ALZHEIMER'S DISEASE NEUROIMAGING PROTOCOL (ADNI)

阿尔茨海默病神经影像方案 (ADNI)

• 批准号: 8166904
• 负责人: STEVEN Michael CRAMER
• 金额: $ 0.31万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8166904
• 关键词: Age; Alzheimer' s Disease; Clinical; Clinical Trials; Clinical Trials Design; Computer Retrieval of Information on Scientific Projects Database; Disease; Funding; Grant; Institution; Length; Modification; Patients; Population; Primary Prevention; Protocols documentation; Research; Research Personnel; Resources; Secondary Prevention; Source; Time; United States National Institutes of Health; cohort; drug development; drug market; high risk; interest; mild neurocognitive impairment; neuroimaging

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. At present, the development of drugs for patients with AD is costly and requires a considerable length of time. Currently marketed drugs have been developed for symptomatic treatment of AD and trials can be completed in 6 months. Trials designed to slow the rate of decline necessary to demonstrate disease modification require at least one year of treatment or longer to see adequate clinical separation of groups. The development of drugs for subjects with mild cognitive impairment (MCI) takes longer since these subjects progress more slowly. Current MCI trials require 3-4 years to establish either a sufficient rate of clinical decline or a sufficient number of conversions from MCI to AD to complete a clinical trial (R.C. Petersen, 2003). Subjects with MCI are of particular interest since they represent a population at particularly high risk of converting to AD and a population in which secondary prevention trials can be carried out. In the case of normal subjects, conversion to AD is very slow, averaging only 1-2 % / year depending on the age of the cohort. Thus, primary prevention trials for AD require 3,000-6,000 subjects followed for 5 to 7 years to achieve sufficient clinical endpoints.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 目前，针对AD患者的药物开发成本高昂，需要相当长的时间。目前已开发出对阿尔茨海默病症状治疗的上市药物，试验可在6个月内完成。为减缓疾病改变所需的下降速度而设计的试验需要至少一年或更长时间的治疗，才能看到充分的临床分组。为轻度认知障碍(MCI)受试者开发药物需要更长的时间，因为这些受试者进展较慢。目前的MCI试验需要3-4年的时间来确定足够的临床下降率或足够数量的从MCI到AD的转换以完成临床试验(R.C.Petersen，2003)。患有MCI的受试者特别感兴趣，因为他们代表了转化为AD风险特别高的人群，以及可以进行二级预防试验的人群。在正常受试者中，转化为AD的过程非常缓慢，根据年龄的不同，平均每年只有1-2%。因此，AD的一级预防试验需要3,000-6,000名受试者进行5到7年的跟踪调查，以达到足够的临床终点。