ALZHEIMER'S DISEASE NEUROIMAGING INITIATIVE

阿尔茨海默病神经影像计划

• 批准号: 7605760
• 负责人: HENRY RUSINEK
• 金额: $ 0.55万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605760
• 关键词: Age; Alzheimer' s Disease; Archives; Biological Markers; Brain; Canada; Clinical; Clinical Data; Cognitive; Computer Retrieval of Information on Scientific Projects Database; Data; Databases; Disease Progression; Elderly; Funding; Goals; Grant; Hippocampus (Brain); Image; Individual; Institution; Isoprostanes; Magnetic Resonance Imaging; Measurement; Measures; Memory; Metabolic; Metabolism; Methods; Monitor; Natural History; Outcome Measure; Patients; Plasma; Positron-Emission Tomography; Procedures; Randomized; Rate; Recruitment Activity; Research; Research Design; Research Personnel; Resources; Risk; Sampling; Scanning; Score; Series; Severity of illness; Site; Source; Specific qualifier value; Standards of Weights and Measures; Structure; Testing; United States; United States National Institutes of Health; Validation; apolipoprotein E-4; fluorodeoxyglucose positron emission tomography; follow-up; glucose metabolism; image processing; interest; mild neurocognitive impairment; neuroimaging; neuropsychological; time interval; treatment effect

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 该阿尔茨海默病神经影像倡议 (ADNI) 是一项评估生物标志物和神经影像学使用的提案，以评估与阿尔茨海默病 (AD) 进展相关的变化。 总共将研究 200 名正常受试者、400 名轻度认知障碍 (MCI) 受试者和 200 名早期 AD 受试者，每个中心 16 名受试者。 该研究将检验以下假设：PET 和/或 CT 将是比认知和神经心理学测量更敏感、更可靠的 AD 进展标志物。 该研究将在 2-3 年内使用重复测量。 ADNI 的主要目标如下： (a) 制定统一标准，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 MRI 和 PET 数据。 (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。 (c) 开发能够提供最大功效的方法来确定涉及这些患者的试验中的治疗效果。 (d) 测试一系列假设，包括 1) 海马体积和扣带回代谢率预测 MCI 向 AD 的转化； 2) 从 MCI 到 AD 的转换率平均为 10-15%/年； 3) 逻辑记忆和 APOE4 状态的基线分数预测从 MCI 到 AD 的转换； 4) 脑脊液和血浆异前列烷水平与疾病严重程度相关。 研究设计：这是一项非随机自然史非治疗研究，将在美国和加拿大约 50 个地点招募总共 800 名受试者，包括 200 名正常对照、400 名 MCI 个体和 200 名轻度 AD 受试者，进行纵向随访。 程序：所有受试者将接受为期 2-3 年的系列临床/认知评估和 1.5 T 结构 MRI。 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（未使用 PET 进行扫描）将在 3 特斯拉下进行 MRI 检查。 AD 受试者 (n=200) 将在 0、6、12 和 24 个月时进行研究。转化为 AD 高风险的 MCI 受试者 (n= 400) 将在 0、6、12、18、24 和 36 个月时进行研究。 年龄匹配的对照 (n=200) 将在 0、6、12、24 和 36 个月时进行研究。 所有 MRI 和 PET 扫描都将得到快速质量评估，以便在必要时对受试者进行重新扫描。 所有临床数据将由加州大学圣地亚哥分校协调中心收集、监测和存储。宾夕法尼亚大学将收集生物标志物样本。所有原始和处理后的图像数据都将存档在 LONI。 结果测量： (a) 从 MCI 到 AD 的转化率。 (b)全脑和海马体积变化率。 (c) 每个指定生物标志物的变化率。 (d) PET 扫描中特定感兴趣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间差异。