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New hope for brain fog in schizophrenia? drug trial targets memory and focus

NCT ID NCT07191483

Symptom relief Sponsor: Kynexis B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new medicine called KYN-5356 to see if it can help with thinking and memory problems in people with schizophrenia. About 150 adults who are stable on their current schizophrenia treatment will take either a low, medium, or high dose of the drug or a placebo for 28 days while staying at a clinic. Researchers will measure changes in cognitive function using a digital test and check safety and drug levels in the body.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment associated with schizophrenia (CIAS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arch Clinical Trials

    RECRUITING

    St Louis, Missouri, 63125, United States

  • Cenexel ACMR

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Cenexel CBH

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Cenexel CNS

    RECRUITING

    Los Alamitos, California, 90720, United States

  • Cenexel HRI

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Cenexel RCA

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Cenexel iResearch Atlanta

    RECRUITING

    Decatur, Georgia, 30030, United States

  • Community Clinical Research

    RECRUITING

    Austin, Texas, 78754, United States

  • Neuro-Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • NeuroBehavioral Hospitals of the Palm Beaches - South

    RECRUITING

    Boynton Beach, Florida, 33426, United States

  • Segal Trials

    TERMINATED

    Miami Lakes, Florida, 33016, United States

  • Synapse Clinical Trials

    RECRUITING

    Cerritos, California, 80703, United States

  • Synergy Research Center

    RECRUITING

    Lemon Grove, California, 92064, United States

  • Uptown Research Institute

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Woodland International Research Group

    RECRUITING

    Little Rock, Arkansas, 72211, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.