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The CONNEX programme comprised three multicentre, randomized, double-blind, placebo-controlled phase 3 trials conducted at 338 psychiatric centres in 41 countries to evaluate iclepertin for cognitive impairment associated with schizophrenia. Adults aged 18–50 years received oral iclepertin 10 mg once daily or placebo alongside standard antipsychotic treatment for 26 weeks. Across the programme, 1,835 patients received treatment: 918 in the iclepertin group and 917 in the placebo group; 1,602 completed treatment. The primary endpoint was change from baseline in the MATRICS Consensus Cognitive Battery overall composite T-score at week 26. The adjusted mean difference between iclepertin and placebo was 0.127 (95% CI, −0.396 to 0.650; p=0.63), indicating no statistically significant improvement in cognition. The primary endpoint and key secondary endpoints were not met in the individual trials or pooled population. Adverse events occurred in 66% of patients receiving iclepertin and 69% receiving placebo; one death occurred in the placebo group and was considered unrelated to treatment. The authors concluded that iclepertin was generally well tolerated but did not significantly improve cognition, highlighting the difficulty of developing effective pharmacological treatments for cognitive impairment in schizophrenia.
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The CONNEX programme comprised three multicentre, randomized, double-blind, placebo-controlled phase 3 trials conducted at 338 psychiatric centres in 41 countries to evaluate iclepertin for cognitive impairment associated with schizophrenia. Adults aged 18–50 years received oral iclepertin 10 mg once daily or placebo alongside standard antipsychotic treatment for 26 weeks. Across the programme, 1,835 patients received treatment: 918 in the iclepertin group and 917 in the placebo group; 1,602 completed treatment. The primary endpoint was change from baseline in the MATRICS Consensus Cognitive Battery overall composite T-score at week 26. The adjusted mean difference between iclepertin and placebo was 0.127 (95% CI, −0.396 to 0.650; p=0.63), indicating no statistically significant improvement in cognition. The primary endpoint and key secondary endpoints were not met in the individual trials or pooled population. Adverse events occurred in 66% of patients receiving iclepertin and 69% receiving placebo; one death occurred in the placebo group and was considered unrelated to treatment. The authors concluded that iclepertin was generally well tolerated but did not significantly improve cognition, highlighting the difficulty of developing effective pharmacological treatments for cognitive impairment in schizophrenia.
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