ADNI Duke Supplement

ADNI 杜克增刊

基本信息

批准号：
8807562
负责人：
Rima F Kaddurah-Daouk
金额：
$ 17.03万
依托单位：
NORTHERN CALIFORNIA INSTITUTE/RES/EDU
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-08-15 至 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8807562
关键词：
Academia Address Alzheimer disease prevention Alzheimer&apos 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

Academia Address Alzheimer disease prevention Alzheimer&apos 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

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项目摘要

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）：该项目的目的是确定阿尔茨海默氏病（AD）的临床，认知，成像，遗传和生化生物标志物特征（AD）的关系，因为病理学从正常衰老到非常轻度的症状，变为轻度的认知障碍（MCI）。 ADNL将告知AD的神经科学，识别诊断和预后标记，确定可用于临床试验中的结果指标，并有助于开发最有效的临床试验场景。 ADNI2继续进行了当前资助的AD神经影像计划（ADNI1），这是学术界与行业之间的公共/私人合作，旨在研究AD的生物标志物，以及最近资助的大机会赠款，以补充ADNL目标和活动（GO）。 ADNL的新方面包括招募早期MCI（EMCI），F18淀粉样蛋白成像，并获得所有临床/认知，腰椎穿刺CSF和血浆生物标志物以及所有受试者的MRI/PET数据。该ADNL更新的目标将通过：1）继续对476个正常对照组和先前已入学的476例MCI（LMCI）受试者进行年度临床/认知/MRI随访； 2）遵循200名EMCI受试者参加了GO ADNL赠款； 3）额外的新健康对照组（n = 150），EMCI（n = 100，增加了GO中的200名受试者），LMCI（n = 150）和AD（n = 150）受试者； 4）在ADNI2中招募的所有新受试者以及FDG PET一起使用F18淀粉样蛋白PET（使用F18 AV-45）的性能，并在所有剩余的ADNI1，GO和ADNI2受试者中获得2年后2年后2年后获得2年的F18淀粉样蛋白PET； 5）继续为CSF获得年度临床/认知/吸血/腰椎穿刺，以及所有受试者的MRI。所有收集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，并提供给无需禁运密码的世界上所有合格的科学家。将从当前的ADNL数据产生的假设将被复制，并测试了新的假设，尤其是有关EMCI和F18淀粉样蛋白成像的假设。 ADNL在其他国家产生了大型多站点项目。世界上没有其他大型多站点研究可以通过本应用程序的样本量和统计能力来解决这些复杂的问题。