Xanomeline and trospium chloride Improves Cognition in Schizophrenia With Baseline Impairments, reveals study
Xanomeline and trospium chloride (KarXT), a novel M1/M4 muscarinic receptor agonist, significantly improves cognitive performance among patients with schizophrenia who have baseline cognitive impairments. This was reported by a recent study published in The American Journal of Psychiatry conducted by William P. and fellow researchers.
Earlier work, including a phase 2 trial, established that xanomeline/trospium enhances cognitive measures in a subgroup of patients who enter the trial with clinically significant baseline cognitive impairments. Phase 3 trials, recently completed, validated this observation and established xanomeline/trospium as a targeted therapy for cognitive impairment in schizophrenia, even though its established efficacy remains as an antipsychotic medication.
Methods
Data from two 5-week inpatient phase 3 trials were analyzed. These trials evaluated the efficacy of xanomeline/trospium as monotherapy in patients with acute schizophrenia. The primary endpoint was the Positive and Negative Syndrome Scale (PANSS) total score. To evaluate cognitive benefit, the statistical analysis plan included comparisons of changes in cognitive composite score between xanomeline/trospium and placebo in two groups: the full sample (N = 357) and a subgroup with clinically significant baseline cognitive impairment, defined as scores ≤1 SD below norms at baseline. Additional analyses examined the effect size in subgroups with more severe cognitive impairment (≤−1.5 SD).
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