Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
- Registration Number
- NCT04846868
- 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 and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 620
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iclepertin arm Iclepertin - Placebo arm 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 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.
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.
Trial Locations
- Locations (116)
Velocity Clinical Research-Santa Ana-68902
🇺🇸Santa Ana, California, United States
CCM Clinical Research Group, LLC-Miami-68482
🇺🇸Miami, Florida, United States
Richmond Behavioral Associates-Staten Island-68636
🇺🇸Staten Island, New York, United States
St. Paul's Hospital-Iloilo City-40765
🇵🇭Iloilo City, Philippines
Collaborative Neuroscience Network, LLC (CNS)
🇺🇸Garden Grove, California, United States
Omega Clinical Trials,LLC
🇺🇸La Habra, California, United States
Artemis Institute for Clinical Research, LLC
🇺🇸San Diego, California, United States
Institute of Living
🇺🇸Hartford, Connecticut, United States
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Atlanta Center
🇺🇸Atlanta, Georgia, United States
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