Combining Pharmacotherapy of Iclepertin (BI 425809) With Computerized Cognitive Training in Patients With Schizophrenia: Baseline Data and Patient Demographics From an Ongoing Phase II Trial

Abstract: Introduction Iclepertin (BI 425809), a novel glycine transporter-1 inhibitor, had pro-cognitive effects in patients with schizophrenia in a Phase II trial; however, the effects of concurrent cognitive stimulation are unknown. We present preliminary demographics and baseline data exploring efficacy of iclepertin with at-home computerized cognitive training (CCT). Methods In this ongoing Phase II, double-blind, placebo-controlled, parallel-group trial, patients with schizophrenia are recruited (58 centers, 6 countries) and randomized (1:1) to receive iclepertin 10 mg or placebo with CCT daily for 12 weeks. Primary endpoint: change from baseline (CfB) in neurocognitive composite T-score of the MATRICS Consensus Cognitive Battery (MCCB). Secondary endpoints: CfB in the Schizophrenia Cognition Rating Scale (SCoRS) total score, MCCB overall composite T-score, Positive and Negative Syndrome Scale (PANSS) total score and adverse events. Novel exploratory endpoints: Virtual Reality Functional Capacity Assessment Tool and the Balloon Effort Task to assess functioning and motivation. Results The treated population currently includes 183 patients: 67% male (n=122) and mean (standard deviation [SD]) age and time since first diagnosis are 38.2 (7.9) and 13.5 (8.5) years. Mean (SD) baseline MCCB neurocognitive composite and overall T-scores (n=178) are 33.7 (11.9) and 32.5 (12.6). Mean (SD) baseline SCoRS total score (n=167) is 35.2 (8.7). Mean (SD) baseline PANSS total and negative symptom scale scores (n=183) are 64.7 (14.6) and 17.3 (5.4). The median (Q1, Q3) CCT compliance over the on-treatment period is 2 (1.21, 2.51) hours/week. Conclusions This trial will demonstrate if iclepertin with concurrent CCT enhances cognitive benefit and improves functioning.Short Description: This trial is, to our knowledge, the largest of its kind to combine pharmacotherapy with computerized cognitive training (CCT) to treat cognitive impairment associated with schizophrenia. Presented are the preliminary demographics and baseline data exploring efficacy of iclepertin (BI 425809; a novel glycine transporter-1 inhibitor) with at-home CCT. Data from this trial will demonstrate the effects of iclepertin (10 mg) in patients with schizophrenia who are also participating in CCT.Name of Sponsoring Organization(s): Boehringer Ingelheim International GmbH