drugset / Trial / NCT05686239

A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)

NCT05686239 ↗

Phase 2 Completed 242 enrolled Recognify Life Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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: 1. Does RL-007 improve subjects performance in a set of cognitive tasks? 2. Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance? 3. How well do subjects tolerate RL-007? 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.

Timeline

Start
2022-12-08
Primary completion
2025-04-09
Completion
2025-04-09

Drugs

EvaluationDrugModalityDoseRoute
Subject 2-AMINO-3-HYDROXY-3-(PYRIDIN-4-YL)-1-(PYRROLIDIN-1-YL)PROPAN-1-ONE, (2R,3S)- Small molecule 20 mg Oral
Subject 2-AMINO-3-HYDROXY-3-(PYRIDIN-4-YL)-1-(PYRROLIDIN-1-YL)PROPAN-1-ONE, (2R,3S)- Small molecule 40 mg Oral