An adaptive, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of RL-007 in the treatment of cognitive impairment associated with schizophrenia (CIAS)

Conditions

Cognitive disorder, Schizophrenia

Brief summary

Change from baseline to Week 6 in: The MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score

Detailed description

Change from baseline to Week 6 in: • The Symbol Coding task from the MCCB •The Speed of Processing domain of the MCCB • The Attention/Vigilance domain of the MCCB • The Working Memory domain of the MCCB • The Verbal Memory domain of the MCCB • The Visual Learning domain of the MCCB • The Reasoning and Problem solving domain of the MCCB • Clinical Global Impression – Severity (CGI-S), TEAEs: From the randomization visit through the final follow up assessment on Week 8., Vital signs (blood pressure, heart rate [HR], respiratory rate, and temperature): Randomization (baseline), and Weeks 3 and 6., Physical examinations: Randomization (baseline) and Weeks 3 and 6., ECGs: Screening (baseline) and Week 6., Clinical laboratory tests [hematology, serum chemistry and urinalysis]: Randomization (baseline) and Week 6., C-SSRS: Randomization (baseline) and Weeks 3 and 6., Change from baseline in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) at Week 6, The Social Cognition domain of the MCCB

Related papers

No related papers found yet.

Interventions

DRUGPlacebo to RL-007

DRUGRL-007

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline to Week 6 in: The MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite score	—

Secondary

Measure	Time frame
Change from baseline to Week 6 in: • The Symbol Coding task from the MCCB •The Speed of Processing domain of the MCCB • The Attention/Vigilance domain of the MCCB • The Working Memory domain of the MCCB • The Verbal Memory domain of the MCCB • The Visual Learning domain of the MCCB • The Reasoning and Problem solving domain of the MCCB • Clinical Global Impression – Severity (CGI-S), TEAEs: From the randomization visit through the final follow up assessment on Week 8., Vital signs (blood pressure, heart rate [HR], respiratory rate, and temperature): Randomization (baseline), and Weeks 3 and 6., Physical examinations: Randomization (baseline) and Weeks 3 and 6., ECGs: Screening (baseline) and Week 6., Clinical laboratory tests [hematology, serum chemistry and urinalysis]: Randomization (baseline) and Week 6., C-SSRS: Randomization (baseline) and Weeks 3 and 6., Change from baseline in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) at Week 6, The Social Cognition domain	—

Measure

Time frame

Change from baseline to Week 6 in: • The Symbol Coding task from the MCCB •The Speed of Processing domain of the MCCB • The Attention/Vigilance domain of the MCCB • The Working Memory domain of the MCCB • The Verbal Memory domain of the MCCB • The Visual Learning domain of the MCCB • The Reasoning and Problem solving domain of the MCCB • Clinical Global Impression – Severity (CGI-S), TEAEs: From the randomization visit through the final follow up assessment on Week 8., Vital signs (blood pressure, heart rate [HR], respiratory rate, and temperature): Randomization (baseline), and Weeks 3 and 6., Physical examinations: Randomization (baseline) and Weeks 3 and 6., ECGs: Screening (baseline) and Week 6., Clinical laboratory tests [hematology, serum chemistry and urinalysis]: Randomization (baseline) and Week 6., C-SSRS: Randomization (baseline) and Weeks 3 and 6., Change from baseline in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) at Week 6, The Social Cognition domain

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Countries

Bulgaria, Czechia, Poland

Outcome results

None listed