What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly second-generation antipsychotics such as aripiprazole and risperidone, are associated with side effects including weight gain, metabolic syndrome, and extrapyramidal symptoms like tremors and rigidity. Cognitive enhancers like Iclepertin, which are being studied for their potential to improve learning and memory, may have different side effect profiles that are not yet fully understood. However, regular monitoring for any adverse effects is crucial in clinical trials to ensure patient safety.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, primarily focusing on managing psychotic symptoms rather than cognitive enhancement. These include first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation antipsychotics such as risperidone, olanzapine, quetiapine, and aripiprazole. While these medications are effective in reducing symptoms like hallucinations and delusions, they do not specifically target cognitive deficits. There is limited information on FDA-approved drugs specifically aimed at cognitive enhancement in schizophrenia, making Iclepertin a potentially novel approach in this area.

What other types of research exist?

Promising novel alternatives to Iclepertin for cognitive enhancement in schizophrenia patients include: <ol> <li>Lumateperone: A newer antipsychotic with potential cognitive benefits.</li> <li>Encenicline: A nicotinic receptor agonist under investigation for cognitive improvement.</li> <li>BI 425809: A glycine transporter-1 inhibitor showing promise in enhancing cognitive function.</li> <li>SEP-363856: A novel antipsychotic with potential cognitive benefits, currently in clinical trials.</li> <li>Cognitive Remediation Therapy (CRT): Non-pharmacological intervention aimed at improving cognitive deficits in schizophrenia.</li> </ol>

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Iclepertin for Schizophrenia

Phase 3

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Male or female patients who are 18-50 years (inclusive) of age at time of consent.

Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).

Must not have

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

Patients who were treated with any of the following within 6 months prior to randomization: Clozapine, Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil), Ketamine or esketamine, Electroconvulsive therapy (ECT) or modified ECT Further exclusion criteria apply.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and at week 26

Awards & highlights

Pivotal Trial

Summary

This trial tests if a daily pill called Iclepertin can improve learning and memory in adults with schizophrenia. Participants take either Iclepertin or another pill for several months while continuing their usual medication. Doctors regularly check their mental abilities and overall health.

Who is the study for?

Adults aged 18-50 with schizophrenia, stable on current antipsychotic treatment (except clozapine), not hospitalized for worsening symptoms in the last 12 weeks. Must have a study partner and be capable of consent. Women must use effective birth control.

What is being tested?

The trial tests if Iclepertin improves cognition compared to placebo over 26 weeks. Participants also continue their usual schizophrenia medication, attend regular visits for health checks and cognitive assessments using questionnaires and computer tests.

What are the potential side effects?

Potential side effects are not specified in the provided information but generally could include typical drug-related reactions such as nausea, headaches, dizziness or other unexpected issues that will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 50 years old.

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I have been diagnosed with schizophrenia according to DSM-5.

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I am between 18 and 50 years old.

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My schizophrenia symptoms are moderate based on specific PANSS scores.

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I've been on 1 or 2 antipsychotic drugs, except clozapine, for over 12 weeks.

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

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I am between 18 and 50 years old.

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I am between 18 and 50 years old.

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I am between 18 and 50 years old.

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I am between 18 and 50 years old.

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I am between 18 and 50 years old.

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I am between 18 and 50 years old.

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I am between 18 and 50 years old.

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 stroke, head injury, dementia, or epilepsy.

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I haven't used specific medications like Clozapine or undergone treatments like ECT in the last 6 months.

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

Schizophrenia

Secondary study objectives

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

Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score

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 3

~1290

0 / 15Eligibility 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 include antipsychotic medications and cognitive enhancers. Antipsychotics work by blocking dopamine receptors, particularly the D2 receptor, to reduce symptoms like hallucinations and delusions. Cognitive enhancers, such as Iclepertin, aim to improve cognitive functions like learning and memory by targeting neurotransmitter systems like glutamate and acetylcholine. This focus on cognitive enhancement is crucial as cognitive deficits are a core feature of schizophrenia, significantly impacting daily functioning and quality of life.

A meta-analysis and critical review of the effects of conventional neuroleptic treatment on cognition in schizophrenia: opening a closed book.