Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)
NCT04846881 · View on ClinicalTrials.gov ↗
Study Summary
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Iclepertin
Study Locations (20)
California
- Clinical Innovations, Inc — Bellflower
- ATP Clinical Research, Inc. — Costa Mesa
- ASCLEPES Research Centers, P.C. dba Alliance Research — Long Beach
- University of California Los Angeles — Los Angeles
- NRC Research Institute — Orange
- Collaborative Neuroscience Research, LLC-Torrance-69527 — Torrance
Florida
- Research in Miami Inc — Hialeah
- Optimus U Corporation-Miami-69452 — Miami
- Health Synergy Clinical Research, LLC — West Palm Beach
New York
- Neurobehavioral Research, Inc. — Cedarhurst
- New York State Psychiatric Institute — New York
Texas
- Relaro Medical Trials, LLC — Dallas
- John Peter Smith Health Network — Fort Worth
Connecticut
- Connecticut Mental Health Center — New Haven
Illinois
- American Medical Research — Chicago
Maryland
- Sheppard Pratt Physicians's Practice Association, Inc. — Baltimore
Missouri
- PsychCare Consultants Research — St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 611 participants |
| Start Date | 2021-08-24 |
| Est. Completion | 2024-11-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04846881
The ClinicalTrials.gov registry entry for NCT04846881 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 611 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04846881 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04846881 about?
NCT04846881 is a clinical study titled "Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)". This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or pla...
What is the current status of trial NCT04846881?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 611 participants. The study started on 2021-08-24. Estimated completion is 2024-11-17.
What conditions does trial NCT04846881 study?
This clinical trial studies the following conditions: Schizophrenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04846881?
The interventions under investigation include: Placebo (DRUG), Iclepertin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04846881?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04846881 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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