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Could a new drug sharpen the minds of people with schizophrenia?

NCT ID NCT07084831

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new medicine, Xanomeline/Trospium (also called KarXT), can improve thinking and memory in adults with schizophrenia. Unlike standard antipsychotics, this drug targets a different brain system and may help with cognitive symptoms. Researchers will follow 171 participants for up to a year, measuring changes in cognition, symptoms, and daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Xanomeline/Trospium (also known as KarXT/Cobenfy)
What this could lead to
If it works, this could show that Xanomeline/Trospium improves thinking and memory in people with schizophrenia, potentially leading to better daily functioning and quality of life.
What could go wrong
This is an early-phase, open-label study with no placebo group, so results may be less reliable. Cognitive improvements are not guaranteed, and side effects are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 171 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: 1. Be between 18 and 55 years of age. 2. Be willing and able to provide informed consent, after the nature of the study has been fully explained. This includes being able to understand the locally approved informed consent (and information letter) in the local language. 3. Have a current DSM-5 diagnosis of schizophrenia, which needs to be confirmed by MINI. 4. Have all PANSS positive items + G8 and G10 ≤4 at screening. 5. Be on a stable dose of oral antipsychotic medication(s) for at least 4 weeks prior to Screening. Participants should be on monotherapy oral AP for baseline visit. 6. Have a SCIP total below 70. 7. Test negative for pregnancy at the screening visit and must be using a highly effective contraceptive method during the study and 30 days after the study, if being a female of childbearing potential. Exclusion criteria: 1. Be pregnant, lactating, or less than 3 months postpartum. 2. Be at significant risk of committing suicide. This is defined as: participants with active suicidal ideation with some intent to act, without specific plan ("Yes" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS) or active suicidal ideation with specific plan and intent ("Yes" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the participant to participate in the study. 3. Currently meet DSM-5 criteria for a manic episode or major depressive disorder as confirmed by the MINI. 4. Currently meeting DSM-5 criteria for severe substance and/or alcohol use disorder as confirmed by the MINI (≥6 on module K for alcohol use disorder and/or ≥6 on module J for substance use disorder, unless being in early or sustained remission). 5. Have a positive urine toxicology for phencyclidine, amphetamines, opiates (unless participant has a valid prescription for short-term use), cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator). Nicotine and caffeine use is allowed. Stimulants and cannabis is allowed when used sporadically and recreationally as per the judgement of the clinician. 6. Present with an intellectual disability, drug-induced psychosis, or history of clinically significant brain trauma as per the judgement of the clinician. 7. Have current or past use of clozapine (used for at least 6 weeks in an effective dose range) and/or current use of a long-acting injectable antipsychotic, or anticholinergic treatment that cannot be discontinued before the baseline visit. 8. Be expected to require more than the allowed psychotropic concomitant medication during the study (from baseline on). This is defined as: needing benzodiazepines of more than 2 mg lorazepam equivalent (daily), quetiapine, antidepressants, mood stabilizers or benzodiazepines at a dose exceeding the allowed threshold. If these treatments are used at the screening visit, they must be tapered down before the baseline visit. 9. Have clinically significant abnormal finding on the physical examination, medical history, ECG (at screening), or clinically significant laboratory results at screening. 10. Participated in any cognitive remediation/training program or completed the BACS within 4 weeks of Screening. 11. Having a known allergy to xanomeline, trospium chloride or any of the ingredients of XT. 12. Have current presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (e.g., obstructive disorders \[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\], endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. This includes: 12a. Have history or high risk of urinary retention. 12b. All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]). 12c. Elevations in hepatic transaminases at screening ≥ 2× ULN for ALT and AST and/or bilirubin \> 2 × ULN, unless in the context of Gilbert's syndrome. 12d. Have a history or high risk for narrow-angle glaucoma. 12e. Active biliary disease (e.g., symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the sponsor. 12f. Participants with a history of bladder stones . 12g. Participants with a history of recurrent urinary tract infections. 12h. For all male participants, serum prostate-specific antigen \>10 ng/mL at screening. 12i. For male participants ≥ 45 years of age, an IPSS score of 5 (i.e, "almost always") on items 1, 3, 5, or 6, and/or for male participants ≥ 45 years of age, an IPSS score ≥ 9 for the sum of items 1, 3, 5, and 6. 12j. An eGFR of \< 60 mL/min (which indicates renal dysfunction). 12k. History of unstable hypertension or tachycardia as evidenced by a blood pressure of ≥ 160/100 mmHg at screening and/or a heart rate of ≥ 110 bpm at screening.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction Psychotic Disorders schizophrenia

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    16 sites in 10 countries. 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

  • AOU Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Central Institute of Mental Health

    Mannheim, 68159, Germany

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen del Rocío

    Seville, 41013, Spain

  • Ludwig Maximilian University

    München, 80336, Germany

  • Medical University Innsbruck

    Innsbruck, 6020, Austria

  • National Institute of Mental Health

    Klecany, 250 67, Czechia

  • Psykiatrisk Center Glostrup

    Glostrup Municipality, 2600, Denmark

  • Semmelweis University

    Budapest, 1083, Hungary

  • Sheba Medical Center

    Ramat Gan, Israel

  • UPC KU Leuven

    Leuven, 3070, Belgium

  • University Hospital Cologne

    Cologne, 50937, Germany

  • University Medical Center Groningen

    Groningen, Netherlands

  • University of Augsburg

    Augsburg, 86156, Germany

  • University of Campania Luigi Vanvitelli

    Naples, 80138, Italy

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