What side effects are associated with this type of intervention?

Common treatments for schizophrenia, particularly antipsychotic medications, often have side effects that include extrapyramidal symptoms (such as akathisia, dystonia, and parkinsonism), weight gain, metabolic syndrome, sedation, and increased risk of cardiovascular issues. Second-generation antipsychotics like aripiprazole and risperidone are preferred due to their relatively favorable side effect profiles compared to first-generation antipsychotics. Cognitive enhancers like Iclepertin, which are being studied for their potential to improve learning and memory, may have different side effects, but specific data on these are not provided in the context.

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. First-generation antipsychotics like haloperidol and chlorpromazine primarily target positive symptoms of schizophrenia. Second-generation antipsychotics, such as risperidone, olanzapine, quetiapine, and aripiprazole, are more commonly used today due to their broader efficacy and better side effect profiles. These medications primarily address positive and some negative symptoms but have limited effects on cognitive deficits. Cognitive enhancement in schizophrenia is an emerging area of research, with investigational drugs like iclepertin being studied for their potential to improve learning and memory in affected individuals.

What other types of research exist?

Promising novel alternatives to Iclepertin for cognitive enhancement in schizophrenia patients include: 1. Lumateperone: An atypical antipsychotic with potential cognitive benefits. 2. SEP-363856: A novel antipsychotic that has shown improvements in cognitive symptoms. 3. BI 425809: A glycine transporter-1 inhibitor currently in clinical trials for cognitive impairment in schizophrenia. 4. TAK-831: A D-amino acid oxidase inhibitor being studied for its cognitive enhancement effects. These alternatives are in various stages of research and may offer new options for cognitive enhancement in schizophrenia.

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Iclepertin for Schizophrenia

Verified Trial

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

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 26 weeks of treatment

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medicine called iclepertin to see if it can help adults with schizophrenia improve their learning and memory. Participants will take either the medicine or a non-active substance while continuing their regular medication. Doctors will regularly check their mental abilities and overall health over several months.

Who is the study for?

Adults aged 18-50 with schizophrenia, in a stable phase of their illness, can join this study. They need to have been hospitalization-free for the past 12 weeks and not exhibit uncontrolled symptoms. Women must use effective birth control, and all participants should have regular interaction with a study partner.

What is being tested?

The CONNEX-3 trial is testing if Iclepertin improves learning and memory in people with schizophrenia over placebo. Participants take either Iclepertin or placebo tablets daily for 26 weeks while continuing their usual medication, as mental abilities are assessed through tests.

What are the potential side effects?

While specific side effects of Iclepertin aren't listed here, participants' health will be monitored throughout the study to record any unwanted effects that may arise from taking the medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 26 weeks of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 26 weeks of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 26 weeks of treatment 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)

Secondary study objectives

Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score

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

Side effects data

From 2022 Phase 2 trial • 200 Patients • NCT03859973

Headache

Vomiting

Colitis

100%

80%

60%

40%

20%

Study treatment Arm

BI 425809 10 mg + Computerized Cognitive Training

Placebo + Computerized Cognitive Training

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: Iclepertin treatment groupExperimental Treatment1 Intervention

Group II: Placebo groupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 425809

2019

Completed Phase 3

~1240

Do I qualify?Apply below to find out

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 include antipsychotic medications and cognitive enhancers. Antipsychotics work by blocking dopamine receptors, particularly the D2 receptor, to reduce psychotic symptoms like hallucinations and delusions. Cognitive enhancers, such as Iclepertin, aim to improve cognitive deficits by targeting neurotransmitter systems like glutamate or acetylcholine pathways. This focus on cognitive enhancement is important because cognitive impairments in schizophrenia significantly affect daily functioning and quality of life.

[Diagnosis and treatment of motor phenomena in schizophrenia spectrum disorders].A meta-analysis and critical review of the effects of conventional neuroleptic treatment on cognition in schizophrenia: opening a closed book.