Could a drug combo ease Alzheimer's agitation? large trial underway

NCT ID NCT07011732

Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 12, 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 will receive either the drug combo or a placebo for 14 weeks. The main goal is to see if agitation symptoms improve, as measured by a standard rating scale.

What this could mean

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

Active substance: KarXT (xanomeline/trospium) plus KarX-EC (xanomeline enteric capsule)
What this could lead to: If it works, this could provide a new option to calm agitation in Alzheimer's patients, improving quality of life for them and their caregivers.
What could go wrong: This is still an experimental treatment. Even if effective, it only targets agitation, not the underlying Alzheimer's disease, 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 426 people

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

Started

Jul 2025

Expected to finish

Dec 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). * CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (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). C. 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

As listed by the trial registrant

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

Alzheimer disease

How to take part

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

The places running it

147 sites in 15 countries. The list below names each one and where it is.
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 ↗
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

AVIX Investigacion Clinica
RECRUITING

Monterrey, Nuevo León, 64623, Mexico
Advanced Neurology Epilepsy and Sleep Center
RECRUITING

El Paso, Texas, 79912, United States
Advanced Research Center (ARC) - Anaheim
RECRUITING

Anaheim, California, 92805, United States
Aiginiteio University Hospital
RECRUITING

Athens, Attikí, 115 28, Greece
Asakayama Hospital
RECRUITING

Sakai, Osaka, 590-0018, Japan
Athens Medical Center
RECRUITING

Athens, 15125, Greece
Beijing Anding Hospital Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100088, China
Boca Clinical Trials Mexico S.C.
RECRUITING

Guadalajara, Jalisco, 44600, Mexico
Boston Center for Memory
RECRUITING

Newton, Massachusetts, 02459, United States
CBH Health
RECRUITING

Gaithersburg, Maryland, 20877, United States
CECPAR - Centro de Estudos Clínicos do Paraná
RECRUITING

Curitiba, Paraná, 80030-310, Brazil
CEN Centro Especializado en Neurociencias
RECRUITING

Córdoba, Córdoba Province, 5004, Argentina
CPQuali Pesquisa Clínica
RECRUITING

São Paulo, 01228-000, Brazil
Cai Ferate Clinical Hospital Constanta
RECRUITING

Constanța, 90123, Romania
Campus Neurologico Senior
RECRUITING

Torres Vedras, 2560-280, Portugal
Central States Research
RECRUITING

Tulsa, Oklahoma, 74136, United States
Centre for Addiction & Mental Health
RECRUITING

Toronto, Ontario, M6J 1H4, Canada
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
RECRUITING

Lisbon, 1649-035, Portugal
Centro Hospitalar do Alto Ave
RECRUITING

Guimarães, 4835-044, Portugal
Centro Medico Luquez
RECRUITING

Córdoba, 5006, Argentina
Chang Gung Medical Foundation-Linkou Branch
RECRUITING

Taoyuan, 333, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Clinica Universidad de Navarra
RECRUITING

Pamplona, 31008, Spain
Clinica Viver - Centro de Desospitalizacao Humana
RECRUITING

São Paulo, 04020-060, Brazil
Clinical Hospital Center Split
RECRUITING

Split, HR-21000, Croatia
Clinical Psychiatric Hospital "Dr. Gheorghe Preda"
RECRUITING

Sibiu, 550082, Romania
Clinical Research Institute S.C.
RECRUITING

Tlalnepantla, 54055, Mexico
Combined Research Orlando (CRO)
RECRUITING

Orlando, Florida, 32807, United States
Complejo Hospitalario Ruber Juan Bravo
RECRUITING

Madrid, 28006, Spain
Eginition Hospital
RECRUITING

Athens, 11528, Greece
Elixia MA
RECRUITING

Springfield, Massachusetts, 01103, United States
Euromedica General Clinic of Thessaloniki
RECRUITING

Thessaloniki, 54645, Greece
Five Towns Neurology PC -Woodmere - 923 Broadway
RECRUITING

Woodmere, New York, 11598-1739, United States
Fundacion Estudios Clinicos
RECRUITING

Rosario, Santa Fe Province, S2000DEJ, Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
RECRUITING

Buenos Aires, C1428AQK, Argentina
General Hospital Varazdin
RECRUITING

Varaždin, 42000, Croatia
Global Medical Institutes LLC; Princeton Medical Institute
RECRUITING

Princeton, New Jersey, 08540, United States
Hatano Kousei Hospital
RECRUITING

Hadano, Kanagawa, 257-0003, Japan
Henry Dunant Hospital Center
RECRUITING

Athens, Attica, 115 26, Greece
Hope Research Network - Miami
RECRUITING

Miami, Florida, 33166, United States
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Clinico Universitario Virgen de La Victoria
RECRUITING

Málaga, 29010, Spain
Hospital General Universitario de Elche
RECRUITING

Elche (alicante), 03203, Spain
Hospital Moinhos de Vento
RECRUITING

Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Hospital Mutua Terrassa
RECRUITING

Terrassa, 8221, Spain
Hospital Universitario De Rio Hortega
RECRUITING

Valladolid, 47012, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITING

Salamanca, 37007, Spain
Hospital Universitario de Saltillo
RECRUITING

Saltillo, Coahuila, 25000, Mexico
Hospital Viamed Montecanal
RECRUITING

Zaragoza, 50012, Spain
Hospital Victoria Eugenia de Sevilla
RECRUITING

Seville, 41009, Spain
Imaging Endpoints
RECRUITING

Scottsdale, Arizona, 85258, United States
Innovacion y Desarrollo en Ciencias de la Salud
RECRUITING

Mexico City, Mexico City, 14090, Mexico
Instituto Privado Kremer
RECRUITING

Córdoba, 5004, Argentina
Instituto de Pesquisa Clínica de Campinas
RECRUITING

Campinas, São Paulo, 13060-080, Brazil
Institutul de Psihiatrie Socola
RECRUITING

Iași, 700282, Romania
Kingfisher Cooperative
RECRUITING

Spokane, Washington, 99201, United States
Klinicki Bolnicki Centar Rijeka
RECRUITING

Rijeka, 51000, Croatia
Kuramitsu Hospital
RECRUITING

Fukuoka, 819-0037, Japan
L2IP - Instituto de Pesquisas Clínicas
RECRUITING

Brasília, Federal District, 70200730, Brazil
Local Institution - 1001
NOT_YET_RECRUITING

La Plata, Buenos Aires, 1900, Argentina
Local Institution - 1002
NOT_YET_RECRUITING

Mar del Plata, Buenos Aires, B7602CBM, Argentina
Local Institution - 1104
NOT_YET_RECRUITING

Sofia, 1202, Bulgaria
Local Institution - 1150
NOT_YET_RECRUITING

Montreal, Quebec, H4A 3T2, Canada
Local Institution - 1153
NOT_YET_RECRUITING

Hamilton, Ontario, L8M 1W9, Canada
Local Institution - 1201
NOT_YET_RECRUITING

Ioannina, 45500, Greece
Local Institution - 1250
NOT_YET_RECRUITING

Kolkata, West Bengal, 700054, India
Local Institution - 1251
NOT_YET_RECRUITING

Hyderabad, 500034, India
Local Institution - 1252
NOT_YET_RECRUITING

Hyderabad, Telangana, 500082, India
Local Institution - 1253
NOT_YET_RECRUITING

New Delhi, 110029, India
Local Institution - 1254
NOT_YET_RECRUITING

Varanasi, Uttar Pradesh, 221005, India
Local Institution - 1255
NOT_YET_RECRUITING

Ahmedabad, Gujarat, 380060, India
Local Institution - 1256
NOT_YET_RECRUITING

Delhi, 110 095, India
Local Institution - 1308
NOT_YET_RECRUITING

Shimotsuke-shi, Tochigi, 329-0498, Japan
Local Institution - 1350
NOT_YET_RECRUITING

Monterrey, Nuevo León, 66460, Mexico
Local Institution - 1360
NOT_YET_RECRUITING

Mexico City, Mexico City, 14269, Mexico
Local Institution - 1361
NOT_YET_RECRUITING

Mexico City, 10200, Mexico
Local Institution - 1451
WITHDRAWN

Bucharest, 010825, Romania
Local Institution - 1459
WITHDRAWN

Bucharest, 060222, Romania
Local Institution - 1463
NOT_YET_RECRUITING

Bucharest, 011241, Romania
Local Institution - 1464
NOT_YET_RECRUITING

Sibiu, 550052, Romania
Local Institution - 1550
NOT_YET_RECRUITING

Zagreb, City of Zagreb, 10000, Croatia
Local Institution - 1553
NOT_YET_RECRUITING

Zagreb, City of Zagreb, 10000, Croatia
Local Institution - 1555
NOT_YET_RECRUITING

Zagreb, 10 090, Croatia
Local Institution - 1602
NOT_YET_RECRUITING

Miami, Florida, 33122, United States
Local Institution - 1604
COMPLETED

Miami, Florida, 33186, United States
Local Institution - 1608
NOT_YET_RECRUITING

Ocala, Florida, 34471, United States
Local Institution - 1610
NOT_YET_RECRUITING

Inwood, New York, 11096, United States
Local Institution - 1618
NOT_YET_RECRUITING

Miami, Florida, 33135, United States
Local Institution - 1622
NOT_YET_RECRUITING

Maitland, Florida, 32751, United States
Local Institution - 1630
WITHDRAWN

Colorado Springs, Colorado, 80907, United States
Local Institution - 1631
NOT_YET_RECRUITING

Maitland, Florida, 32751, United States
Local Institution - 1637
COMPLETED

La Jolla, California, 92037, United States
Local Institution - 1639
ACTIVE_NOT_RECRUITING

Torrance, California, 90505, United States
Local Institution - 1644
NOT_YET_RECRUITING

Seattle, Washington, 98122, United States
Local Institution - 1645
WITHDRAWN

Woodmere, New York, 11598-1739, United States
Local Institution - 1647
COMPLETED

Middletown, New Jersey, 07748, United States
Local Institution - 1652
WITHDRAWN

Columbia, South Carolina, 29205, United States
Local Institution - 1655
NOT_YET_RECRUITING

Marrero, Louisiana, 70072, United States
Local Institution - 1663
NOT_YET_RECRUITING

Foxborough, Massachusetts, 02035-1309, United States
Local Institution - 1666
NOT_YET_RECRUITING

Merritt Island, Florida, 32952, United States
Local Institution - 1755
WITHDRAWN

London, Ontario, N6A 5W9, Canada
Local Institution - 1800
WITHDRAWN

Shanghai, Shanghai Municipality, 200025, China
Local Institution - 1808
WITHDRAWN

Tianjin, 300350, China
London Health Sciences Centre-Victoria Campus
RECRUITING

London, Ontario, N6A 5W9, Canada
Mayflower Clinical Research
RECRUITING

South Dartmouth, Massachusetts, 02747, United States
Medical Center Medconsult Pleven OOD
RECRUITING

Pleven, 5800, Bulgaria
Medical Center Mladost
RECRUITING

Varna, 9020, Bulgaria
Medical Center Sveti Naum EOOD
RECRUITING

Sofia, 1113, Bulgaria
Mental Health Center of Xi'an City
RECRUITING

Xian, Shanxi, 710061, China
Mid Hudson Medical Research
RECRUITING

New Windsor, New York, 12553, United States
Nanjing Drum Tower hospital
RECRUITING

Nanjing, Jiangsu, 210008, China
National Cheng Kung University Hospital
RECRUITING

Tainan, Taiana, 704, Taiwan
National Hospital Organization Hizen Psychiatric Center
RECRUITING

Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192, Japan
National Taiwan University Hospital
RECRUITING

Taipei, 100229, Taiwan
NeuroBehavioral Medicine Group
RECRUITING

Bloomfield Hills, Michigan, 48302, United States
Neurociencias PRISMA A.C.
RECRUITING

San Luis Potosí City, 78216, Mexico
Nippon Medical School Hospital
RECRUITING

Bunkyo-ku, Tokyo, 113-8603, Japan
Nucleo de Pesquisa Clinica do Rio Grande do Sul
RECRUITING

Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Oakland Medical Research
RECRUITING

Troy, Michigan, 48085, United States
Okayama City General Medical Center Okayama City Hospital
RECRUITING

Okayama, 700-8557, Japan
Ontario Shores Centre For Mental Health Sciences
RECRUITING

Whitby, Ontario, L1N 5S9, Canada
Oroitu CAE
RECRUITING

Getxo, Bizkaia, 48993, Spain
Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova
RECRUITING

Razgrad, 7200, Bulgaria
PUCTrials
RECRUITING

Curitiba, Paraná, 80230-130, Brazil
Peking University Sixth Hospital
RECRUITING

Haidian District, Beijing Municipality, 100191, China
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
RECRUITING

Bucharest, 40874, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041919, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041919, Romania
Progressive Medical Research
RECRUITING

Port Orange, Florida, 32127, United States
Rainbow and Sea Hospital
RECRUITING

Karatsu-shi, Saga-ken, 847-0031, Japan
Redbird Research
RECRUITING

Las Vegas, Nevada, 89119, United States
Ruschel Medicina e Pesquisa Clínica
RECRUITING

Rio de Janeiro, 22270-060, Brazil
Shenzhen Kangning Hospital
RECRUITING

Shenzhen, Guangdong, 518118, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
RECRUITING

Hangzhou, 310016, China
Spitalul de Psihiatrie și Neurologie Brașov
RECRUITING

Sanpetru /Brasov, 507190, Romania
Sunnybrook Research Institute
RECRUITING

Toronto, Ontario, M4N 3M5, Canada
Sunwise Clinical Research
RECRUITING

Walnut Creek, California, 94596, United States
Taipei Veterans General Hospital
RECRUITING

Taipei, 112, Taiwan
Teikyo University Mizonokuchi Hospital
RECRUITING

Kawasaki, Kanagawa, 213-8507, Japan
The Affiliated Brain Hospital of Guangzhou Medical University
RECRUITING

Guangzhou, Guangdong, 0, China
The First Affiliated Hospital of Chongqing Medical University
RECRUITING

Chongqing, Chongqing Municipality, 630014, China
The First Affiliated Hospital of Kunming Medical University
RECRUITING

Kunming, 650032, China
The First Affiliated Hospital of Zhejiang University
RECRUITING

Hangzhou, Zhejiang, 310003, China
The Memory Clinic
RECRUITING

Bennington, Vermont, 05201-9810, United States
The Neurology Group
RECRUITING

Pomona, California, 91767, United States
The Second Affiliated Hospital of Guangzhou Medical University
RECRUITING

Guangzhou, Guangzhou Province, 510260, China
Tianjin Anding Hospital
RECRUITING

Tianjin, Tianjin Municipality, 300074, China
Unidade Local de Saúde de Coimbra, E.P.E.
RECRUITING

Coimbra, 3049, Portugal
Unidade Local de Saúde de Matosinhos SA
RECRUITING

Senhora da Hora, 4464-513, Portugal
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
RECRUITING

Chaïdári, Attikí, 124 62, Greece
University Hospital of Patras
RECRUITING

Pátrai, Achaḯa, 26504, Greece
Wasatch Clinical Research, LLC
RECRUITING

Salt Lake City, Utah, 84107, United States
West China Hospital, Sichuan University
RECRUITING

Chengdu, Sichuan, 610041, China
Xiangya Hospital Central South University
RECRUITING

Changsha, Hunan, 410008, China
Xuanwu Hospital Capital Medical University
RECRUITING

Beijing, Beijing Municipality, 100053, China

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