Alzheimer's Disease Neuroimaging Initiative

描述(申请人提供)：这个项目的目标是确定整个阿尔茨海默病(AD)的临床、认知、成像、遗传和生化生物标记物特征之间的关系，因为病理从正常衰老到非常轻微的症状，再到轻微的认知障碍(MCI)，再到痴呆症。ADN1将为AD的神经科学提供信息，确定诊断和预后标记物，确定可用于临床试验的结果衡量标准，并帮助开发最有效的临床试验方案。ADNI2继续目前资助的AD神经成像计划(ADNI1)，这是学术界和工业界之间的公共/私人合作，以研究AD的生物标记物，以及最近资助的Grand Opportunities赠款，以补充ADN1的目标和活动(GO)。ADN1的新方面包括招募受试者进行早期MCI(EMCI)、F18淀粉样蛋白成像，并获得所有受试者的所有临床/认知、腰椎穿刺液和血浆生物标记物以及MRI/PET数据。此次ADN1更新的目标将通过以下方式实现：1)对之前在ADNI1中登记的476名正常对照和晚期MCI(LMCI)受试者继续进行年度临床/认知/MRI随访；2)在GO ADN1补助金中登记200名EMCI受试者之后；3)增加新的健康对照(n=150)、EMCI(在参加围棋的200名受试者基础上增加100名)、LMCI(n=150)和AD(n=150)受试者；4)F18淀粉样蛋白PET(使用Avid，Inc.的F18 AV-45)。对所有参加ADNI2的新受试者，以及FDG PET，并在基线扫描两年后对所有剩余的ADNI1、GO和ADNI2受试者进行第二次F18淀粉样蛋白PET检查；5)继续进行年度临床/认知/抽血/腰椎穿刺术，对所有受试者进行脑脊液和MRI检查。所有收集的数据将由包括生物统计核心在内的ADN1调查人员处理和分析，并向世界上所有要求密码的合格科学家提供，而不受禁运。根据当前ADN1数据开发的假说将被复制，并测试新的假说，特别是关于EMCI和F18淀粉样蛋白成像。ADNl在其他国家催生了大型多地点项目。世界上没有其他大型多站点研究以样本大小和这一应用程序的统计能力来解决这些复杂的问题。

DESCRIPTION (provided by applicant): The goal of this project is to determine relationships among the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of Alzheimer's disease (AD), as pathology evolves from normal aging to very mild symptoms, to mild cognitive impairment (MCI), to dementia. ADNl will inform the neuroscience of AD, identify diagnostic and prognostic markers, identify outcome measures that can be used in clinical trials, and help develop the most effective clinical trial scenarios. ADNI2 continues the currently funded AD Neuroimaging Initiative (ADNI1), a public/private collaboration between academia and industry to study biomarkers of AD as well as a recently funded Grand Opportunities grant that supplements ADNl goals and activities (GO). New aspects of ADNl include enrolling subjects with early MCI (EMCI), F18 amyloid imaging, and obtaining all clinical/cognitive, lumbar puncture CSF and plasma biomarker, and MRI/PET data on all subjects. The goals of this ADNl renewal will be accomplished by: 1) continuing annual clinical/cognitive/MRI follow up of the 476 normal controls and late MCI (LMCI) subjects previously enrolled in ADNI1; 2) following the 200 EMCI subjects enrolled in the GO ADNl grant; 3) additional enrollment of new healthy controls (n=150), EMCI (n=100 which adds to the 200 subjects enrolled in GO), LMCI (n=150), and AD (n=150) subjects; 4) performance of F18 amyloid PET (using F18 AV-45 from AVID, Inc.) on all new subjects enrolled in ADNI2, together with FDG PET, and to obtain a 2nd F18 amyloid PET on all remaining ADNI1, GO, and ADNI2 subjects 2 years after the baseline scan; 5) continue to obtain annual clinical/cognitive/blood draw/lumbar puncture for CSF, and MRI on all subjects. All collected data will be processed and analyzed by ADNl investigators including the Biostatistical Core, and made available to all qualified scientists in the world who request a password, without embargo. Hypotheses developed from current ADNl data will be replicated and new hypotheses tested, especially concerning EMCI and F18 amyloid imaging. ADNl spawned large multisite projects in other countries. No other large multisite study in the world addresses these complex issues with the sample size and statistical power of this application.