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The goal of this clinical trial is to evaluate if the investigational drug, RL-007, can improve the cognitive performance of subjects with schizophrenia. The main questions the study aims to answer are:
In the study, subjects will perform the cognitive tasks at the beginning to get familiar with the tasks. Then, subjects will be given either RL-007 or a placebo for 6 weeks and then repeat the cognitive tasks. The researchers will compare the results at the end of the treatment period to the baseline to see if there have been any changes in performance.
Additionally, several safety measures will be collected throughout the study (blood pressure, physical exam, ECGs, etc) to evaluate if there are any side effects from taking RL-007.
This is a randomized, 3-arm, placebo-controlled, double-blinded clinical trial to evaluate the efficacy, safety, and tolerability of RL-007 in subjects with stable schizophrenia. The treatment period is 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RL-007 20 mg (Inidascamine) | Experimental | oral dosing three times per day (TID) |
|
| RL-007 40 mg (Inidascamine) | Experimental | oral dosing three times per day (TID) |
|
| Placebo | Placebo Comparator | oral dosing three times per day (TID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RL-007 (Inidascamine) | Drug | investigational study drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite | change from baseline in composite of nine cognitive tests | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Symbol Coding | change from baseline | 6 weeks |
| The Speed of Processing domain of the MCCB | change from baseline | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures | Treatment Emergent Adverse Events | 6 weeks |
| The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) | change from baseline |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Walker, PhD | Recognify Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recognify Research Site | Culver City | California | 90230 | United States | ||
| Collaborative Neuroscience Research |
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| Placebo | Drug | placebo capsules matching the appearance and size of the active drug |
|
| The Attention/Vigilance domain of the MCCB | change from baseline | 6 weeks |
| The Working Memory domain of the MCCB | change from baseline | 6 weeks |
| The Verbal Memory domain of the MCCB | change from baseline | 6 weeks |
| The Visual Learning domain of the MCCB | change from baseline | 6 weeks |
| The Reasoning and Problem-solving domain of the MCCB | change from baseline | 6 weeks |
| Clinical Global Impression - Severity (CGI-S) | change from baseline | 6 weeks |
| 6 weeks |
| The Social Cognition domain of the MCCB | change from baseline | 6 weeks |
| Garden Grove |
| California |
| 92845 |
| United States |
| Recognify Research Site | Lafayette | California | 94549 | United States |
| Recognify Research Site | Oceanside | California | 92056 | United States |
| Recognify Research Site | Orange | California | 92868 | United States |
| Recognify Research Site | Torrance | California | 90502 | United States |
| Recognify Research Site | Hialeah | Florida | 33016 | United States |
| Recognify Research Site | Miami | Florida | 33135 | United States |
| Recognify Research Site | Miami Lakes | Florida | 33016 | United States |
| Recognify Research Site | Atlanta | Georgia | 30030 | United States |
| Recognify Research Site | Augusta | Georgia | 30912 | United States |
| Recognify Research Site | Gaithersburg | Maryland | 20877 | United States |
| Recognify Research Site | Berlin | New Jersey | 08009 | United States |
| Recognify Research Site | Brooklyn | New York | 11235 | United States |
| Recognify Research Site | Chapel Hill | North Carolina | 27599 | United States |
| Recognify Research Site | Cincinnati | Ohio | 45219 | United States |
| Recognify Research Site | Cleveland | Ohio | 44122 | United States |
| Recognify Research Site | Dallas | Texas | 75231 | United States |
| Recognify Research Site | Houston | Texas | 77074 | United States |
| Recognify Research Site | Everett | Washington | 98201 | United States |
| Recognify Research Site | Burgas | Bulgaria |
| Recognify Research Site | Kardzhali | Bulgaria |
| Recognify Research Site | Pleven | Bulgaria |
| Recognify Research Site | Plovdiv | Bulgaria |
| Recognify Research Site | Sofia | Bulgaria |
| Recognify Research Site (a) | Varna | Bulgaria |
| Recognify Research Site (b) | Varna | Bulgaria |
| Recognify Research Site | Pilsen | Czechia |
| Recognify Research Site (a) | Prague | Czechia |
| Recognify Research Site (b) | Prague | Czechia |
| Recognify Research Site | Gdansk | Poland |
| Recognify Research Site | Gorlice | Poland |
| Recognify Research Site | Kielce | Poland |
| Recognify Research Site | Lodz | Poland |
| Recognify Research Site | Lublin | Poland |
| Recognify Research Site | Poznan | Poland |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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