权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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：
10553057
负责人：
Pamela Anne Maher
金额：
$ 25.17万
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/10553057
关键词：
Address Alzheimer&apos s Disease Alzheimer&apos s disease model Applications Grants Brain Budgets Clinical Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Conduct Clinical Trials Data Disease Dose Double-Blind Method Drug Kinetics Elderly Encapsulated Food Funding Goals Grant Human Measurement Measures Methylcellulose Modification Oral Oral Administration Parents Pharmaceutical Preparations Phase Phase I Clinical Trials Placebo Control Plasma Principal Investigator Protocols documentation Randomized Request for Applications Running Safety Signal Transduction Specific qualifier value Time Urine Work age related base capsule clinical research site cohort cost design dosage drug candidate experience first-in-human healthy volunteer insight method development mouse model novel novel therapeutic intervention novel therapeutics parent grant phase 1 study phase I trial prevent small molecule therapeutic candidate trial design

项目摘要

Abstract This application requests supplemental funds for the funded grant, 1 R01 AG074447-01, which supports a first-in-human clinical trial of CMS121, a drug candidate for treatment of Alzheimer's Disease. Since the date of submission of the application for the parent grant, modifications have become necessary. Two of the modifications optimize the information obtained from the trial and the third provides an NIA-mandated Data and Safety Monitoring Board (DSMB). These modifications were unanticipated at the time of submission of the parent grant application. Celerion's clinical trial budget has been amended primarily to address the additional costs associated with shifting the elderly cohort from the single ascending dose (SAD) protocol to the multiple ascending dose (MAD) protocol, a change that provides multiple advantages. Celerion's separate budget for methods development now includes additional costs due to the necessity for an additional protocol to provide accurate measurements of CMS121 and three CMS metabolites in plasma and urine. Another unanticipated increase in costs results from the NIA requirement that a DSMB be established for all clinical trials funded by NIA, including Phase I trials. The major enhancement in the trial design and the necessary improvement in the measurements CMS121 and CMS121 metabolites in plasma and urine will provide valuable data that would otherwise be missed. Furthermore, these data will be directly relevant for the design of the next phase clinical trial for CMS121. The NIA-required DSMB will provide NIA staff additional oversight of the trial's progress.

摘要