Investigational New Drug Toxicology for Drugs to Treat Alzheimer's Disease and Ot

治疗阿尔茨海默病和其他疾病的药物的研究性新药毒理学

• 批准号: 8655038
• 负责人: KATHRYN BAUGHMAN
• 金额: $ 125.12万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-03-01 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8655038
• 关键词: Aging; Alzheimer disease prevention; Alzheimer' s Disease; Amyloid beta-Protein; Analytical Chemistry; Animal Testing; Basic Science; Biological Availability; Brain; Businesses; Categories; Clinical Research; Clinical Trials; Complement; Contracts; Data; Development; Disease; Disease Progression; Drug Kinetics; Evaluation; Grant; Human; Image; Impaired cognition; Individual; Investigational Drugs; National Institute on Aging; Osteoporosis; Pharmaceutical Preparations; Pharmacology; Pharmacotherapy; Positron-Emission Tomography; Preclinical Drug Development; Process; Research; Research Personnel; Resources; Safety; Services; Symptoms; Testing; Toxic effect; Toxicology; Translating; United States Food and Drug Administration; age related; drug discovery; drug mechanism; falls; pre-clinical; prevent; programs; screening

Efforts in developing and testing new drugs for the treatment of the cognitive impairment associated with Alzheimer's disease (AD) represent a major programmatic activity of the National Institute on Aging (NIA) but are now hindered by the lack of access of many investigators to animal testing facilities. The present paucity of any compounds which can uniformly slow or reverse the progression of the disease, ameliorate the symptoms, or prevent the disease requires that every effort be made to facilitate the development and testing of new compounds. The need to develop compounds for other aging related diseases such as osteoporosis is also apparent. Additionally, the advent of Positron Emission Tomography (PET) imaging agents for assessing brain beta-amyloid and other pathophysiological features of AD requires toxicological testing of these agents prior to human studies. However, there are still gaps in our overall effort to facilitate the development and testing of new compounds. Specifically, resources are needed by investigators who are developing new compounds so that the potential adverse toxicological activity of the compounds can be evaluated before they can be taken into clinical trials. This is a very expensive process and is beyond the resources of almost all investigators. NIA program staff have been contacted by investigators who have compounds that they believe seem promising for the treatment of Alzheimer's disease and that they would like to take into clinical trials, but they do not have the resources to have the mandatory toxicological screening done.

开发和测试用于治疗与阿尔茨海默病（AD）相关的认知障碍的新药的努力代表了国家老龄化研究所（NIA）的主要方案活动，但现在由于许多研究人员无法进入动物试验设施而受到阻碍。目前缺乏能够均匀地减缓或逆转疾病进展、改善症状或预防疾病的任何化合物，这要求尽一切努力促进新化合物的开发和测试。开发用于其他衰老相关疾病如骨质疏松症的化合物的需求也是显而易见的。此外，用于评估脑β-淀粉样蛋白和AD的其他病理生理学特征的正电子发射断层扫描（PET）成像剂的出现需要在人体研究之前对这些药剂进行毒理学测试。然而，在我们促进新化合物开发和测试的总体努力中仍然存在差距。具体而言，开发新化合物的研究人员需要资源，以便在将化合物纳入临床试验之前评估其潜在的不良毒理学活性。这是一个非常昂贵的过程，超出了几乎所有调查人员的资源。NIA项目的工作人员已经与研究人员取得了联系，他们认为这些化合物似乎有希望用于治疗阿尔茨海默病，并且他们希望将其纳入临床试验，但他们没有资源进行强制性毒理学筛查。