A Study to Evaluate KYN-5356 in Adults With Cognitive Impairment Associated With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: KYN-5356 low dose, Placebo, KYN-5356 Medium Dose, KYN-5356 High Dose.
- Who it may be relevant to
- Registry conditions: Cognitive Impairment Associated With Schizophrenia (CIAS). Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
This is a Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, Pharmacokinetic (PK) and Pharmacodynamic (PD) effects of 3 different dose regiments of KYN-5356 and placebo for 28 days. Participants will be randomized to one of 4 treatment groups: placebo, KYN-5356 low dose, KYN-5356 medium dose, KYN-5356 high dose. Participants will be admitted to the clinic on Day -3 and will remain in residence at the clinic for 32 days, from baseline through the treatment period. Participants will be administered investigational medicinal product on Days 1 through 28. Efficacy, safety, PK and exploratory PD assessments will be performed throughout the dosing period. Participants will be discharged on Day 29 after safety assessments are completed and return for a follow-up visit on Day 42. A subset of participants from selected sites will undergo electrophysiological assessments to evaluate the effect of KYN-5356 on neurophysiological measures of brain function.
Interventions
- Drug KYN-5356 low dose
oral tablet - Other Placebo
Oral tablet - Drug KYN-5356 Medium Dose
oral tablet - Drug KYN-5356 High Dose
oral tablet
Primary outcome measures
- To evaluate the efficacy of KYN-5356 treatment on cognitive function in adults with cognitive impairment associated with schizophrenia (CIAS) [Time frame: 28 days]
Secondary outcome measures (5)
- Cmax [Time frame: 28 days]
- AUCtau [Time frame: 28 Days]
- Tmax [Time frame: 28 Days]
- Ctrough [Time frame: 28 Days]
- Terminal half-life (t1/2) [Time frame: 28 Days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 15 centers
- Woodland International Research Group — Little Rock
- Synapse Clinical Trials — Cerritos
- Synergy Research Center — Lemon Grove
- Cenexel CNS — Los Alamitos
- NeuroBehavioral Hospitals of the Palm Beaches - South — Boynton Beach
- Cenexel RCA — Hollywood
- Segal Trials — Miami Lakes
- Cenexel ACMR — Atlanta
- … and 7 more centers
Identifiers
NCT: NCT07191483 · KYN5356-CL-002