The Impact of Xanomeline and Trospium Chloride on Cognitive Impairment in Acute Schizophrenia: Replication in Pooled Data From Two Phase 3 Trials.

Objective: Xanomeline and trospium chloride (formerly known as KarXT), a novel M/M muscarinic receptor agonist, demonstrated efficacy across phase 2 and 3 trials as monotherapy for the treatment of inpatients with acute schizophrenia on the Positive and Negative Syndrome Scale total score primary endpoint. In the phase 2 trial, xanomeline/trospium improved performance on a cognitive outcome measure in the subgroup of participants with clinically significant baseline cognitive impairment. The authors sought to confirm this finding using data from two phase 3 trials.

Migration of digital functional capacity assessments from device resident to cloud-based delivery: Development and convergent validity.

Decentralized clinical trials are leading to rapid changes in assessment technology, including an expansion of interest in remote delivery. As technology changes, some of the updates include migration to fully cloud-based software and data management, with attendant differences in hardware, response modalities, and modifications in the level of tester engagement. It is rare to see systematic descriptions of the process of migration and upgrading of technology-related assessments.

Location-based differences in cognition and functional capacity: Consistent levels of impairment in participants with schizophrenia compared to healthy controls.

Cognitive performance manifests regional differences, correlated with education. There is less information available about regional differences in performance-based measures of functional capacity. In multi-national trials focused on cognitive enhancement, it may be impossible to validate every measure in all locations.