Alzheimer's Disease Neuroimaging Initiative

描述（由申请人提供）：该项目的目标是确定阿尔茨海默病（AD）全谱的临床、认知、影像学、遗传和生化生物标志物特征之间的关系，随着病理从正常衰老到非常轻微的症状，再到轻度认知障碍（MCI），再到痴呆。ADNl将为阿尔茨海默病的神经科学提供信息，确定诊断和预后标记，确定可用于临床试验的结果测量，并帮助制定最有效的临床试验方案。ADNI2延续了目前资助的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，旨在研究AD的生物标志物，以及最近资助的补充ADNl目标和活动（GO）的Grand Opportunities赠款。ADNl的新方面包括纳入早期MCI （EMCI）的受试者，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CSF和血浆生物标志物以及MRI/PET数据。ADNl更新的目标将通过以下方式实现：1)继续每年对476名正常对照和先前参加ADNI1的晚期MCI （LMCI）受试者进行临床/认知/MRI随访；2)跟踪参与GO ADNl资助的200名EMCI受试者；3)新入组健康对照（n=150）、EMCI （n=100，在GO入组200名受试者的基础上增加）、LMCI （n=150）和AD （n=150）受试者；4) F18淀粉样蛋白PET（使用AVID公司的F18 AV-45）和FDG PET对所有新入组ADNI2的受试者进行检测，并在基线扫描2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检测；5)继续每年对所有受试者进行临床/认知/抽血/腰椎穿刺CSF和MRI检查。所有收集到的数据将由ADNl的调查人员处理和分析，包括生物统计核心，并提供给世界上所有要求密码的合格科学家，没有禁运。从当前ADNl数据中发展出来的假设将被复制，新的假设将被测试，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站点项目。世界上没有其他大型的多地点研究用这个应用程序的样本量和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.