Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Iclepertin; Drug: Placebo

• Registration Number: NCT04846881
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-15
• Study Start: 2021-08-24
• Primary Completion: 2024-10-18
• Study Completion: 2024-11-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 611

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iclepertin	Iclepertin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	at baseline and at week 26	MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition

Secondary Outcome Measures

Name	Time	Method
Change from baseline to Week 26 in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)	at baseline and at week 26
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test	at baseline and at week 26
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score	up to 24 weeks	PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment	at baseline and at week 26	SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.

Trial Locations

Locations (127)

Research in Miami Inc; 🇺🇸 Hialeah, Florida, United States

Salem VA Medical Center; 🇺🇸 Salem, Virginia, United States

Benito Menni Complejo Asistencial en Salud Mental; 🇪🇸 Sant Boi de Llobregat, Spain

Clinical Innovations, Inc; 🇺🇸 Bellflower, California, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

ASCLEPES Research Centers, P.C. dba Alliance Research; 🇺🇸 Long Beach, California, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

Collaborative Neuroscience Research, LLC-Torrance-69527; 🇺🇸 Torrance, California, United States

Connecticut Mental Health Center; 🇺🇸 New Haven, Connecticut, United States

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