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Phase 1 Clinical Trial of CMS121, a Novel Therapeutic Candidate for Alzheimer's Disease

阿尔茨海默病新候选治疗药物 CMS121 的 1 期临床试验

基本信息

批准号：
10542565
负责人：
Pamela Anne Maher
金额：
$ 21.01万
依托单位：
VIROGENICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-15 至 2023-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10542565
关键词：
Adult Alzheimer&apos s Disease Alzheimer&apos s disease model Appearance Applications Grants Brain COVID-19 COVID-19 testing Clinic Clinical Clinical Research Clinical Trials Demographic Factors Disease Dose Double-Blind Method Drug Kinetics Elderly Electrocardiogram Encapsulated Enrollment Fasting Female Food Funding Goals Grant Human Infection Methylcellulose Oral Oral Administration Participant Pharmaceutical Preparations Phase I Clinical Trials Placebo Control Population Procedures Process Randomized Request for Applications Running SARS-CoV-2 infection Safety Specific qualifier value Testing Therapeutic Time Vaccines Variant Virus age related base capsule clinical research site cohort cost dosage drug candidate healthy volunteer male mouse model novel novel therapeutics parent grant phase 1 study phase 1 testing prevent small molecule therapeutic candidate volunteer

项目摘要

Abstract The parent grant for this application supports a Phase I clinical trial of CMS121, a small molecule that has shown efficacy in multiple mouse models of Alzheimer's Disease and which affords a different therapeutic approach for treatment of AD in humans. In this application we request supplemental funds to cover the costs of COVID-19 mitigation procedures and COVID-19 testing of trial subjects. These processes and associated costs were not necessary at the time of application due in large part to the rollout of highly effective vaccines and declining infections but have become essential now due to repeated surges in infections and the appearance of highly infectious variants of the virus. The mitigation and testing procedures are necessary to protect the clinical and non-clinical staff, as well as trial subjects at the clinical site from COVID-19 infection.

摘要该申请的母公司资助支持CMS 121的I期临床试验，CMS 121是一种小分子，在多种阿尔茨海默病小鼠模型中显示出有效性，用于治疗人类AD的治疗方法。在本申请中，我们要求补充资金，支付COVID-19缓解程序和试验受试者COVID-19检测的费用。这些申请时不需要程序和相关费用，主要原因是推出高效疫苗和减少感染，但由于反复出现的感染的激增和高传染性病毒变种的出现。的减轻和测试程序是必要的，以保护临床和非临床工作人员，以及试验受试者在感染COVID-19的临床部位。