Alzheimer's Disease Neuroimaging Initiative

描述（由申请人提供）：本项目的目标是确定整个阿尔茨海默病（AD）谱的临床、认知、成像、遗传和生物化学生物标志物特征之间的关系，因为病理学从正常衰老发展到非常轻微的症状，再到轻度认知障碍（MCI），再到痴呆。ADN 1将告知AD的神经科学，识别诊断和预后标志物，识别可用于临床试验的结果测量，并帮助开发最有效的临床试验方案。ADNI 2继续目前资助的AD神经成像倡议（ADNI 1），这是学术界和工业界之间的公共/私人合作，以研究AD的生物标志物，以及最近资助的补充ADNI目标和活动（GO）的大机会赠款。ADN 1的新方面包括招募患有早期MCI（EMCI）的受试者，F18淀粉样蛋白成像，以及获得所有受试者的所有临床/认知、腰椎穿刺CSF和血浆生物标志物以及MRI/PET数据。该ADN 1更新的目标将通过以下方式实现：1）继续对先前在ADN 1中登记的476名正常对照和晚期MCI（LMCI）受试者进行年度临床/认知/MRI随访; 2）对在GO ADN 1资助中登记的200名EMCI受试者进行随访; 3）额外招募新的健康对照（n=150），EMCI（n=100，其添加到GO中招募的200名受试者中）、LMCI（n=150）和AD（n=150）受试者; 4）F18淀粉样蛋白PET（使用来自AVID，Inc.在基线扫描后2年，对所有入组ADNI 2的新受试者以及FDG PET进行第二次F18淀粉样蛋白PET检查，并对所有剩余的ADNI 1、GO和ADNI 2受试者进行第二次F18淀粉样蛋白PET检查; 5）继续对所有受试者进行年度临床/认知/抽血/腰椎穿刺CSF检查和MRI检查。所有收集的数据将由ADN 1研究者（包括生物统计核心）处理和分析，并提供给世界上所有要求密码的合格科学家，而没有禁运。将复制从当前ADN 1数据开发的假设，并测试新的假设，特别是关于EMCI和F18淀粉样蛋白成像。ADN 1在其他国家催生了大型多站点项目。世界上没有其他大型多中心研究能够以该应用程序的样本量和统计功效解决这些复杂问题。

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.