Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KYN-5356 as Adjunctive Treatment in Adults With Cognitive Impairment Associated With Schizophrenia
Led by Kynexis B.V. · Updated on 2025-09-25
150
Participants Needed
13
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of KYN-5356 on adults who have cognitive impairment associated with schizophrenia (CIAS). This Phase 2 study compares the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of three different doses of KYN-5356 with a placebo over 28 days. The goal is to understand how this drug impacts brain function and cognitive abilities in this population. Participants will be randomly assigned to one of four groups: low, medium, or high dose of KYN-5356, or placebo. They will take oral tablets daily for 28 days while staying in a clinic from three days before dosing starts until the day after dosing ends. Some participants at selected sites will undergo special electrophysiological tests to assess brain activity changes from the treatment. Throughout the study, participants will have regular assessments to monitor safety, treatment effects, and drug levels in the body. After completing the treatment period and safety checks, participants will leave the clinic on Day 29 and return for a follow-up visit on Day 42. The primary measure is the drug's impact on cognitive function after 28 days of treatment.
CONDITIONS
Brief Title
A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has an established primary psychiatric diagnosis of schizophrenia
- Clinically stable and in the residual (nonacute) phase of illness for at least 8 weeks before screening
- Diagnosis of schizophrenia for at least 1 year before screening
- On ongoing maintenance antipsychotic monotherapy on a stable regimen for 2 months or more before screening
- Male or female aged 18 to 55 years
- Body mass index (BMI) between 18 and 40 kg/m2 inclusive
- Able to comply with all protocol procedures
- Signed and dated informed consent prior to screening
You will not qualify if you...
- Currently treated with more than 1 antipsychotic at screening
- Score of 2 or higher on any item of the Modified Simpson-Angus Scale at screening
- Moderate to severe substance use disorder (excluding nicotine or caffeine, including alcohol)
- Evidence of unstable medical condition
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants receive KYN-5356 or placebo as an adjunctive treatment for cognitive impairment associated with schizophrenia.
Participants take oral tablets daily for 28 days
Trial Site Locations
Total: 13 locations
1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
2
Synergy Research Center
Lemon Grove, California, United States, 92064
Actively Recruiting
3
Cenexel CNS
Los Alamitos, California, United States, 90720
Actively Recruiting
4
Cenexel RCA
Hollywood, Florida, United States, 33024
Actively Recruiting
5
Segal Trials
Miami Lakes, Florida, United States, 33016
Actively Recruiting
6
Cenexel ACMR
Atlanta, Georgia, United States, 30331
Actively Recruiting
7
Cenexel iResearch Atlanta
Decatur, Georgia, United States, 30030
Actively Recruiting
8
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
9
Cenexel CBH
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
10
Arch Clinical Trials
St Louis, Missouri, United States, 63125
Actively Recruiting
11
Cenexel HRI
Marlton, New Jersey, United States, 08053
Actively Recruiting
12
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
13
Community Clinical Research
Austin, Texas, United States, 78754
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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