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 10 mg Iclepertin Patients with schizophrenia took orally once a day one 10 milligram (mg) tablet of iclepertin. Placebo-matching Iclepertin 10 mg Placebo Patients with schizophrenia took orally once a day one tablet of placebo-matching iclepertin.
- 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 MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported. 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. The larger the MCCB overall composite T-score, the better patient cognition. A mean T-score of 50 and a standard deviation of 10 reflects the general population.
The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on on-treatment periods. On-treatment is defined as the period of first drug administration/first resumed dose after interruption until last drug administration + REP (residual effect period).
The change from baseline was analyzed with a MMRM (mixed-effects model for repeated measures) with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was the repeated measure.
- Secondary Outcome Measures
Name Time Method Key Secondary Endpoint: Change From Baseline in the Schizophrenia Cognition Rating Scale (SCoRS) Interviewer Total Score After 26 Weeks of Treatment MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported. The SCoRS is an interview based- assessment tool to evaluate the cognitive function of individuals with schizophrenia that incorporates the input of the patient, the caregiver and the interviewer. It is composed of 20 items on a 7-point Likert scale, ranging from 20 to 140 points, where a higher score indicates a greater cognitive impairment.
The estimated treatment effect included the effect of any concomitant therapies and partner change in SCoR assessment for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.
The change from baseline was analyzed with mixed-effects model for repeated measures (MMRM) with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure.Key Secondary Endpoint: Change From Baseline to Week 26 in the Adjusted Total Time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) MMRM included measurements at baseline, Week 12, and Week 26. Change from baseline values at Week 26 is reported. The VRFCAT is a computerized assessment measuring the functional capacity of an individual to perform everyday tasks. It generates a composite score based on the amount of time taken to complete the tasks. The lower the VRFCAT T-score, the better patient's functional capacity. A mean T-score of 50 and a standard deviation of 10 reflects the T-score in a general population.
The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.
The change from baseline was analyzed with MMRM with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure.Change From Screening Visit 1a in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) Total Score at Week 24 MMRM included measurements at Visit 1a (Week -2/Week -1), Week 15, and Week 24. Change from Visit 1a values at Week 24 is reported. 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 mean a worse patient experience.
The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.
The change from baseline was analyzed with MMRM with the fixed effects: treatment at each visit, stratification factor using the screening MCCB overall composite T-score, and baseline MCCB overall composite T-score at each visit. Visit was treated as the repeated measure.Change From Baseline in the T-score of the Number of Correct Responses on Tower of London at Week 26 At baseline and at Week 26. The Tower of London (ToL) evaluates executive functioning, reasoning, problem-solving, and goal-directed behavior. It measures the number of correct responses in solving an exercise that consists on moving colored balls to match a target configuration. The higher the ToL T-score, the better patient's cognitive function. A mean T-score of 50 and a standard deviation of 10 reflects the T-score in a general population.
The estimated treatment effect included the effect of any concomitant therapies for all randomized patients on-treatment. On-treatment is defined as the period of 1st drug administration/1st resumed dose after interruption until last drug administration + REP.
The change from baseline comparing the groups was analyzed using analysis of covariance (ANCOVA) model including treatment, stratification factor of screening MCCB overall composite T-score, and baseline number of correct responses on Tower of London T-score.Ocular Safety Sub-study: Humphrey Visual Field 24-2 Swedish Interactive Thresholding Algorithm (SITA) Standard At baseline and at Week 24. The Humphrey Visual Field 24-2 SITA Standard is a diagnostic test to measure visual fields, or perimetry. The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. During this test, lights of varying intensities appear in different parts of the visual field while the patient's eye is focused on a central spot. The perception of these lights is charted and then compared to results of a healthy eye at the same age of the patient to determine if any damage has occurred. The tests ranks from 0 to 100%, where 0 means no vision and 100 means perfect vision.
Ocular Safety Sub-study: Central Retinal Thickness as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) At baseline and at Week 24. The central retinal thickness for both eyes was measured by high-definition optical coherence tomography (spectral domain OCT), which evaluates the retinal and sub-retinal structures of both eyes.
Trial Locations
- Locations (116)
Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)
🇧🇷Belo Horizonte,Minas Gerais, Brazil
The Second People's Hospital of Hunan Province (Brain Hospital of Hunan Province)
🇨🇳Changsha, China
A.O.U. Senese
🇮🇹Siena, Italy
Japan Institute for Health Security National Kohnodai Medical Center
🇯🇵Chiba, Ichikawa, Japan
North Shore Hospital
🇳🇿Takpuna Auckland, New Zealand
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
Velocity Clinical Research-Santa Ana-68902
🇺🇸Santa Ana, California, United States
Institute of Living
🇺🇸Hartford, Connecticut, United States
Scroll for more (106 remaining)Hospital das Clinicas da Universidade Federal de Minas Gerais (HCUFMG)🇧🇷Belo Horizonte,Minas Gerais, Brazil