Alzheimer's DiseasePhase 3NCT07011745
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
A Phase 3 study testing Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 143 sites in 14 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 143 sitesin 14 countries
- Study dates
- 16 Jul 2025to 13 Nov 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- If no historical evidence available:
- A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
- If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
- Amyloid PET.
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- 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:
- Attend all visits and report on participant's status.
- Oversee participant compliance with medication and study procedures.
- 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.
Who cannot join
- Medical Conditions.
- Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- History of bipolar disorder, schizophrenia, or schizoaffective disorder.
- History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
- Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
- Prior/Concomitant Therapy.
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- 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).
- 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.
- 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.
Trial locations and contacts
143 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
143 sites in 14 countries
United States42 sites, 36 recruiting
- Completed
Local Institution - 2618
Ann Arbor, Michigan, 48105
- Recruiting
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328
Vasundhara Cheekati, Site 2611, 404-382-8660
- Recruiting
Visionary Investigators Network
Aventura, Florida, 33180
Jonathan Cross, Site 2648, 305-933-5993
- Withdrawn
Local Institution - 2601
Basalt, Colorado, 81621
- Recruiting
Velocity Clinical Research - Blue Ash
Blue Ash, Ohio, 45242
Babu Gupta, Site 2617, 513-769-2767
- Recruiting
Envision Trials LLC
Bonita Springs, Florida, 34134-4154
Daniel Mandri, Site 2602, 305-819-2909
- Completed
Local Institution - 2612
Bountiful, Utah, 84010
- Recruiting
Key Clinical Research
Bradenton, Florida, 34207
Nicholas Weber, Site 2624, +61736460818
- Not yet recruiting
Local Institution - 2647
Brooklyn, New York, 11229
Site 2647
- Recruiting
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, 75006
Andrea Brown, Site 2616, 972-782-2405
- Recruiting
Chandler Clinical Trials, LLC
Chandler, Arizona, 85224
Ari Magill, Site 2609, 480-382-7909
- Not yet recruiting
Local Institution - 2631
Chandler, Arizona, 85226-3732
Site 2631
- Recruiting
TrialSphere Corp
Chandler, Arizona, 85286
Hemant Pandey, Site 2646, 520-339-6769
- Recruiting
Horizon Clinical Research Center - Houston
Cypress, Texas, 77429
Harpaul Gill, Site 2605, 949-491-0710
- Not yet recruiting
Local Institution - 2636
Doral, Florida, 33122
Site 2636
- Recruiting
National Institute of Clinical Research
Garden Grove, California, 92844
Michael Dao, Site 2625
- Recruiting
Hattiesburg Clinic
Hattiesburg, Mississippi, 39402
Ronald Schwartz, Site 2629, 601-606-0911
- Not yet recruiting
Local Institution - 2606
Homestead, Florida, 33032
Site 2606
- Recruiting
EvergreenHealth Medical Center
Kirkland, Washington, 98034
Pinky Agarwal, Site 2638, 425-899-3123
- Recruiting
Las Vegas Clinical Trials
Las Vegas, Nevada, 89030
Alton Walters, Site 2628, 702-637-3223
- Not yet recruiting
Local Institution - 2607
Long Beach, California, 90805
Site 2607
- Recruiting
Accellacare
Long Beach, California, 90807
Elizabeth Zarate Rowell, Site 2642
- Recruiting
Epic Medical Research, LLC - Mesquite
Mesquite, Texas, 75150
Laquita Shepherd, Site 2622, 972-777-6956
- Recruiting
Miami Jewish health
Miami, Florida, 33137
Marc Agronin, Site 2633, 3057518626x2403
- Not yet recruiting
Local Institution - 2637
Miami, Florida, 33165
Site 2637
- Not yet recruiting
Local Institution - 2610
Milwaukee, Wisconsin, 53226
Site 2610
- Recruiting
West Clinical Research
Morehead City, North Carolina, 28557
Patrick Morgante, Site 2608, 252-515-0050
- Not yet recruiting
Local Institution - 2627
Napa, California, 94558
Site 2627
- Not yet recruiting
Local Institution - 2632
Norwalk, Connecticut, 06851
Site 2632
- Recruiting
ATP Clinical Research
Orange, California, 92866
Gustavo Alva, Site 2649, 949-354-5353
- Not yet recruiting
Local Institution - 2634
Orlando, Florida, 32806
Site 2634
- Completed
Local Institution - 2603
Ozark, Missouri, 65721
- Not yet recruiting
Local Institution - 2613
Pasadena, California, 91105
Site 2613
- Not yet recruiting
Local Institution - 2630
Saint Paul, Minnesota, 55130
Site 2630
- Recruiting
UT Health - San Antonio
San Antonio, Texas, 78229
Antonio Teixeira, Site 2623, 210-567-8229
- Not yet recruiting
Local Institution - 2614
San Diego, California, 92108
Site 2614
- Recruiting
Richmond Behavioral Associates
Staten Island, New York, 10312
Romana Kulikova, Site 2619, 718-619-4403
- Recruiting
IPTB Clinical Research
Tampa, Florida, 33629
Jamie Fernandez, Site 2621, 813-251-1800
- Not yet recruiting
Local Institution - 2650
Toms River, New Jersey, 08755
Site 2650
- Recruiting
Walnut Clinical Research
Valley Stream, New York, 11580
Osher Rechester, Site 2644, 718-407-0225
- Completed
Local Institution - 2620
West Hills, California, 91307
- Completed
Local Institution - 2615
Worcester, Massachusetts, 01608
Ukraine16 sites, 16 recruiting
- Recruiting
MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
Dnipro, Dnipropetrovsk Oblast, 49115
Svitlana Moroz, Site 2554, +380675658914
- Recruiting
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
Hlevakha, Kyiv Oblast, 08631
Gennadii Zilberblat, Site 2566, 380506480750
- Recruiting
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)"
Hlevakha, 08631
Iryna Vrublevskaya, Site 2556, +380504122719
- Recruiting
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
Kropyvnytskyi, 25491
Yevhen Denysov, Site 2550, +380505641035
- Not yet recruiting
Local Institution - 2565
Kyiv, 01030
Site 2565
- Recruiting
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
Kyiv, 04080
Yuliya Blazhevych, Site 2553, +380503847048
- Not yet recruiting
Local Institution - 2560
Lutsk, Volyn Oblast, 43005
Site 2560
- Recruiting
COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, Lviv Oblast, 79021
Yuriy Filts, Site 2552, +380-67-6702827
- Recruiting
"Medical Centre "Neuroclinic" LLC
Lviv, 79035
Lidiya Maryenko, Site 2558, +380-67-7791518
- Recruiting
Limited Liability Company "Iqmed"
Lviv, 79035
Andriy Tsona, Site 2569, +380 67 379 7848
- Recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
Oleksandrivka, Odesa Oblast, 67513
Yevgen Oprya, Site 2567, +380679920420
- Recruiting
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
Poltava, 36013
Andriy Skrypnikov, Site 2557, +380502523300
- Recruiting
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
Skarzhyntsi, Khmelnytskyi Oblast, 32120
Viktoriia Kachynska, Site 2559, 380672624158
- Recruiting
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, Cherkasy Oblast, 20708
Iryna Kosenkova, Site 2555, 380473321979
- Not yet recruiting
Local Institution - 2562
Ternopil, 46027
Site 2562
- Recruiting
Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
Vinnytsia, Vinnytsia Oblast, 21037
Oksana Serebrennikova, Site 2551, +380679605672
South Korea10 sites, 9 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, 41404
Ho-Won Lee, Site 2400, 82532003299
- Recruiting
Inha University Hospital
Incheon, Incheon Gwang'yeogsi, 22332
Seong Hye Choi, Site 2401, +82328902080
- Recruiting
Gachon University Gil Medical Center
Incheon, 405-760
Kee Hyung Park, Site 2409, +82324603346
- Recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Manho Kim, Site 2407, +82-2-2072-2193
- Recruiting
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05030
Seol-Heui Han, Site 2403, +821045057561
- Withdrawn
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], 06351
- Recruiting
Asan Medical Center
Seoul, 05505
Jae-Sung Lim, Site 2402, 0000000000
- Recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Hanna Cho, Site 2408
- Recruiting
SMG-SNU Borame Medical Center
Seoul, 07061
Jun-Young Lee, Site 2405, 8228702462
- Recruiting
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
Hyun-Kook Lim, Site 2404, 82216617575
United Kingdom10 sites, 9 recruiting
- Not yet recruiting
Local Institution - 2502
Cambridge, CB21 5EF
Site 2502
- Recruiting
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey, KT16 9AU
Ramin Nilforooshan, Site 2508, +44 300 555 5222
- Recruiting
South London and Maudsley NHS Foundation Trust
London, SE5 8AZ
Dag Aarsland, Site 2501, +44 800 731 2864
- Not yet recruiting
Local Institution - 2500
London, W12 0NN
Site 2500
- Recruiting
NeuroClin Glasgow
Motherwell, ML1 4UF
Jennifer Lynch, Site 2510, +44 141 948 0206
- Recruiting
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, PR2 9HT
Salman Karim, Site 2505, +44 1772 522972
- Recruiting
Cornwall Partnership NHS Foundation Trust
Redruth, TR15 3QE
Nicholas Jacobsen, Site 2507, +44 1208 251 300
- Recruiting
Sheffield Health and Social care NHS Foundation Trust
Sheffield, S5 7JT
Aparna Mordekar, Site 2504, +44 114 226 1600
- Withdrawn
Local Institution - 2509
Stafford, ST16 3SR
- Recruiting
Black Country Healthcare NHS Foundation Trust
Wolverhampton, WV4 5HN
Luay Kafienah, Site 2503, +44 1902 444141
Czechia9 sites, 7 recruiting
- Recruiting
Neuro Health Centrum s.r.o.
Brno, South Moravian, 628 00
Katerina Sheardova, Site 2103, +420603198029
- Recruiting
NEUROHK
Choceň, 565 01
Martin Valis, Site 2101, +420495835233
- Recruiting
AGE Centrum
Olomouc, Olomouc Region, 779 00
Dagmar Malotova, Site 2107, 00420723060809
- Recruiting
A-SHINE s.r.o.
Pilsen, 301 00
Lubos Janu, Site 2104, 420777242101
- Recruiting
Neuropsychiatrie
Prague, Praha 6, 160 00
Jakub Hort, Site 2100, +420224434700
- Recruiting
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, 18600
Alexander Nawka, Site 2106, +420605809745
- Withdrawn
Local Institution - 2102
Prague, 100 000
- Withdrawn
Local Institution - 2105
Prague, 100 00
- Recruiting
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 516 01
Ladislav Pazdera, Site 2108, 420604236033
Poland9 sites, 6 recruiting
- Recruiting
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163
Pawel Lisewski, Site 2454, 0048698619497
- Recruiting
M2M Med
Chorzów, 41-500
Anna Starostka-Tatar, Site 2456, +48518424470
- Completed
Local Institution - 2455
Katowice, 40-146
- Not yet recruiting
Local Institution - 2458
Krakow, 31-505
Site 2458
- Withdrawn
Local Institution - 2451
Lublin, 20-064
- Withdrawn
Local Institution - 2452
Lublin, 20-064
- Recruiting
Centrum Medyczne HCP Szpital im. Jana Pawla II
Poznan, Greater Poland Voivodeship, 61-485
Przemyslaw Osip, Site 2450, +48604116632
- Recruiting
RCMed Oddzial Sochaczew
Sochaczew, 96-500
Małgorzata Fengler-Czeczko, Site 2453, +48 697 777 777
- Not yet recruiting
Local Institution - 2457
Wroclaw, 53-659
Site 2457
Hungary8 sites, 4 recruiting
- Not yet recruiting
Local Institution - 2256
Budapest, 1033
Site 2256
- Not yet recruiting
Local Institution - 2255
Budapest, 1036
Site 2255
- Withdrawn
Local Institution - 2251
Budapest, 1083
- Recruiting
Semmelweis Egyetem
Budapest, 1083
Tibor Kovacs, Site 2253, +36 20 825 0367
- Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4031
Palma Piros, Site 2252, 36206207623
- Withdrawn
Local Institution - 2254
Gyöngyös, 3200
- Withdrawn
Local Institution - 2250
Győr, Győr-Moson-Sopron, 0
- Withdrawn
Local Institution - 2257
Kalocsa, Bács-Kiskun county, 6300
Italy8 sites, 7 recruiting
- Recruiting
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
Salvatore Caratozzolo, Site 2356, +393930406304
- Withdrawn
Local Institution - 2355
Isernia, 86077
- Recruiting
Auxologico IRCCS - Auxologico San Luca
Milan, Lombardy, 20149
Nicola Ticozzi, Site 2353, 3902619112937
- Recruiting
University of Naples Federico II
Naples, Campania, 80131
Vincenzo Brescia Morra, Site 2351, +39081743741
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, 56126
giulio perugi, Site 2350, +39335435387
- Recruiting
Fondazione Policlinico Gemelli IRCCS
Roma, 00168
Francesco Landi, Site 2357, +39 0630154859
- Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
Rome, Lazio, 00185
Giuseppe Bruno, Site 2354, 3988888888x88
- Recruiting
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Lazio, 00189
Franco Giubilei, Site 2352, 390633775630
Argentina7 sites, 7 recruiting
- Recruiting
Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM
Buenos Aires, 1133
Ricardo Corral, Site 2006, 5491144455572
- Recruiting
Hospital Italiano de Buenos Aires (HIBA)
Buenos Aires, 1199
José Faccioli, Site 2004, +5491157934078
- Recruiting
Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1058
Enrique Kuper, Site 2005, 541143000000
- Recruiting
Instituto Modelo de Neurología, Fundación Lennox
Córdoba, 5000
Georgina Viczena, Site 2000, +5493515993881
- Recruiting
Sanatorio Morra S.A.
Córdoba, 5000
Carlos Morra, Site 2002, 5493516858696
- Recruiting
Instituto Médico DAMIC
Córdoba, X5003DCE
Gerardo Garcia Bonetto, Site 2003, +5493516508068
- Recruiting
Resolution Psychopharmacology Research Institute
Mendoza, 5502
Eugenio Velasco, Site 2001, 54-261-9-155861633
France7 sites, 7 recruiting
- Recruiting
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, 59037
Lionel Trogneux, Site 2153, 0320446021
- Recruiting
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, 87042
Achille Tchalla, Site 2156, +555058262
- Recruiting
Hopital Gui Chauliac - Chu Montpellier
Montpellier, 34295
Karim Bennys, Site 2157, 33467336029
- Recruiting
Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location
Paris, 75010
Emmanuel COGNAT, Site 2152
- Recruiting
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, 67091
Alix RAVIER, Site 2155, +33388115844
- Recruiting
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, 31000
Maria Eugenia Soto-Martin, Site 2150
- Recruiting
Hôpital des Charpennes - Hospices Civils de Lyon (HCL)
Villeurbanne, Rhône, 69100
Antoine Garnier-Crussard, Site 2151
Chile6 sites, 6 recruiting
- Recruiting
Psicomed Estudios Médicos Cía Ltda
Antofagasta, 1270244
Luis Alberto Barra Ahumada, Site 2053, 5655240334
- Recruiting
Biomedica Research Group
Santiago, Santiago Metropolitan, 7500710
Sergio Gloger, Site 2051, +56982945977
- Not yet recruiting
Local Institution - 2050
Santiago, Santiago Metropolitan, 7560356
Site 2050
- Recruiting
Pontificia Universidad Catolica de Chile
Santiago, Santiago Metropolitan, 8330024
Rodrigo Santibanez Moreira, Site 2052, 56940920180
- Not yet recruiting
Local Institution - 2055
Viña del Mar, Valparaiso, 2511433
Site 2055
- Recruiting
Clinica Alemana
Vitacura, Santiago Metropolitan, 2511433
Rafael Aranguiz, Site 2054, 005622910 2853
Israel5 sites, 5 recruiting
- Recruiting
Sanz MC, Laniado Hospital
Netanya, 4244916
Vered Hermush, Site 2303
- Not yet recruiting
Local Institution - 2302
Petch Tikva, IL, 49100
Site 2302
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan, Central District, 5262000
Ramit Ravona-Springer, Site 2305
- Recruiting
The Israeli Alzheimer Medical Center
Ramat Gan, 5265601
Mark Weiser, Site 2300, 0526666570
- Recruiting
Bayit Balev Ltd.
Rishon Le'Tzion, 7590653
Gisele Sasson, Site 2304
Germany3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 2201
Düsseldorf, 40221
Site 2201
- Not yet recruiting
Local Institution - 2205
Halle, 06120
Site 2205
- Not yet recruiting
Local Institution - 2206
Westerstede, 26655
Site 2206
Puerto Rico3 sites, 3 recruiting
- Recruiting
CMRC Headlands
San Juan, 00918
Vanessa Sepulveda, Site 2645, 1-787-679-3324
- Recruiting
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, 00918
Ivonne De L Fraga Berrios, Site 2640, 7874035534
- Not yet recruiting
Local Institution - 2639
San Juan, 00918
Site 2639
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo
- Keywords
- Alzheimer's Disease (AD), Agitation, ADAGIO, KarXT, KarX-EC
- Medical subject headings
- Alzheimer Disease, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline/Trospium Chloride CapsuleDrug
Also called KarXT, BMS-986510
Specified dose on specified days
Xanomeline Enteric CapsuleDrug
Also called KarX-EC, BMS-986519
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT + KarX-EC | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14
Measured: At Week 14
Secondary outcomes (20)
Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14
Measured: At Week 14
Change from baseline on CMAI-IPA Domains at Week 14
Measured: At Week 14
Change from baseline on CMAI Total Score at Week 14
Measured: At Week 14
Number of participants with Occurrence of Response at Week 14
As determined by CMAI-IPA changes of at least 30%, 40%, and 50% from baseline
Measured: At Week 14
Change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14
Measured: At Week 14
Number of participants with Adverse Events (AEs)
Measured: Up to Week 18
Number of participants with Treatment Emergent AEs (TEAEs)
Measured: Up to Week 18
Number of participants with Serious AEs (SAEs)
Measured: Up to Week 18
Number of participants with AEs leading to study drug withdrawal
Measured: Up to Week 18
Number of deaths
Measured: Up to Week 18
Number of participants with AEs of Special Interest (AESIs)
Measured: Up to Week 18
Barnes Akathisia Rating Scale (BARS)
Measured: Up to Week 14
Abnormal Involuntary Movement Scale (AIMS)
Measured: Up to Week 14
Body weight
Measured: Up to Week 14
Body Mass Index (BMI)
Measured: Up to Week 14
Number of participants with vital sign abnormalities
Measured: Up to Week 18
Number of participants with clinical laboratory abnormalities
Measured: Up to Week 14
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Week 14
Number of participants with suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Week 18
Severity of benign prostatic hyperplasia in male participants as assessed by International Prostate Symptom Score (IPSS)
Measured: Up to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start16 Jul 2025
- Primary completion3 Nov 2028 (estimated)
- Study completion13 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011745
- Sponsor's protocol ID
- CN012-0024
- Other IDs
- 2025-520612-34, U1111-1316-5827, 2025
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html