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

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.