原始来源记录
重大临床试验登记变更
Cognition Therapeutics与FDA就zervimesine用于DLB精神病症状的关键性研究达成一致
FDA同意DLB精神病症状可作为可批准的适应症，并在3期注册性试验设计的关键方面达成一致。该研究将随机分配伴有幻觉/妄想的DLB患者接受100 mg zervimesine或安慰剂治疗9个月，以NPI为主要终点。试验预计于2027年年中启动。
关键事实
- 申报时间
- 2026年6月24日 11:39
- 事件
- 临床试验登记变更
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
来源摘录
EX-99.1 2 tm2618699d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Cognition Therapeutics Aligns on Key Aspects of Pivotal Study for Zervimesine (CT1812) in DLB Psychosis Following Receipt of FDA Meeting Minutes - Zervimesine Would be the First Long-term, Durable Treatment Option with an Impact on Underlying Disease - - Company Developing NPI as a Measure of DLB Psychosis - PURCHASE, NY – June 24, 2026 – Cognition Therapeutics, Inc. , (the “Company” or “Cognition”) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerative disorders, today announced that it received written feedback from the U.S. Food and Drug Administration (FDA) following its recent meeting. The FDA agreed that psychosis associated with dementia with Lewy bodies (DLB) could be an app