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: 8573005
• 金额: $ 103.98万
• 依托单位: SRI INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-06-07 至 2013-06-06
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8573005
• 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; Screening procedure; Services; Symptoms; Testing; Toxic effect; Toxicology; Translating; United States Food and Drug Administration; age related; drug discovery; drug mechanism; falls; pre-clinical; prevent; programs

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.

开发和测试治疗阿尔茨海默病(AD)相关认知障碍的新药的努力是国家老龄研究所(NIA)的一项主要方案活动，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。目前缺乏任何能够统一减缓或逆转疾病进展、改善症状或预防疾病的化合物，这要求尽一切努力促进新化合物的开发和测试。开发治疗其他与衰老有关的疾病，如骨质疏松症的化合物的必要性也很明显。此外，正电子发射断层扫描(PET)显像剂的问世，用于评估AD的大脑β-淀粉样蛋白和其他病理生理学特征，需要在人体研究之前对这些试剂进行毒理学测试。然而，在促进新化合物的开发和测试方面，我们的总体努力仍然存在差距。具体地说，正在开发新化合物的研究人员需要资源，以便在将化合物投入临床试验之前可以评估这些化合物的潜在有害毒理活性。这是一个非常昂贵的过程，几乎超出了所有调查人员的能力范围。调查人员已经联系了NIA项目的工作人员，他们认为这些化合物似乎有望用于治疗阿尔茨海默病，并希望进行临床试验，但他们没有资源进行强制性毒理学筛查。