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Hope for Alzheimer's agitation: new drug combo enters final testing

NCT ID NCT07011745

Symptom relief Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Updated 6 times

Summary

This phase 3 trial tests whether a combination of two drugs, KarXT and KarX-EC, can safely reduce agitation in people with Alzheimer's disease. About 352 adults with Alzheimer's-related agitation will receive either the drug combo or a placebo for 14 weeks. The main goal is to see if agitation scores improve more with the active treatment.

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 Chloride (KarXT) and Xanomeline Enteric Capsule (KarX-EC)
What this could lead to
If it works, this could provide a new option to calm agitation in people with Alzheimer's, improving their quality of life and reducing caregiver burden.
What could go wrong
This is a phase 3 trial, but it's still experimental. The drug may not work better than a placebo, and side effects like gastrointestinal issues or dizziness 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 426 people

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

Started

Jul 2025

Expected to finish

Nov 2028

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 \- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following: * Amyloid PET. * Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay. * Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1). * Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) 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 agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1). * AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2). * Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and Visit 2. Exclusion Criteria \- Medical Conditions. i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia. ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR. \- Prior/Concomitant Therapy. i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam). A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted. B. Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1). Note: Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1). \- Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Psychomotor Agitation

As listed by the trial registrant

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

Alzheimer disease 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

    129 sites in 14 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

  • "Medical Centre "Neuroclinic" LLC

    RECRUITING

    Lviv, 79035, Ukraine

  • A-SHINE s.r.o.

    RECRUITING

    Pilsen, 301 00, Czechia

  • AGE Centrum

    RECRUITING

    Olomouc, Olomouc Region, 779 00, Czechia

  • ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Accellacare

    RECRUITING

    Long Beach, California, 90807, United States

  • Agile Clinical Research Trials, LLC

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Auxologico IRCCS - Auxologico San Luca

    RECRUITING

    Milan, Lombardy, 20149, Italy

  • Azienda Ospedaliera Spedali Civili di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, PI, 56126, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155

    RECRUITING

    Rome, Lazio, 00185, Italy

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    RECRUITING

    Rome, Lazio, 00189, Italy

  • Bayit Balev Ltd.

    RECRUITING

    Rishon Le'Tzion, 7590653, Israel

  • Biomedica Research Group

    RECRUITING

    Santiago, Santiago Metropolitan, 7500710, Chile

  • Black Country Healthcare NHS Foundation Trust

    RECRUITING

    Wolverhampton, WV4 5HN, United Kingdom

  • CMRC Headlands

    RECRUITING

    San Juan, 00918, Puerto Rico

  • CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)

    RECRUITING

    Kyiv, 04080, Ukraine

  • CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)"

    RECRUITING

    Hlevakha, 08631, Ukraine

  • COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

    RECRUITING

    Lviv, Lviv Oblast, 79021, Ukraine

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

    RECRUITING

    Lille, 59037, France

  • Centre Hospitalier Universitaire Toulouse - Cité de la Santé

    RECRUITING

    Toulouse, Haute-Garonne, 31000, France

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

    RECRUITING

    Limoges, 87042, France

  • Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location

    RECRUITING

    Paris, 75010, France

  • Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, 1058, Argentina

  • Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii

    RECRUITING

    Katowice, 40-146, Poland

  • Centrum Medyczne HCP Szpital im. Jana Pawla II

    RECRUITING

    Poznan, Greater Poland Voivodeship, 61-485, Poland

  • Centrum Medyczne NEUROMED

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

  • Chandler Clinical Trials, LLC

    RECRUITING

    Chandler, Arizona, 85224, United States

  • Clinica Alemana

    RECRUITING

    Vitacura, Santiago Metropolitan, 2511433, Chile

  • Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"

    RECRUITING

    Poltava, 36013, Ukraine

  • Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council

    RECRUITING

    Kropyvnytskyi, 25491, Ukraine

  • Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"

    RECRUITING

    Smila, Cherkasy Oblast, 20708, Ukraine

  • Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"

    RECRUITING

    Hlevakha, Kyiv Oblast, 08631, Ukraine

  • Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"

    RECRUITING

    Vinnytsia, Vinnytsia Oblast, 21037, Ukraine

  • Cornwall Partnership NHS Foundation Trust

    RECRUITING

    Redruth, TR15 3QE, United Kingdom

  • Debreceni Egyetem Klinikai Kozpont

    RECRUITING

    Debrecen, Hajdú-Bihar, 4031, Hungary

  • Envision Trials LLC

    RECRUITING

    Bonita Springs, Florida, 34134-4154, United States

  • Epic Medical Research, LLC - Carrolton

    RECRUITING

    Carrollton, Texas, 75006, United States

  • Epic Medical Research, LLC - Mesquite

    RECRUITING

    Mesquite, Texas, 75150, United States

  • EvergreenHealth Medical Center

    RECRUITING

    Kirkland, Washington, 98034, United States

  • Fondazione Policlinico Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM

    RECRUITING

    Buenos Aires, 1133, Argentina

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, 405-760, South Korea

  • Gangnam Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 06273, South Korea

  • Hattiesburg Clinic

    RECRUITING

    Hattiesburg, Mississippi, 39402, United States

  • Hopital Gui Chauliac - Chu Montpellier

    RECRUITING

    Montpellier, 34295, France

  • Horizon Clinical Research Center - Houston

    RECRUITING

    Cypress, Texas, 77429, United States

  • Hospital Italiano de Buenos Aires (HIBA)

    RECRUITING

    Buenos Aires, 1199, Argentina

  • Hôpital des Charpennes - Hospices Civils de Lyon (HCL)

    RECRUITING

    Villeurbanne, Rhône, 69100, France

  • IPTB Clinical Research

    RECRUITING

    Tampa, Florida, 33629, United States

  • Inha University Hospital

    RECRUITING

    Incheon, Incheon Gwang'yeogsi, 22332, South Korea

  • Institut neuropsychiatricke pece (INEP), Praha

    RECRUITING

    Prague, Praha 8, 18600, Czechia

  • Instituto De Neurologia Dra. Ivonne Fraga

    RECRUITING

    San Juan, 00918, Puerto Rico

  • Instituto Modelo de Neurología, Fundación Lennox

    RECRUITING

    Córdoba, 5000, Argentina

  • Instituto Médico DAMIC

    RECRUITING

    Córdoba, X5003DCE, Argentina

  • Key Clinical Research

    RECRUITING

    Bradenton, Florida, 34207, United States

  • Konkuk University Medical Center

    RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea

  • Kyungpook National University Chilgok Hospital

    RECRUITING

    Deagu, Taegu-Kwangyǒkshi, 41404, South Korea

  • Lancashire & South Cumbria NHS Foundation Trust

    RECRUITING

    Preston, Lancashire, PR2 9HT, United Kingdom

  • Las Vegas Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89030, United States

  • Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau

    RECRUITING

    Strasbourg, 67091, France

  • Limited Liability Company "Iqmed"

    RECRUITING

    Lviv, 79035, Ukraine

  • Local Institution - 2008

    NOT_YET_RECRUITING

    Río Cuarto, Córdoba Province, 5800, Argentina

  • Local Institution - 2050

    NOT_YET_RECRUITING

    Santiago, Santiago Metropolitan, 7560356, Chile

  • Local Institution - 2055

    NOT_YET_RECRUITING

    Viña del Mar, Valparaiso, 2511433, Chile

  • Local Institution - 2102

    WITHDRAWN

    Prague, 100 000, Czechia

  • Local Institution - 2105

    WITHDRAWN

    Prague, 100 00, Czechia

  • Local Institution - 2201

    NOT_YET_RECRUITING

    Düsseldorf, 40221, Germany

  • Local Institution - 2205

    NOT_YET_RECRUITING

    Halle, 06120, Germany

  • Local Institution - 2206

    NOT_YET_RECRUITING

    Westerstede, 26655, Germany

  • Local Institution - 2250

    WITHDRAWN

    Győr, Győr-Moson-Sopron, 0, Hungary

  • Local Institution - 2251

    WITHDRAWN

    Budapest, 1083, Hungary

  • Local Institution - 2254

    NOT_YET_RECRUITING

    Gyöngyös, Heves County, 3200, Hungary

  • Local Institution - 2255

    NOT_YET_RECRUITING

    Budapest, 1036, Hungary

  • Local Institution - 2256

    NOT_YET_RECRUITING

    Budapest, 1033, Hungary

  • Local Institution - 2257

    NOT_YET_RECRUITING

    Kalocsa, Bács-Kiskun county, 6300, Hungary

  • Local Institution - 2302

    NOT_YET_RECRUITING

    Petch Tikva, IL, 49100, Israel

  • Local Institution - 2355

    WITHDRAWN

    Isernia, 86077, Italy

  • Local Institution - 2406

    WITHDRAWN

    Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

  • Local Institution - 2451

    WITHDRAWN

    Lublin, 20-064, Poland

  • Local Institution - 2452

    WITHDRAWN

    Lublin, 20-064, Poland

  • Local Institution - 2457

    NOT_YET_RECRUITING

    Wroclaw, 53-659, Poland

  • Local Institution - 2458

    NOT_YET_RECRUITING

    Krakow, 31-505, Poland

  • Local Institution - 2500

    NOT_YET_RECRUITING

    London, W12 0NN, United Kingdom

  • Local Institution - 2502

    NOT_YET_RECRUITING

    Cambridge, CB21 5EF, United Kingdom

  • Local Institution - 2509

    WITHDRAWN

    Stafford, ST16 3SR, United Kingdom

  • Local Institution - 2560

    NOT_YET_RECRUITING

    Lutsk, Volyn Oblast, 43005, Ukraine

  • Local Institution - 2562

    NOT_YET_RECRUITING

    Ternopil, 46027, Ukraine

  • Local Institution - 2565

    NOT_YET_RECRUITING

    Kyiv, 01030, Ukraine

  • Local Institution - 2601

    WITHDRAWN

    Basalt, Colorado, 81621, United States

  • Local Institution - 2603

    COMPLETED

    Ozark, Missouri, 65721, United States

  • Local Institution - 2606

    NOT_YET_RECRUITING

    Homestead, Florida, 33032, United States

  • Local Institution - 2607

    NOT_YET_RECRUITING

    Long Beach, California, 90805, United States

  • Local Institution - 2610

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Local Institution - 2612

    COMPLETED

    Bountiful, Utah, 84010, United States

  • Local Institution - 2613

    NOT_YET_RECRUITING

    Pasadena, California, 91105, United States

  • Local Institution - 2614

    NOT_YET_RECRUITING

    San Diego, California, 92108, United States

  • Local Institution - 2615

    COMPLETED

    Worcester, Massachusetts, 01608, United States

  • Local Institution - 2618

    COMPLETED

    Ann Arbor, Michigan, 48105, United States

  • Local Institution - 2620

    COMPLETED

    West Hills, California, 91307, United States

  • Local Institution - 2627

    NOT_YET_RECRUITING

    Napa, California, 94558, United States

  • Local Institution - 2630

    NOT_YET_RECRUITING

    Saint Paul, Minnesota, 55130, United States

  • Local Institution - 2631

    NOT_YET_RECRUITING

    Chandler, Arizona, 85226-3732, United States

  • Local Institution - 2632

    NOT_YET_RECRUITING

    Norwalk, Connecticut, 06851, United States

  • Local Institution - 2634

    NOT_YET_RECRUITING

    Orlando, Florida, 32806, United States

  • Local Institution - 2636

    NOT_YET_RECRUITING

    Doral, Florida, 33122, United States

  • Local Institution - 2637

    NOT_YET_RECRUITING

    Miami, Florida, 33165, United States

  • Local Institution - 2639

    NOT_YET_RECRUITING

    San Juan, 00918, Puerto Rico

  • Local Institution - 2647

    NOT_YET_RECRUITING

    Brooklyn, New York, 11229, United States

  • Local Institution - 2648

    NOT_YET_RECRUITING

    Aventura, Florida, 33180, United States

  • Local Institution - 2650

    NOT_YET_RECRUITING

    Toms River, New Jersey, 08755, United States

  • M2M Med

    RECRUITING

    Chorzów, 41-500, Poland

  • MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC

    RECRUITING

    Dnipro, Dnipropetrovsk Oblast, 49115, Ukraine

  • Miami Jewish health

    RECRUITING

    Miami, Florida, 33137, United States

  • Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council

    RECRUITING

    Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine

  • Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council

    RECRUITING

    Oleksandrivka, Odesa Oblast, 67513, Ukraine

  • NEUROHK

    RECRUITING

    Choceň, 565 01, Czechia

  • National Institute of Clinical Research

    RECRUITING

    Garden Grove, California, 92844, United States

  • Neuro Health Centrum s.r.o.

    RECRUITING

    Brno, South Moravian, 628 00, Czechia

  • NeuroClin Glasgow

    RECRUITING

    Motherwell, ML1 4UF, United Kingdom

  • Neuropsychiatrie

    RECRUITING

    Prague, Praha 6, 160 00, Czechia

  • Pontificia Universidad Catolica de Chile

    RECRUITING

    Santiago, Santiago Metropolitan, 8330024, Chile

  • Psicomed Estudios Médicos Cía Ltda

    RECRUITING

    Antofagasta, 1270244, Chile

  • RCMed Oddzial Sochaczew

    RECRUITING

    Sochaczew, 96-500, Poland

  • Resolution Psychopharmacology Research Institute

    RECRUITING

    Mendoza, 5502, Argentina

  • Richmond Behavioral Associates

    RECRUITING

    Staten Island, New York, 10312, United States

  • SMG-SNU Borame Medical Center

    RECRUITING

    Seoul, 07061, South Korea

  • Sanatorio Morra S.A.

    RECRUITING

    Córdoba, 5000, Argentina

  • Sanz MC, Laniado Hospital

    RECRUITING

    Netanya, 4244916, Israel

  • Semmelweis Egyetem

    RECRUITING

    Budapest, 1083, Hungary

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

  • Sheffield Health and Social care NHS Foundation Trust

    RECRUITING

    Sheffield, S5 7JT, United Kingdom

  • South London and Maudsley NHS Foundation Trust

    RECRUITING

    London, SE5 8AZ, United Kingdom

  • Surrey and Borders Partnership NHS Foundation Trust

    RECRUITING

    Chertsey, Surrey, KT16 9AU, United Kingdom

  • The Catholic University of Korea, Yeouido St.Mary's Hospital

    RECRUITING

    Seoul, 07345, South Korea

  • The Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5262000, Israel

  • The Israeli Alzheimer Medical Center

    RECRUITING

    Ramat Gan, 5265601, Israel

  • TrialSphere Corp

    RECRUITING

    Chandler, Arizona, 85286, United States

  • UT Health - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Naples Federico II

    RECRUITING

    Naples, Campania, 80131, Italy

  • Velocity Clinical Research - Blue Ash

    RECRUITING

    Blue Ash, Ohio, 45242, United States

  • Vestra Clinics s.r.o.

    RECRUITING

    Rychnov nad Kněžnou, 516 01, Czechia

  • Walnut Clinical Research

    RECRUITING

    Valley Stream, New York, 11580, United States

  • West Clinical Research

    RECRUITING

    Morehead City, North Carolina, 28557, United States

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