ALZHEIMER'S DISEASE NEUROIMAGING PROTOCOL (ADNI)

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 目前，针对AD患者的药物开发成本高昂，需要相当长的时间。目前已上市的药物已开发用于AD的对症治疗，试验可在6个月内完成。旨在减缓疾病改善所需的下降速度的试验需要至少一年或更长的治疗时间才能实现充分的临床分组。用于轻度认知障碍（MCI）受试者的药物开发需要更长时间，因为这些受试者进展更慢。目前的MCI试验需要3-4年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）。MCI受试者特别受关注，因为他们代表了转化为AD的风险特别高的人群和可以进行二级预防试验的人群。在正常受试者的情况下，向AD的转化非常缓慢，根据队列的年龄，平均仅为1- 2%/年。因此，AD的一级预防试验需要3，000 - 6，000例受试者随访5 - 7年，以达到足够的临床终点。

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.