What side effects are associated with this type of intervention?

Common treatments for schizophrenia primarily include antipsychotic medications. First-generation antipsychotics, like haloperidol, are associated with extrapyramidal symptoms (EPS) such as akathisia, dystonia, and parkinsonism. Second-generation antipsychotics, like risperidone and olanzapine, tend to cause fewer EPS but can lead to weight gain, metabolic syndrome, and sedation. Clozapine, another second-generation antipsychotic, is more effective but has significant risks including agranulocytosis and requires regular blood monitoring. Cognitive enhancers like Iclepertin, aimed at improving learning and memory, are still under investigation, and their side effect profiles are not yet fully established.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, including both first-generation (typical) and second-generation (atypical) antipsychotics. Examples of second-generation antipsychotics include aripiprazole, risperidone, quetiapine, and clozapine, which are often preferred due to their improved side effect profiles. While these medications primarily target psychotic symptoms, some, like aripiprazole, have shown potential benefits in cognitive function. However, there are limited FDA-approved treatments specifically aimed at cognitive enhancement in schizophrenia. Iclepertin, currently under study, represents a novel approach focusing on improving learning and memory in schizophrenia patients.

What other types of research exist?

Promising novel alternatives to Iclepertin for improving learning and memory in schizophrenia patients include: 1) Lumateperone, a novel antipsychotic with potential cognitive benefits, 2) SEP-363856, a non-D2-receptor-binding antipsychotic showing promise in early trials, and 3) Cognitive remediation therapy (CRT), a non-pharmacological approach that has shown efficacy in enhancing cognitive functions in schizophrenia patients.

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Iclepertin for Schizophrenia

Phase 3

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.

Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) with the following clinical features: Outpatient, clinically stable and in the residual (non-acute) phase of their illness. No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization. Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement.

Must not have

Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia or epilepsy.

-- Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at week 26

Awards & highlights

Pivotal Trial

Summary

This trial tests if a medicine called Iclepertin can help improve memory and learning in adults with schizophrenia. Participants take Iclepertin daily while continuing their usual medication. Doctors regularly check their mental abilities and health throughout the study. Iclepertin is being studied for its potential to improve cognitive functions in schizophrenia.

Who is the study for?

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), and experiencing functional impairment in daily activities can join. They must not have been hospitalized for worsening schizophrenia recently, use effective birth control if applicable, and have a study partner who meets regularly.

What is being tested?

The trial tests Iclepertin's effect on cognitive functions like learning and memory in people with schizophrenia over 26 weeks. Participants are randomly assigned to receive either Iclepertin or a placebo alongside their standard medication while undergoing regular mental ability assessments.

What are the potential side effects?

While the specific side effects of Iclepertin are not listed here, participants will be monitored for any unwanted effects throughout the study. Common drug-related side effects could include nausea, headaches, dizziness or sleep disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been on the same antipsychotic medication for at least 12 weeks.

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I have schizophrenia, am stable, and struggle with daily activities.

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I take no more than 1 mg of lorazepam or its equivalent daily.

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I am using or willing to use effective birth control and agree to pregnancy tests.

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I am between 18 and 50 years old.

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I haven't been hospitalized or needed more psychiatric care for my schizophrenia in the last 12 weeks.

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I've been on 1 or 2 antipsychotics (not clozapine) for over 12 weeks and on the same dose for at least 35 days.

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I take 1 mg or less of lorazepam-equivalent daily.

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I meet with my study partner at least once a week in person.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have cognitive issues due to a condition like epilepsy, stroke, or head injury.

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My side effects from antipsychotic medication can't be managed with low-dose treatments.

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I am not taking clozapine.

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I have used ketamine or esketamine.

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I have not undergone electroconvulsive therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and at week 26

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and at week 26

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and at week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment

Secondary study objectives

Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment

Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test

Change from baseline to Week 26 in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

+1 more

Side effects data

From 2019 Phase 2 trial • 611 Patients • NCT02788513

Headache

Nausea

Dizziness

Fall

Nasopharyngitis

Atrial flutter

Pancreatitis acute

Transient ischaemic attack

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

2 mg BI 425809

5 mg BI 425809

10 mg BI 425809

25 mg BI 425809

Placebo Group

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IclepertinExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iclepertin

2024

Completed Phase 1

~60

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia primarily involve antipsychotic medications, which are divided into typical and atypical antipsychotics. Typical antipsychotics, such as haloperidol, primarily work by blocking dopamine D2 receptors, which helps reduce positive symptoms like hallucinations and delusions. Atypical antipsychotics, such as clozapine and risperidone, also target dopamine receptors but additionally affect serotonin receptors, which can help with both positive and negative symptoms. The importance of these mechanisms lies in their ability to manage the core symptoms of schizophrenia, thereby improving patients' quality of life. Cognitive enhancers like Iclepertin, which are being studied for their potential to improve learning and memory, represent a novel approach that could address cognitive deficits in schizophrenia, an area not adequately targeted by traditional antipsychotics.

A meta-analysis and critical review of the effects of conventional neuroleptic treatment on cognition in schizophrenia: opening a closed book.Treatments for schizophrenia: a critical review of pharmacology and mechanisms of action of antipsychotic drugs.Cognitive improvement in schizophrenia with novel antipsychotic medications.