Clinical Trial of BI 425809 Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-2)
Status:
Recruiting
Trial end date:
2024-05-03
Target enrollment:
Participant gender:
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 BI 425809 improves learning and memory in
people with schizophrenia.
Participants are put into two groups randomly, which means by chance. One group takes BI
425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809
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.