A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)
NCT ID: NCT07011745
Last Updated: 2026-01-27
Study Results
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Basic Information
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RECRUITING
PHASE3
352 participants
INTERVENTIONAL
2025-07-16
2028-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KarXT + KarX-EC
Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 5 to 22, inclusive, at Screening (Visit 1).
* Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) 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).
* CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
* At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):
i) 1 or more aggressive behaviors occurring at least several times per week.
ii) 2 or more aggressive behaviors occurring at least once or twice per week.
iii) 3 or more aggressive behaviors occurring less than once per week.
Exclusion Criteria
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. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
55 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Chandler Clinical Trials, LLC
Chandler, Arizona, United States
Local Institution - 2631
Chandler, Arizona, United States
Local Institution - 2625
Long Beach, California, United States
Local Institution - 2607
Long Beach, California, United States
Local Institution - 2642
Long Beach, California, United States
Local Institution - 2627
Napa, California, United States
Local Institution - 2613
Pasadena, California, United States
Local Institution - 2614
San Diego, California, United States
Alliance Clinical -West Hills
West Hills, California, United States
Local Institution - 2601
Basalt, Colorado, United States
Local Institution - 2635
Colorado Springs, Colorado, United States
Local Institution - 2632
Norwalk, Connecticut, United States
Envision Trials LLC
Bonita Springs, Florida, United States
Key Clinical Research
Bradenton, Florida, United States
Local Institution - 2636
Doral, Florida, United States
Local Institution - 2626
Hialeah, Florida, United States
Local Institution - 2606
Homestead, Florida, United States
Local Institution - 2633
Miami, Florida, United States
Local Institution - 2637
Miami, Florida, United States
Local Institution - 2634
Orlando, Florida, United States
IPTB Clinical Research
Tampa, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Vitalix Clinical
Worcester, Massachusetts, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
Local Institution - 2630
Saint Paul, Minnesota, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Sharlin Health Neuroscience Research Center
Ozark, Missouri, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Richmond Behavioral Associates
Staten Island, New York, United States
West Clinical Research
Morehead City, North Carolina, United States
Velocity Clinical Research - Blue Ash
Blue Ash, Ohio, United States
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, United States
Local Institution - 2605
Cypress, Texas, United States
Epic Medical Research, LLC - Mesquite
Mesquite, Texas, United States
Local Institution - 2623
San Antonio, Texas, United States
Pantheon Clinical Research, LLC
Bountiful, Utah, United States
Local Institution - 2638
Kirkland, Washington, United States
Local Institution - 2610
Milwaukee, Wisconsin, United States
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 2006
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 2004
Buenos Aires, , Argentina
Local Institution - 2000
Córdoba, , Argentina
Local Institution - 2002
Córdoba, , Argentina
Local Institution - 2003
Córdoba, , Argentina
Local Institution - 2001
Mendoza, , Argentina
Local Institution - 2055
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 2051
Santiago, Santiago Metropolitan, Chile
Local Institution - 2050
Santiago, Santiago Metropolitan, Chile
Local Institution - 2052
Santiago, Santiago Metropolitan, Chile
Local Institution - 2054
Vitacura, Santiago Metropolitan, Chile
Local Institution - 2053
Antofagasta, , Chile
Local Institution - 2107
Olomouc, Olomoucký kraj, Czechia
Neuropsychiatrie
Prague, Praha 6, Czechia
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, Czechia
Neuro Health Centrum s.r.o.
Brno, South Moravian, Czechia
NEUROHK
Choceň, , Czechia
A-SHINE s.r.o.
Pilsen, , Czechia
Local Institution - 2102
Prague, , Czechia
Local Institution - 2105
Prague, , Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, , Czechia
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, France
Local Institution - 2151
Villeurbanne, Rhône, France
Local Institution - 2153
Lille, , France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, , France
Local Institution - 2157
Montpellier, , France
Local Institution - 2152
Paris, , France
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, , France
Local Institution - 2203
Erbach im Odenwald, Hesse, Germany
Local Institution - 2201
Düsseldorf, , Germany
Local Institution - 2205
Halle, , Germany
Local Institution - 2206
Westerstede, , Germany
Local Institution - 2257
Kalocsa, Bács-Kiskun county, Hungary
Local Institution - 2250
Győr, Győr-Moson-Sopron, Hungary
Local Institution - 2254
Gyöngyös, Heves County, Hungary
Local Institution - 2256
Budapest, , Hungary
Local Institution - 2255
Budapest, , Hungary
Local Institution - 2251
Budapest, , Hungary
Local Institution - 2253
Budapest, , Hungary
Local Institution - 2252
Debrecen, , Hungary
The Chaim Sheba Medical Center
Ramat Gan, Central District, Israel
Local Institution - 2302
Petch Tikva, IL, Israel
Local Institution - 2301
Jerusalem, , Israel
Sanz MC, Laniado Hospital
Netanya, , Israel
The Israeli Alzheimer Medical Center
Ramat Gan, , Israel
Bayit Balev Ltd.
Rishon Le'Tzion, , Israel
University of Naples Federico II
Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
Rome, Lazio, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Lazio, Italy
Auxologico IRCCS - Auxologico San Luca
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, , Italy
Local Institution - 2355
Isernia, , Italy
Fondazione Policlinico Gemelli IRCCS
Roma, , Italy
Centrum Medyczne HCP Szpital im. Jana Pawla II
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 2454
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
M2M Med
Chorzów, , Poland
Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii
Katowice, , Poland
Local Institution - 2451
Lublin, , Poland
Local Institution - 2452
Lublin, , Poland
RCMed Oddzial Sochaczew
Sochaczew, , Poland
Local Institution - 2641
San Juan, , Puerto Rico
Local Institution - 2640
San Juan, , Puerto Rico
Local Institution - 2639
San Juan, , Puerto Rico
Inha University Hospital
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Asan Medical Center
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
SMG-SNU Borame Medical Center
Seoul, , South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, , South Korea
Local Institution - 2555
Smila, Cherkasy Oblast, Ukraine
Local Institution - 2554
Dnipro, Dnipropetrovsk Oblast, Ukraine
Local Institution - 2561
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Local Institution - 2559
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine
Local Institution - 2556
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 2566
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 2553
Kyiv, Kyivska Oblast, Ukraine
Local Institution - 2552
Lviv, Lviv Oblast, Ukraine
Local Institution - 2558
Lviv, Lviv Oblast, Ukraine
Local Institution - 2569
Lviv, Lviv Oblast, Ukraine
Local Institution - 2567
Oleksandrivka, Odesa Oblast, Ukraine
Local Institution - 2557
Poltava, Poltava Oblast, Ukraine
Local Institution - 2551
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 2560
Lutsk, Volyn Oblast, Ukraine
Local Institution - 2550
Kropyvnytskyi, , Ukraine
Local Institution - 2565
Kyiv, , Ukraine
Local Institution - 2568
Odesa, , Ukraine
Local Institution - 2505
Preston, Lancashire, United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey, United Kingdom
Local Institution - 2502
Cambridge, , United Kingdom
South London and Maudsley NHS Foundation Trust
London, , United Kingdom
Local Institution - 2500
London, , United Kingdom
NeuroClin Glasgow
Motherwell, , United Kingdom
Cornwall Partnership NHS Foundation Trust
Redruth, , United Kingdom
Local Institution - 2504
Sheffield, , United Kingdom
Local Institution - 2509
Stafford, , United Kingdom
Local Institution - 2503
Wolverhampton, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Ari Magill, Site 2609
Role: primary
Site 2631
Role: primary
Site 2625
Role: primary
Site 2607
Role: primary
Site 2642
Role: primary
Site 2627
Role: primary
Site 2613
Role: primary
Site 2614
Role: primary
Leon Barkodar, Site 2620
Role: primary
Site 2635
Role: primary
Site 2632
Role: primary
Daniel Mandri, Site 2602
Role: primary
Nicholas Weber, Site 2624
Role: primary
Site 2636
Role: primary
Site 2626
Role: primary
Site 2606
Role: primary
Site 2633
Role: primary
Site 2637
Role: primary
Site 2634
Role: primary
Jamie Fernandez, Site 2621
Role: primary
Vasundhara Cheekati, Site 2611
Role: primary
James Carroll, Site 2615
Role: primary
Ravi Kirbat, Site 2618
Role: primary
Site 2630
Role: primary
Ronald Schwartz, Site 2629
Role: primary
Kenneth Sharlin, Site 2603
Role: primary
Alton Walters, Site 2628
Role: primary
Romana Kulikova, Site 2619
Role: primary
Patrick Morgante, Site 2608
Role: primary
Babu Gupta, Site 2617
Role: primary
Andrea Brown, Site 2616
Role: primary
Site 2605
Role: primary
Laquita Shepherd, Site 2622
Role: primary
Site 2623
Role: primary
Jackson Rhudy, Site 2612
Role: primary
Site 2638
Role: primary
Site 2610
Role: primary
Site 2005
Role: primary
Site 2006
Role: primary
Site 2004
Role: primary
Site 2000
Role: primary
Site 2002
Role: primary
Site 2003
Role: primary
Site 2001
Role: primary
Site 2055
Role: primary
Site 2051
Role: primary
Site 2050
Role: primary
Site 2052
Role: primary
Site 2054
Role: primary
Site 2053
Role: primary
Site 2107
Role: primary
Jakub Hort, Site 2100
Role: primary
Alexander Nawka, Site 2106
Role: primary
Katerina Sheardova, Site 2103
Role: primary
Martin Valis, Site 2101
Role: primary
Lubos Janu, Site 2104
Role: primary
Ladislav Pazdera, Site 2108
Role: primary
Maria Eugenia Soto-Martin, Site 2150
Role: primary
Site 2151
Role: primary
Site 2153
Role: primary
Achille Tchalla, Site 2156
Role: primary
Site 2157
Role: primary
Site 2152
Role: primary
Alix RAVIER, Site 2155
Role: primary
Site 2203
Role: primary
Site 2201
Role: primary
Site 2205
Role: primary
Site 2206
Role: primary
Site 2257
Role: primary
Site 2250
Role: primary
Site 2254
Role: primary
Site 2256
Role: primary
Site 2255
Role: primary
Site 2253
Role: primary
Site 2252
Role: primary
Ramit Ravona-Springer, Site 2305
Role: primary
Site 2302
Role: primary
Site 2301
Role: primary
Vered Hermush, Site 2303
Role: primary
Mark Weiser, Site 2300
Role: primary
Gisele Sasson, Site 2304
Role: primary
Vincenzo Brescia Morra, Site 2351
Role: primary
Giuseppe Bruno, Site 2354
Role: primary
Franco Giubilei, Site 2352
Role: primary
Nicola Ticozzi, Site 2353
Role: primary
giulio perugi, Site 2350
Role: primary
Salvatore Caratozzolo, Site 2356
Role: primary
Francesco Landi, Site 2357
Role: primary
Przemyslaw Osip, Site 2450
Role: primary
Site 2454
Role: primary
Anna Starostka-Tatar, Site 2456
Role: primary
Agnieszka Prymus, Site 2455
Role: primary
Site 2451
Role: primary
Małgorzata Fengler-Czeczko, Site 2453
Role: primary
Site 2641
Role: primary
Site 2640
Role: primary
Site 2639
Role: primary
Seong Hye Choi, Site 2401
Role: primary
Manho Kim, Site 2407
Role: primary
Seol-Heui Han, Site 2403
Role: primary
Ho-Won Lee, Site 2400
Role: primary
Kee Hyung Park, Site 2409
Role: primary
Jae-Sung Lim, Site 2402
Role: primary
Hanna Cho, Site 2408
Role: primary
Jun-Young Lee, Site 2405
Role: primary
Hyun-Kook Lim, Site 2404
Role: primary
Site 2555
Role: primary
Site 2554
Role: primary
Site 2561
Role: primary
Site 2559
Role: primary
Site 2556
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Site 2566
Role: primary
Site 2553
Role: primary
Site 2552
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Site 2558
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Site 2569
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Site 2567
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Site 2557
Role: primary
Site 2551
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Site 2560
Role: primary
Site 2550
Role: primary
Site 2565
Role: primary
Site 2568
Role: primary
Site 2505
Role: primary
Ramin Nilforooshan, Site 2508
Role: primary
Site 2502
Role: primary
Dag Aarsland, Site 2501
Role: primary
Site 2500
Role: primary
Jennifer Lynch, Site 2510
Role: primary
Nicholas Jacobsen, Site 2507
Role: primary
Site 2504
Role: primary
Site 2503
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-520613-31
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1316-5745
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0024
Identifier Type: -
Identifier Source: org_study_id
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