A Study of KYN-5356 for Cognitive Impairment in Schizophrenia

This study is testing KYN-5356, an oral tablet, to see if it can improve thinking and memory problems (cognitive impairment) in adults with schizophrenia. We are looking for 150 adults, aged 18 to 55, who have been diagnosed with schizophrenia for at least one year and are currently stable on their antipsychotic medication. Participants will receive either KYN-5356 at a low, medium, or high dose, or a placebo (an inactive tablet). The main goal is to see how well KYN-5356 works on cognitive function after 28 days. The study's current status is unclear.

Study design
This is a Phase 2 study with 150 participants. It is randomized, meaning you would be assigned to a treatment group by chance, and double-blind, meaning neither you nor the study team will know which treatment you are receiving.
What's involved
You would be admitted to a clinic for 32 days, staying there from 3 days before treatment starts until the end of the 28-day treatment period. During this time, you would take the study medication daily.
Compensation
Not stated in the trial record.
Follow-up
The main effects on cognitive function are measured at 28 days, which is the end of the treatment period.

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NCT07191483

A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia

Recruiting
PHASE2Ages 18–55InterventionalTreatment
Kynexis B.V.
~150 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:KYN-5356 low dosePlaceboKYN-5356 Medium DoseKYN-5356 High Dose

At a glance

Recruiting sites
14 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)
Measured over 28 days
Cognitive Impairment Associated With Schizophrenia (CIAS)
15 sites across 10 states
California3
Florida3
Georgia2
Arkansas1
Illinois1
Maryland1
Missouri1
New Jersey1

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Eligibility criteria

Inclusion

Has an established primary psychiatric diagnosis of schizophrenia
Clinically stable and in the residual (nonacute) phase of their illness for at least 8 weeks before screening in the judgement of the investigator
Diagnosis of schizophrenia for at least 1 year before screening
Must be in ongoing maintenance antipsychotic monotherapy on a stable medication treatment regimen for ≥ 2 months before screening, including concomitant psychotropic medications.
Male or female, aged ≥18 and ≤55 years
Has a body mass index (BMI) between 18 and 40 kg/m2 Inclusive
Must exhibit capability to comply with all protocol procedures in the judgement of the investigator
Signed and dated written informed consent before screening in accordance with Good Clinical Practice.

Exclusion

Currently being treated with more than 1 antipsychotic at the time of screening,
A score of 2 or higher on any of the individual items of the Modified Simpson-Angus Scale (mSAS) at screening
Moderate to severe substance use disorder (other than nicotine or caffeine, but including alcohol)
Evidence of unstable medical condition
  • To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS)28 days

    Change from Baseline at Day 28 in the digital version of the Brief Assessment of Cognition for Schizophrenia (BAC App) composite T-score