MedTrace Logo

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

NCT05686239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

RL-007 (Inidascamine)

investigational study drug

DRUG

Placebo

placebo capsules matching the appearance and size of the active drug

Sponsors & Collaborators

  • Recognify Life Sciences

    lead INDUSTRY

Principal Investigators

  • Gary Walker, PhD · Recognify Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-08
Primary Completion
2025-04-09
Completion
2025-04-09
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • Poland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05686239 on ClinicalTrials.gov