Alzheimer's Disease Neuroimaging Initiative

阿尔茨海默病神经影像计划

• 批准号: 8803060
• 负责人: MICHAEL W WEINER
• 金额: $ 10万
• 依托单位: NORTHERN CALIFORNIA INSTITUTE/RES/EDU
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8803060
• 关键词: Academia; Address; Alzheimer disease prevention; Alzheimer' s Disease; American; Amyloid; Amyloid deposition; Area; Autopsy; Biochemical; Biological Markers; Blood; Brain; Brain region; Characteristics; Chemicals; Clinical; Clinical Treatment; Clinical Trials; Clinical Trials Design; Clinical trial protocol document; Cognition; Cognitive; Collaborations; Complex; Country; Data; Dementia; Development; Diagnosis; Diagnostic; Diagnostic Procedure; Disease Progression; Early Diagnosis; Enrollment; Event; Funding; Future; Genetic; Genetic Markers; Goals; Grant; Hippocampus (Brain); Image; Impaired cognition; Industry; Knowledge; Magnetic Resonance Imaging; Measures; Methods; Monitor; Neurosciences; Outcome; Outcome Measure; Pathology; Performance; Plasma; Positron-Emission Tomography; Prevention; Principal Investigator; Process; Prognostic Marker; Qualifying; Research Personnel; Sample Size; Scanning; Scientist; Selection Criteria; Spinal Puncture; Staging; Subjects Selections; Symptoms; Temporal Lobe; Testing; amyloid imaging; cognitive change; cost; design; effective therapy; fluorodeoxyglucose positron emission tomography; follow-up; genome wide association study; improved; innovation; mild cognitive impairment; neuroimaging; neuropathology; normal aging; novel diagnostics; programs; public health relevance; tau Proteins; treatment effect; treatment trial; web site

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.

描述（由申请人提供）：该项目的目标是确定整个阿尔茨海默氏病 (AD) 的临床、认知、成像、遗传和生化生物标志物特征之间的关系，因为病理学从正常衰老演变为非常轻微的症状、 轻度认知障碍 (MCI)、 痴呆。 ADN1将为AD的神经科学提供信息，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。 ADNI2 继续当前资助的 AD 神经影像计划 (ADNI1)，这是学术界和工业界之间研究 AD 生物标志物的公共/私人合作，以及最近资助的大机会赠款，补充 ADN1 目标和活动 (GO)。 ADN1的新方面包括招募具有早期MCI(EMCI)、F18淀粉样蛋白成像的受试者，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。本次 ADN1 更新的目标将通过以下方式实现：1) 对先前纳入 ADNI1 的 476 名正常对照和晚期 MCI (LMCI) 受试者持续进行年度临床/认知/MRI 随访； 2) 在 GO ADN1 资助中注册的 200 名 EMCI 受试者之后； 3) 额外招募新的健康对照 (n=150)、EMCI (n=100，加入 GO 的 200 名受试者)、LMCI (n=150) 和 AD (n=150) 受试者； 4) 对参加 ADNI2 的所有新受试者进行 F18 淀粉样蛋白 PET（使用来自 AVID, Inc. 的 F18 AV-45）以及 FDG PET 的表现，并在所有剩余的 ADNI1、GO 和 ADNI2 受试者上获得第二次 F18 淀粉样蛋白 PET基线扫描后 2 年； 5) 继续获得所有受试者的年度临床/认知/抽血/腰椎穿刺脑脊液和 MRI。所有收集到的数据将由包括生物统计核心在内的 ADNl 调查人员进行处理和分析，并无限制地提供给世界上所有要求密码的合格科学家。根据当前 ADN1 数据提出的假设将被复制并测试新的假设，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多站点研究能够通过该应用程序的样本量和统计能力来解决这些复杂的问题。