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Hope for Alzheimer's psychosis: new drug aims to stop relapses

NCT ID NCT05511363

Disease control Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 4 times

Summary

This study tests an investigational drug called KarXT to see if it can prevent the return of psychosis (like hallucinations or delusions) in people with Alzheimer's disease. About 410 participants aged 55-90 will receive either KarXT or a placebo for 38 weeks. The main goal is to see if KarXT delays or prevents a relapse compared to placebo.

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 410 people

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

Started

Aug 2022

Expected to finish

Oct 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

55 to 90 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: * Is aged 55 to 90 years, inclusive, at Screening * Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met. i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide assent or similar where permitted per local law/regulation and as approved by the IRB/IEC. * Meets clinical criteria for possible or probable Alzheimer's Disease * Has a Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening. * Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study. * Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥ approximately 7 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to: i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures; iii) Participate in the study assessments and provide informed consent to participate in the study. * History of psychotic symptoms (meeting International Psychogeriatric Association \[IPA\] criteria) for at least 2 months prior to Screening. * Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions. * Subjects are required to meet at least one of the following criteria at Screening and Baseline: i) Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR; ii) Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items. * Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening * If the subject is taking a cholinesterase inhibitor and/or memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study. * Participant is willing and able to attend the study visit for the study duration, follow instructions, and comply with the protocol requirements * BMI must be within 16 to 40 kg/m2 and participants with a BMI of 16 to \<18 kg/m2 must have a body weight ≥40 kg. * A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding. Individual of childbearing potential (IOCBP) must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP. Exclusion Criteria: * Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia * History of major depressive episode with psychotic features during the 12 months prior to Screening * History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder * Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results * Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<50 mL/min * History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke * History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope * Any of the following: i) New York Heart Association Class 2 congestive heart failure; ii) Grade 2 or greater angina pectoris; iii) Sustained ventricular tachycardia; iv) Ventricular fibrillation; v) Torsade de pointes; vi) Implantable cardiac defibrillator. * Myocardial infarction within the 6 months prior to Screening * Personal or family history of symptoms of long QT syndrome as evaluated by the investigator * Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results * History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator * Participants with any of the following: i) History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants: 1. Serum prostate specific antigen (PSA) \> 10 ng/mL at Screening 2. An IPSS of 5 (almost always) on items 1, 3, 5, or 6 3. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 * History of obstructive gastrointestinal disorder, gastric retention, irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months * Risk of suicidal behavior during the study as determined by clinical assessment and/ or C-SSRS * Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening * Urine toxicology screen is positive substances other than cannabis or benzodiazepines (both cannabis and short-or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor * Currently receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), mood stabilizers (eg, lithium) tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam) and unable to complete the washout: i) Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening may be permitted; ii) Mirtazapine or trazodone may be used if started at least 8 weeks prior to Screening. If needed, an extension (up to two weeks) of the Screening Period may be allowed with approval of the Sponsor/Medical Monitor. * If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/ Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements * Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator * Unable to taper and discontinue a concomitant medication that would preclude participation in the study * Prior exposure to KarXT * Experienced any significant adverse events due to trospium, including a known hypersensitivity to trospium * Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the past year * Other protocol-defined Inclusion/Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

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

Psychosis associated with Alzheimer's disease

How to take part

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

  1. The places running it

    49 sites in 11 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

  • A-SHINE s.r.o.

    RECRUITING

    Pilsen, 301 00, Czechia

  • ATP Clinical Research-302 W La Veta Ave

    RECRUITING

    Orange, California, 92866, United States

  • Arrow Clinical Trials

    RECRUITING

    Daytona Beach, Florida, 32117-5532, United States

  • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

    RECRUITING

    Baggiovara, Modena, 41126, Italy

  • CHU de Reims Hôpital Robert Debré

    RECRUITING

    Reims, Marne, 51100, France

  • CLINTRIAL s.r.o.

    RECRUITING

    Prague, Praha, Hlavní Mesto, 100 00, Czechia

  • Clinical Centre of Vojvodina

    RECRUITING

    Novi Sad, 21000, Serbia

  • Clinical Hospital Center Dragisa Misovic Dedinje

    RECRUITING

    Belgrade, 11000, Serbia

  • Clinical Trial Network - 7080 Southwest Fwy

    RECRUITING

    Houston, Texas, 77074-2085, United States

  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    RECRUITING

    Salamanca, 37007, Spain

  • Crystal Comfort, s.r.o.

    RECRUITING

    Vranov nad Topľou, 093 01, Slovakia

  • EPAMED s.r.o

    RECRUITING

    Košice, 040 01, Slovakia

  • Five Towns Neurology, PC

    RECRUITING

    Woodmere, New York, 11598-1739, United States

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    RECRUITING

    Roma, 00168, Italy

  • Hospital Provincial de Zamora

    RECRUITING

    Zamora, 49021, Spain

  • Hospital Universitario Rio Hortega

    RECRUITING

    Valladolid, 47012, Spain

  • Hospital Viamed Montecanal

    RECRUITING

    Zaragoza, 50012, Spain

  • Hospital Victoria Eugenia

    RECRUITING

    Seville, 41009, Spain

  • K2 Medical Research - Maitland

    RECRUITING

    Maitland, Florida, 32751-5669, United States

  • K2 Medical Research - Winter Garden

    RECRUITING

    Clermont, Florida, 34711-5933, United States

  • KONZILIUM s.r.o

    RECRUITING

    Dubnica nad Váhom, 018 41, Slovakia

  • Local Institution - 1-14IBHZ4D

    NOT_YET_RECRUITING

    Stara Zagora, 6003, Bulgaria

  • Local Institution - 1-14IG4A1R

    NOT_YET_RECRUITING

    Seoul, Seoul Teugbyeolsi, 05505, South Korea

  • Local Institution - 1-14IG4A3I

    NOT_YET_RECRUITING

    Pusan, Busan Gwangyeogsi, 49241, South Korea

  • Local Institution - 1-14IL3BFV

    NOT_YET_RECRUITING

    Prague, 109 00, Czechia

  • Local Institution - 1-14IL3BJP

    NOT_YET_RECRUITING

    New York, New York, 10003-1759, United States

  • Local Institution - 1-14IL3BK3

    NOT_YET_RECRUITING

    Ahmedabad, Gujarat, 380061, India

  • Local Institution - 1-14ILFYZQ

    NOT_YET_RECRUITING

    Salerno, Campania, 84131, Italy

  • Local Institution - 1-14ILFZ33

    NOT_YET_RECRUITING

    Villeurbanne, Rhône, 69100, France

  • Local Institution - 1-14IVVWPL

    NOT_YET_RECRUITING

    Junggu, Incheon Gwang'yeogsi, 22332, South Korea

  • Local Institution - 1-14IW4MT8

    NOT_YET_RECRUITING

    Hyderabad, 500034, India

  • Local Institution - 1-14IW4MUN

    NOT_YET_RECRUITING

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Local Institution - 1-14JRHMIY

    NOT_YET_RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Local Institution - 1002

    ACTIVE_NOT_RECRUITING

    Staten Island, New York, 10314-1607, United States

  • Local Institution - 1003

    WITHDRAWN

    Canton, Ohio, 44718, United States

  • Local Institution - 1005

    COMPLETED

    Miami, Florida, 33125-3724, United States

  • Local Institution - 1006

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33173-1474, United States

  • Local Institution - 1008

    ACTIVE_NOT_RECRUITING

    St. Petersburg, Florida, 33713-8844, United States

  • Local Institution - 1009

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33155-4630, United States

  • Local Institution - 1010

    COMPLETED

    Miami, Florida, 33137, United States

  • Local Institution - 1011

    COMPLETED

    Boca Raton, Florida, 33487-2768, United States

  • Local Institution - 1012

    COMPLETED

    Pensacola, Florida, 32504-8608, United States

  • Local Institution - 1013

    COMPLETED

    Stamford, Connecticut, 06905-1206, United States

  • Local Institution - 1014

    COMPLETED

    Colorado Springs, Colorado, 80907-5302, United States

  • Local Institution - 1015

    COMPLETED

    Bradenton, Florida, 34209-4687, United States

  • Local Institution - 1016

    COMPLETED

    Oklahoma City, Oklahoma, 73112, United States

  • Local Institution - 1017

    COMPLETED

    New York, New York, 10032, United States

  • Local Institution - 1018

    ACTIVE_NOT_RECRUITING

    Manhasset, New York, 11030-3816, United States

  • Local Institution - 1019

    COMPLETED

    Allentown, Pennsylvania, 18103, United States

  • Local Institution - 1020

    COMPLETED

    Bonita Springs, Florida, 34134, United States

  • Local Institution - 1021

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33122-1335, United States

  • Local Institution - 1022

    COMPLETED

    Flower Mound, Texas, 75028-2011, United States

  • Local Institution - 1024

    WITHDRAWN

    Hialeah, Florida, 33012-5884, United States

  • Local Institution - 1026

    ACTIVE_NOT_RECRUITING

    Miami Springs, Florida, 33166-5260, United States

  • Local Institution - 1027

    WITHDRAWN

    Ocala, Florida, 34470-6657, United States

  • Local Institution - 1028

    WITHDRAWN

    Oklahoma City, Oklahoma, 73104-5007, United States

  • Local Institution - 1029

    ACTIVE_NOT_RECRUITING

    Homewood, Alabama, 35209-6809, United States

  • Local Institution - 1030

    WITHDRAWN

    New York, New York, 10016, United States

  • Local Institution - 1031

    WITHDRAWN

    Irvine, California, 92612-1246, United States

  • Local Institution - 1032

    ACTIVE_NOT_RECRUITING

    Miami Lakes, Florida, 33014-5602, United States

  • Local Institution - 1033

    COMPLETED

    Encino, California, 91436-2201, United States

  • Local Institution - 1034

    COMPLETED

    Stony Brook, New York, 11794-0001, United States

  • Local Institution - 1035

    COMPLETED

    Charleston, South Carolina, 29425-8900, United States

  • Local Institution - 1036

    COMPLETED

    Frisco, Texas, 75034-6262, United States

  • Local Institution - 1037

    COMPLETED

    Chicago, Illinois, 60623, United States

  • Local Institution - 1038

    COMPLETED

    Franklin, Tennessee, 37067-5922, United States

  • Local Institution - 1040

    WITHDRAWN

    The Villages, Florida, 32159-8986, United States

  • Local Institution - 1041

    COMPLETED

    Tampa, Florida, 33607-4629, United States

  • Local Institution - 1042

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33186-5882, United States

  • Local Institution - 1043

    COMPLETED

    Pasadena, California, 91106, United States

  • Local Institution - 1044

    COMPLETED

    Phoenix, Arizona, 85012-2836, United States

  • Local Institution - 1045

    ACTIVE_NOT_RECRUITING

    Doral, Florida, 33172-2638, United States

  • Local Institution - 1046

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33012-5826, United States

  • Local Institution - 1047

    COMPLETED

    San Marcos, California, 92069-3595, United States

  • Local Institution - 1049

    ACTIVE_NOT_RECRUITING

    Homestead, Florida, 33032, United States

  • Local Institution - 1051

    COMPLETED

    New York, New York, 10032-3720, United States

  • Local Institution - 1052

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33012, United States

  • Local Institution - 1053

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33166, United States

  • Local Institution - 1054

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33186-4643, United States

  • Local Institution - 1111

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33173, United States

  • Local Institution - 1115

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33135, United States

  • Local Institution - 1129

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33165-3947, United States

  • Local Institution - 1143

    COMPLETED

    Miami, Florida, 33145-2455, United States

  • Local Institution - 2103

    WITHDRAWN

    Swindon, Wiltshire, SN3 6BW, United Kingdom

  • Local Institution - 2104

    WITHDRAWN

    Motherwell, ML1 4UF, United Kingdom

  • Local Institution - 2105

    WITHDRAWN

    Aberdeen, AB25 2ZL, United Kingdom

  • Local Institution - 2205

    COMPLETED

    Barcelona, 8028, Spain

  • Local Institution - 2207

    COMPLETED

    Madrid, 28006, Spain

  • Local Institution - 2301

    COMPLETED

    Rome, Lazio, 00179, Italy

  • Local Institution - 2302

    COMPLETED

    Pisa, 56126, Italy

  • Local Institution - 2304

    COMPLETED

    Milan, 20121, Italy

  • Local Institution - 2305

    COMPLETED

    Monza, 20900, Italy

  • Local Institution - 2307

    ACTIVE_NOT_RECRUITING

    Ponderano (Biella), Piedmont, 13875, Italy

  • Local Institution - 2308

    COMPLETED

    Florence, Tuscany, 50139, Italy

  • Local Institution - 2309

    COMPLETED

    Roma, 00189, Italy

  • Local Institution - 2401

    COMPLETED

    Böblingen, Baden-Wurttemberg, 71034, Germany

  • Local Institution - 2402

    WITHDRAWN

    Homburg, Saarland, 66424, Germany

  • Local Institution - 2403

    WITHDRAWN

    Bayreuth, Bavaria, 95445, Germany

  • Local Institution - 2502

    ACTIVE_NOT_RECRUITING

    Dijon, 21079, France

  • Local Institution - 2503

    COMPLETED

    Rouen, 76000, France

  • Local Institution - 4001

    COMPLETED

    Kutná Hora, 284 01, Czechia

  • Local Institution - 4003

    WITHDRAWN

    Brno, South Moravian, 628 00, Czechia

  • Local Institution - 4004

    COMPLETED

    Prague, 140 00, Czechia

  • Local Institution - 4101

    ACTIVE_NOT_RECRUITING

    Zagreb, City of Zagreb, 10090, Croatia

  • Local Institution - 4103

    COMPLETED

    Zagreb, City of Zagreb, 10000, Croatia

  • Local Institution - 4105

    ACTIVE_NOT_RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Local Institution - 4305

    COMPLETED

    Kovin, 26220, Serbia

  • Local Institution - 4307

    COMPLETED

    Belgrade, 11000, Serbia

  • Local Institution - 4311

    COMPLETED

    Vršac, 26300, Serbia

  • Local Institution - 4404

    WITHDRAWN

    Žilina, 012 07, Slovakia

  • Local Institution - 4502

    COMPLETED

    Sofia, Sofia-Grad, 1510, Bulgaria

  • Local Institution - 4504

    COMPLETED

    Vratsa, 3000, Bulgaria

  • Local Institution - 4505

    COMPLETED

    Sofia, Sofia-Grad, 1431, Bulgaria

  • Local Institution - 4506

    NOT_YET_RECRUITING

    Cherven Bryag, 5980, Bulgaria

  • MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.

    RECRUITING

    Banská Bystrica, 974 04, Slovakia

  • Medical Center Medconsult Pleven OOD

    RECRUITING

    Pleven, 5800, Bulgaria

  • Medical Center Sveti Naum EOOD

    RECRUITING

    Sofia, 1113, Bulgaria

  • Military Medical Academy

    RECRUITING

    Belgrade, 11000, Serbia

  • Military Medical Academy

    RECRUITING

    Belgrade, 11000, Serbia

  • Polyclinic Neuron

    RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Psychiatric Clinic Sveti Ivan

    RECRUITING

    Zagreb, City of Zagreb, 10090, Croatia

  • Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS

    RECRUITING

    Walnut Creek, California, 94596, United States

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center Kragujevac

    RECRUITING

    Kragujevac, 34000, Serbia

  • University Clinical Center of Serbia - Pasterova 2 - PPDS

    RECRUITING

    Belgrade, Belgrade, 11000, Serbia

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43

    RECRUITING

    Košice, Košice Region, 041 90, Slovakia

  • Vestra Clinics s.r.o.

    RECRUITING

    Rychnov nad Kněžnou, 516 01, Czechia

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