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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
611
One tablet of 10 mg iclepertin taken once daily for 26 weeks
One tablet of matching placebo taken once daily for 26 weeks
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
Change From Baseline in the 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
The change from baseline in MCCB (MATRICS Consensus Cognitive Battery) overall composite T-score at Week 26 is reported. This was analyzed using a mixed-effects model for repeated measurements (MMRM) comparing the change from baseline in MCCB overall composite T-score at Week 26 between iclepertin 10 mg daily and placebo. The MCCB comprises 10 tests to measure cognitive performance in 7 cognitive domains: speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite T-score is derived from the 7 cognitive domain T-scores. The T-score is standardized to the normative population with a mean of 50 and standard deviation of 10. A higher MCCB overall composite T-score indicates better cognition.
Time frame: The MMRM model is a longitudinal analysis which incorporated values at screening, baseline and at Week 12 and Week 26. The data presented here represent the Least Squares Mean at Week 26.
Change From Baseline in SCoRS (Schizophrenia Cognition Rating Scale) Interviewer Total Score 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, ranging from "No impairment" to "Severe Impairment", with higher ratings reflecting a greater degree of impairment. The SCoRS rater integrates information from separate patient and study partner interviews to generate a total score. SCoRS total score is between 20 and 80 where higher score values represent greater degree of impairment in day-to-day functions due to cognitive deficits. The total score was the sum of the 20 item scores. If six or more of the 20 items were missing, the total score was not derived and treated as missing for that participant at the visit, otherwise, missing items were imputed with the mean of the observed items for the purpose of total score calculation.
Time frame: The MMRM model is a longitudinal analysis which incorporated values at screening, baseline and at Week 12 and Week 26. The data presented here represent the Least Squares Mean at Week 26.
Change From Baseline in VRFCAT (Virtual Reality Functional Capacity Assessment Tool) Adjusted Total Time T-score at Week 26
The VRFCAT is a virtual reality shopping trip performed on a tablet. The task has several linked and sequential scenarios, including matching a recipe to the content of kitchen cabinets, preparing a shopping list, taking the correct bus, shopping efficiently, and catching the correct return bus. These tasks are performed in a fixed sequence. The tool records the total amount of time taken to complete the sequence of tasks, adjusting for number of errors and forced progressions. A T-score is generated from this adjusted total time. The lower the adjusted total time T-score, the better is the patient's functional capacity. The T-score has a mean of 50 and a standard deviation of 10 in the normative population.
Time frame: The MMRM model is a longitudinal analysis which incorporated values at screening, baseline and at Week 12 and Week 26. The data presented here represent the Least Squares Mean at Week 26.
Change From Screening Visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score
The Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) score evaluates how cognitive difficulties impact the daily life of individuals with schizophrenia. It is composed of 28 items on a 5-category Likert scale (1=not at all/not at all hard, 5=very much/very hard), and the total score was derived by calculating the average score of the first 26 items, where higher scores indicate a worse patient experience. The questionnaire takes 5-15 minutes to complete and provides insights into cognitive impairment associated with schizophrenia (CIAS) impact.
Time frame: The MMRM model is a longitudinal analysis which incorporated values at screening, and at Week 15 and Week 24. The data presented here represent the Least Squares Mean at Week 24.
Change From Baseline in the T-score of the Number of Correct Responses on Tower of London (ToL) at Week 26
Change from baseline in the T-score of the number of correct responses on Tower of London at Week 26, using an analysis of covariance (ANCOVA) model, is reported. The Tower of London evaluates executive functions such as reasoning and problem-solving ability. It measures the number of correct responses in solving an exercise that involves moving colored balls to match a target configuration. The higher the ToL T-score, the better is the patient's cognitive function. A mean T-score of 50 and a standard deviation of 10 reflects the T-score in the normative population. The administration time was about 7 minutes.
Time frame: Baseline and at Week 26
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Collaborative Neuroscience Research, LLC-Torrance-69527
Torrance, California, United States
Connecticut Mental Health Center
New Haven, Connecticut, United States
Research in Miami Inc
Hialeah, Florida, United States
Optimus U Corporation-Miami-69452
Miami, Florida, United States
Health Synergy Clinical Research, LLC
West Palm Beach, Florida, United States
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