Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for Agitation in Alzheimer's Disease
Led by Bristol-Myers Squibb · Updated on 2026-06-03
352
Participants Needed
140
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a combination treatment called KarXT and KarX-EC for adults aged 55 to 90 who have agitation linked to Alzheimer's Disease. This Phase 3 study aims to understand how this treatment may help manage agitation symptoms in this population, with careful monitoring of side effects and overall safety. Participants will receive either the KarXT plus KarX-EC treatment or a placebo, with doses given on specified days as capsules. The study is randomized and double-blind, meaning neither participants nor researchers know who receives the active treatment or placebo. The treatment period lasts 14 weeks, during which participants are closely observed. During the study, participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) score to measure agitation changes at week 14. Additional evaluations include clinical global impressions, neuropsychiatric inventories, safety monitoring through lab tests, vital signs, body measurements, and assessment of side effects up to week 18. Caregivers will also report on participants' status, and safety will be closely followed throughout the trial.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 90 years
- Diagnosed with Alzheimer's disease according to 2024 Alzheimer's Association criteria confirmed by approved biomarker tests
- Mini-Mental State Examination (MMSE) score between 5 and 22 at screening
- History of agitation meeting International Psychogeriatric Association criteria for at least two weeks prior to screening
- Neuropsychiatric Inventory (NPI/NPI-NH) Agitation/Aggression score of 4 or higher at screening and baseline
- Clinical Global Impressions-Severity (CGI-S) score of 4 or higher related to agitation at screening and baseline
- At least one caregiver with about 10 hours or more weekly contact willing to attend visits and assist with study procedures
You will not qualify if you...
- Agitation mainly caused by conditions other than Alzheimer's disease
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
- Risk of suicidal behavior as assessed by clinical evaluation
- Recent use of monoamine oxidase inhibitors, anticonvulsants, mood stabilizers, tricyclic antidepressants, or other psychoactive medications except certain stable antidepressants and hypnotics
- Other protocol-defined exclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 weeks
Participants receive specified doses of KarXT + KarX-EC or placebo for agitation associated with Alzheimer's disease.
Regular visits during treatment period
Duration - Up to 4 weeks after treatment
Participants are monitored for safety and adverse events after treatment ends.
Visits up to Week 18
Trial Site Locations
Total: 140 locations
1
Chandler Clinical Trials, LLC
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Local Institution - 2631
Chandler, Arizona, United States, 85226-3732
Not Yet Recruiting
3
Local Institution - 2646
Chandler, Arizona, United States, 85286
Not Yet Recruiting
4
National Institute of Clinical Research
Garden Grove, California, United States, 92844
Actively Recruiting
5
Local Institution - 2607
Long Beach, California, United States, 90805
Not Yet Recruiting
6
Accellacare
Long Beach, California, United States, 90807
Actively Recruiting
7
Local Institution - 2627
Napa, California, United States, 94558
Not Yet Recruiting
8
Local Institution - 2613
Pasadena, California, United States, 91105
Not Yet Recruiting
9
Local Institution - 2614
San Diego, California, United States, 92108
Not Yet Recruiting
10
Local Institution - 2620
West Hills, California, United States, 91307
Active, Not Recruiting
11
Local Institution - 2601
Basalt, Colorado, United States, 81621
Withdrawn
12
Local Institution - 2635
Colorado Springs, Colorado, United States, 80907
Not Yet Recruiting
13
Local Institution - 2632
Norwalk, Connecticut, United States, 06851
Not Yet Recruiting
14
Envision Trials LLC
Bonita Springs, Florida, United States, 34134-4154
Actively Recruiting
15
Key Clinical Research
Bradenton, Florida, United States, 34207
Actively Recruiting
16
Local Institution - 2636
Doral, Florida, United States, 33122
Not Yet Recruiting
17
Local Institution - 2606
Homestead, Florida, United States, 33032
Not Yet Recruiting
18
Local Institution - 2633
Miami, Florida, United States, 33137
Not Yet Recruiting
19
Local Institution - 2637
Miami, Florida, United States, 33165
Not Yet Recruiting
20
Local Institution - 2634
Orlando, Florida, United States, 32806
Not Yet Recruiting
21
IPTB Clinical Research
Tampa, Florida, United States, 33629
Actively Recruiting
22
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States, 30328
Actively Recruiting
23
Vitalix Clinical
Worcester, Massachusetts, United States, 01608
Actively Recruiting
24
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
25
Local Institution - 2630
Saint Paul, Minnesota, United States, 55130
Not Yet Recruiting
26
Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39402
Actively Recruiting
27
Local Institution - 2603
Ozark, Missouri, United States, 65721
Active, Not Recruiting
28
Las Vegas Clinical Trials
Las Vegas, Nevada, United States, 89030
Actively Recruiting
29
Richmond Behavioral Associates
Staten Island, New York, United States, 10312
Actively Recruiting
30
Local Institution - 2644
Valley Stream, New York, United States, 11580
Not Yet Recruiting
31
West Clinical Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
32
Velocity Clinical Research - Blue Ash
Blue Ash, Ohio, United States, 45242
Actively Recruiting
33
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, United States, 75006
Actively Recruiting
34
Horizon Clinical Research Center - Houston
Cypress, Texas, United States, 77065
Actively Recruiting
35
Epic Medical Research, LLC - Mesquite
Mesquite, Texas, United States, 75150
Actively Recruiting
36
UT Health - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
37
Local Institution - 2612
Bountiful, Utah, United States, 84010
Active, Not Recruiting
38
EvergreenHealth Medical Center
Kirkland, Washington, United States, 98034
Actively Recruiting
39
Local Institution - 2610
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
40
Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1058
Actively Recruiting
41
Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM
Buenos Aires, Argentina, 1133
Actively Recruiting
42
Local Institution - 2004
Buenos Aires, Argentina, 1199
Not Yet Recruiting
43
Instituto Modelo de Neurología, Fundación Lennox
Córdoba, Argentina, 5000
Actively Recruiting
44
Local Institution - 2002
Córdoba, Argentina, 5000
Not Yet Recruiting
45
Instituto Médico DAMIC
Córdoba, Argentina, X5003DCE
Actively Recruiting
46
Resolution Psychopharmacology Research Institute
Mendoza, Argentina, 5502
Actively Recruiting
47
Local Institution - 2051
Santiago, Santiago Metropolitan, Chile, 7500710
Not Yet Recruiting
48
Local Institution - 2050
Santiago, Santiago Metropolitan, Chile, 7560356
Not Yet Recruiting
49
Local Institution - 2052
Santiago, Santiago Metropolitan, Chile, 8330024
Not Yet Recruiting
50
Local Institution - 2054
Vitacura, Santiago Metropolitan, Chile, 2511433
Not Yet Recruiting
51
Local Institution - 2055
Viña del Mar, Valparaiso, Chile, 2511433
Not Yet Recruiting
52
Local Institution - 2053
Antofagasta, Chile, 1270244
Not Yet Recruiting
53
AGE Centrum
Olomouc, Olomouc Region, Czechia, 779 00
Actively Recruiting
54
Neuropsychiatrie
Prague, Praha 6, Czechia, 160 00
Actively Recruiting
55
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, Czechia, 18600
Actively Recruiting
56
Neuro Health Centrum s.r.o.
Brno, South Moravian, Czechia, 628 00
Actively Recruiting
57
NEUROHK
Choceň, Czechia, 565 01
Actively Recruiting
58
A-SHINE s.r.o.
Pilsen, Czechia, 301 00
Actively Recruiting
59
Local Institution - 2102
Prague, Czechia, 100 000
Withdrawn
60
Local Institution - 2105
Prague, Czechia, 100 00
Withdrawn
61
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, Czechia, 516 01
Actively Recruiting
62
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, France, 31000
Actively Recruiting
63
Hôpital des Charpennes - Hospices Civils de Lyon (HCL)
Villeurbanne, Rhône, France, 69100
Actively Recruiting
64
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, France, 59037
Actively Recruiting
65
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, France, 87042
Actively Recruiting
66
Hopital Gui Chauliac - Chu Montpellier
Montpellier, France, 34295
Actively Recruiting
67
Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location
Paris, France, 75010
Actively Recruiting
68
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, France, 67091
Actively Recruiting
69
Local Institution - 2201
Düsseldorf, Germany, 40221
Not Yet Recruiting
70
Local Institution - 2205
Halle, Germany, 06120
Not Yet Recruiting
71
Local Institution - 2206
Westerstede, Germany, 26655
Not Yet Recruiting
72
Local Institution - 2257
Kalocsa, Bács-Kiskun county, Hungary, 6300
Not Yet Recruiting
73
Local Institution - 2250
Győr, Győr-Moson-Sopron, Hungary, 0
Not Yet Recruiting
74
Local Institution - 2254
Gyöngyös, Heves County, Hungary, 3200
Not Yet Recruiting
75
Local Institution - 2256
Budapest, Hungary, 1033
Not Yet Recruiting
76
Local Institution - 2255
Budapest, Hungary, 1036
Not Yet Recruiting
77
Local Institution - 2251
Budapest, Hungary, 1083
Withdrawn
78
Semmelweis Egyetem
Budapest, Hungary, 1083
Actively Recruiting
79
Local Institution - 2252
Debrecen, Hungary, 4032
Not Yet Recruiting
80
The Chaim Sheba Medical Center
Ramat Gan, Central District, Israel, 5262000
Actively Recruiting
81
Local Institution - 2302
Petch Tikva, IL, Israel, 49100
Not Yet Recruiting
82
Sanz MC, Laniado Hospital
Netanya, Israel, 4244916
Actively Recruiting
83
The Israeli Alzheimer Medical Center
Ramat Gan, Israel, 5265601
Actively Recruiting
84
Bayit Balev Ltd.
Rishon Le'Tzion, Israel, 7590653
Actively Recruiting
85
University of Naples Federico II
Naples, Campania, Italy, 80131
Actively Recruiting
86
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
Rome, Lazio, Italy, 00185
Actively Recruiting
87
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Lazio, Italy, 00189
Actively Recruiting
88
Auxologico IRCCS - Auxologico San Luca
Milan, Lombardy, Italy, 20149
Actively Recruiting
89
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy, 56126
Actively Recruiting
90
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy, 25123
Actively Recruiting
91
Local Institution - 2355
Isernia, Italy, 86077
Withdrawn
92
Fondazione Policlinico Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
93
Centrum Medyczne HCP Szpital im. Jana Pawla II
Poznan, Greater Poland Voivodeship, Poland, 61-485
Actively Recruiting
94
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-163
Actively Recruiting
95
M2M Med
Chorzów, Poland, 41-500
Actively Recruiting
96
Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii
Katowice, Poland, 40-146
Actively Recruiting
97
Local Institution - 2451
Lublin, Poland, 20-064
Withdrawn
98
Local Institution - 2452
Lublin, Poland, 20-064
Withdrawn
99
RCMed Oddzial Sochaczew
Sochaczew, Poland, 96-500
Actively Recruiting
100
Local Institution - 2641
San Juan, Puerto Rico, 00917
Not Yet Recruiting
101
Instituto De Neurologia Dra. Ivonne Fraga
San Juan, Puerto Rico, 00918
Actively Recruiting
102
Local Institution - 2639
San Juan, Puerto Rico, 00918
Not Yet Recruiting
103
Local Institution - 2645
San Juan, Puerto Rico, 00918
Not Yet Recruiting
104
Inha University Hospital
Incheon, Incheon Gwang'yeogsi, South Korea, 22332
Actively Recruiting
105
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
Actively Recruiting
106
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05030
Actively Recruiting
107
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
Withdrawn
108
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, South Korea, 41404
Actively Recruiting
109
Gachon University Gil Medical Center
Incheon, South Korea, 405-760
Actively Recruiting
110
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
111
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea, 06273
Actively Recruiting
112
SMG-SNU Borame Medical Center
Seoul, South Korea, 07061
Actively Recruiting
113
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, South Korea, 07345
Actively Recruiting
114
CNCE "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, Cherkasy Oblast, Ukraine, 20708
Actively Recruiting
115
MNCC Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
Actively Recruiting
116
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
Actively Recruiting
117
CNCE of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
Hlevakha, Kyiv Oblast, Ukraine, 08631
Actively Recruiting
118
CNCE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, Lviv Oblast, Ukraine, 79021
Actively Recruiting
119
CNCE "Odesa Regional Mental Health Medical Center" of the ORC"
Oleksandrivka, Odesa Oblast, Ukraine, 67513
Actively Recruiting
120
Local Institution - 2562
Ternopil, Ternopil Oblast, Ukraine, 460027
Not Yet Recruiting
121
CNPE "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. Acad. O.I. Yushchenko of Vinnytsia Regional Counsil"
Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
Actively Recruiting
122
Local Institution - 2560
Lutsk, Volyn Oblast, Ukraine, 43005
Not Yet Recruiting
123
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)"
Hlevakha, Ukraine, 08631
Actively Recruiting
124
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad RC
Kropyvnytskyi, Ukraine, 25491
Actively Recruiting
125
Local Institution - 2565
Kyiv, Ukraine, 01030
Not Yet Recruiting
126
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
Kyiv, Ukraine, 04080
Actively Recruiting
127
"Medical Centre "Neuroclinic" LLC
Lviv, Ukraine, 79035
Actively Recruiting
128
Local Institution - 2569
Lviv, Ukraine, 79035
Not Yet Recruiting
129
Local Institution - 2568
Odesa, Ukraine, 65006
Not Yet Recruiting
130
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
Poltava, Ukraine, 36013
Actively Recruiting
131
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, United Kingdom, PR2 9HT
Actively Recruiting
132
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey, United Kingdom, KT16 9AU
Actively Recruiting
133
Local Institution - 2502
Cambridge, United Kingdom, CB21 5EF
Not Yet Recruiting
134
South London and Maudsley NHS Foundation Trust
London, United Kingdom, SE5 8AZ
Actively Recruiting
135
Local Institution - 2500
London, United Kingdom, W12 0NN
Not Yet Recruiting
136
NeuroClin Glasgow
Motherwell, United Kingdom, ML1 4UF
Actively Recruiting
137
Cornwall Partnership NHS Foundation Trust
Redruth, United Kingdom, TR15 3QE
Actively Recruiting
138
Sheffield Health and Social care NHS Foundation Trust
Sheffield, United Kingdom, S5 7JT
Actively Recruiting
139
Local Institution - 2509
Stafford, United Kingdom, ST16 3SR
Withdrawn
140
Local Institution - 2503
Wolverhampton, United Kingdom, WV4 5HN
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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