KYN-5356 for cognitive impairment in adults with schizophrenia
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With Schizophrenia
This Phase 2 trial will see if 28 days of KYN-5356 improves thinking and memory in adults with stable schizophrenia who have cognitive difficulties.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Kynexis B.V. Industry-sponsored |
| Locations | 13 sites (Little Rock, Arkansas and 12 other locations) |
| Trial ID | NCT07191483 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2 study assigns participants to placebo or one of three doses of KYN-5356 for 28 days. Participants are admitted to the clinic three days before dosing and remain in residence for 32 days for dosing, safety monitoring, and pharmacokinetic/pharmacodynamic sampling, with a follow-up visit on Day 42. A subset of participants at selected sites will undergo electrophysiological testing to evaluate neurophysiological changes. Efficacy, safety, PK/PD, and exploratory biomarkers will be compared across dose groups to explore dose-response and tolerability.
Who should consider this trial
Good fit: Adults aged 18–55 with a diagnosis of schizophrenia for at least one year, clinically stable in the nonacute phase, on single antipsychotic maintenance therapy for ≥2 months, and with BMI 18–40 are the intended participants.
Not a fit: People in an acute psychotic phase, those taking more than one antipsychotic, those with notable extrapyramidal signs (mSAS item ≥2), or those outside the age/BMI limits are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, KYN-5356 could improve cognitive symptoms such as memory, attention, or problem-solving, potentially helping daily functioning for people with schizophrenia.
How similar studies have performed: KYN-5356 appears to be a novel investigational drug for CIAS, and prior efforts to improve cognition in schizophrenia have produced mixed or modest results, so clinical benefit here is unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Little Rock, Arkansas and 12 other locations
- Woodland International Research Group — Little Rock, Arkansas, United States (Recruiting)
- Synergy Research Center — Lemon Grove, California, United States (Recruiting)
- Cenexel CNS — Los Alamitos, California, United States (Recruiting)
- Cenexel RCA — Hollywood, Florida, United States (Recruiting)
- Segal Trials — Miami Lakes, Florida, United States (Recruiting)
- Cenexel ACMR — Atlanta, Georgia, United States (Recruiting)
- Cenexel iResearch Atlanta — Decatur, Georgia, United States (Recruiting)
- Uptown Research Institute — Chicago, Illinois, United States (Recruiting)
- Cenexel CBH — Gaithersburg, Maryland, United States (Recruiting)
- Arch Clinical Trials — St Louis, Missouri, United States (Recruiting)
- Cenexel HRI — Marlton, New Jersey, United States (Recruiting)
- Neuro-Behavioral Clinical Research — North Canton, Ohio, United States (Recruiting)
- Community Clinical Research — Austin, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.