. The study will use repeated measures over 2-3 years. The major goals of the ADNI are as follows: (a) Develop uniform standards for acquiring longitudinal, multi-site MRI and PET data on patients with Alzheimer's disease (AD), mild cognitive impairment (MCI), and elderly controls. (b) 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. (c) Develop methods which will provide maximum power to determine treatment effects in trials involving these patients. (d) Test a series of hypotheses, including 1) hippocampal volume and cingulate metabolic rate predict conversion from MCI to AD; 2) rates of conversion from MCI to AD average 10-15%/year; 3) baseline scores on logical memory and APOE4 status predict conversion from MCI to AD; 4) CSF and plasma isoprostane levels are associated with disease severity. Study Design: This is a non-randomized natural history non-treatment study in which a total of 800 subjects, including 200 normal controls, 400 individuals with MCI, and 200 subjects with mild AD will be recruited at approximately 50 sites in the United States and Canada for longitudinal follow up. Procedures: All subjects will have serial clinical/cognitive assessments and 1.5 T structural MRI for 2-3 years. Approximately 50% of subjects will also have FDG PET scans at the same time intervals. 25% of subjects (who have not been scanned using PET) will have MRI at 3 Tesla. AD subjects (n=200) will be studied at 0, 6, 12, and 24 months. MCI subjects at high risk for conversion to AD (n= 400) will be studied at 0, 6, 12, 18, 24 and 36 months. Age-matched controls (n=200) will be studied at 0, 6, 12, 24 and 36 months. All MRI and PET scans will be rapidly assessed for quality so that subjects may be rescanned if necessary. All clinical data will be collected, monitored, and stored by the Coordinating Center at UCSD. U Penn will collect biomarker samples. All raw and processed image data will be archived at LONI. Outcome Measures: (a) Rate of conversion from MCI to AD. (b) Rate of volume change of whole brain and hippocampus. (c) Rates of change on each specified biomarker. (d) Rates of change of glucose metabolism for specified regions of interest on PET scanning. (e) Group differences for each imaging and biomarker measurement.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子弹和调查员（PI）可能已经从其他NIH来源获得了主要资金，因此可以在其他清晰的条目中代表。列出的机构适用于该中心，这不一定是调查员的机构。这项阿尔茨海默氏病神经影像学倡议（ADNI）是评估生物标志物和神经影像学以评估与阿尔茨海默氏病（AD）相关的变化的建议。总共将研究200名正常，400个轻度认知障碍（MCI）和200名早期AD受试者，每个站点16个。该研究将研究以下假设：与认知和神经心理学指标相比，PET和/或CT将是AD进展的更敏感和可靠的标志。该研究将在2 - 3年内使用重复的措施。 ADNI的主要目标如下：（a）制定了有关阿尔茨海默氏病（AD），轻度认知障碍（MCI）和老年人控制患者的纵向，多站点MRI和PET数据的统一标准。 （b）获取一个普遍可访问的数据存储库，该存储库描述了大脑结构和代谢的纵向变化。同时，获取临床认知和生物标志物数据以验证成像替代物。 （c）开发方法，这些方法将提供最大的能力来确定涉及这些患者的试验的治疗效果。 （d）测试一系列假设，包括1）海马体积和扣带代谢率预测从MCI转化为AD； 2）从MCI到广告平均10-15％/年的转换率； 3）关于逻辑内存和APOE4状态的基线得分预测从MCI转换为AD； 4）CSF和血浆异丙烷水平与疾病的严重程度有关。 研究设计：这是一项非随机自然历史的非治疗研究，其中总共有800名受试者，包括200名正常对照，400名具有MCI的人，200名受试者将在美国和加拿大的大约50个地点招募，以进行纵向随访。 程序：所有受试者将进行连续的临床/认知评估和1.5 T结构MRI 2 - 3年。大约50％的受试者还将在同一时间间隔进行FDG PET扫描。 25％的受试者（尚未使用PET扫描的受试者）将在3特斯拉的MRI中进行MRI。 AD受试者（n = 200）将在0、6、12和24个月进行研究。将在0、6、12、18、24和36个月中研究具有高度转换为AD的MCI受试者（n = 400）。年龄匹配的对照（n = 200）将在0、6、12、24和36个月进行研究。所有MRI和PET扫描将迅速评估质量，以便在必要时可以撤离受试者。将由UCSD的协调中心收集，监测和存储所有临床数据。 U Penn将收集生物标志物样品。所有原始图像数据都将在LONI归档。 结果指标：（a）从MCI到AD的转换率。 （b）整个大脑和海马的体积变化率。 （c）每个指定生物标志物的变化率。 （d）针对PET扫描的特定区域的葡萄糖代谢变化率。 （e）每个成像和生物标志物测量的组差异。