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

NCT ID NCT07011745

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

First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 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.

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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

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
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
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 - 2002
NOT_YET_RECRUITING

Córdoba, 5000, Argentina
Local Institution - 2004
NOT_YET_RECRUITING

Buenos Aires, 1199, 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
NOT_YET_RECRUITING

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
ACTIVE_NOT_RECRUITING

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 - 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 - 2633
NOT_YET_RECRUITING

Miami, Florida, 33137, United States
Local Institution - 2634
NOT_YET_RECRUITING

Orlando, Florida, 32806, United States
Local Institution - 2635
NOT_YET_RECRUITING

Colorado Springs, Colorado, 80907, 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 - 2641
NOT_YET_RECRUITING

San Juan, 00917, Puerto Rico
Local Institution - 2646
NOT_YET_RECRUITING

Chandler, Arizona, 85286, United States
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 - 2649
NOT_YET_RECRUITING

Orange, California, 92866, 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
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
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
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
Vitalix Clinical
RECRUITING

Worcester, Massachusetts, 01608, United States
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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