Actively Recruiting
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-1)
Led by Bristol-Myers Squibb · Updated on 2026-04-30
352
Participants Needed
157
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 55 to 90 years
- Diagnosed with Alzheimer's disease confirmed by approved biomarkers or imaging
- Mini-Mental State Examination score between 5 and 22 at screening
- Have a caregiver with at least 10 hours weekly contact willing to support study participation
- History of agitation meeting International Psychogeriatric Association criteria lasting at least two weeks before screening
- NPI/NPI-NH Agitation/Aggression score of 4 or higher at screening and baseline
- Clinical Global Impression-Severity score of 4 or higher related to agitation at screening and baseline
- At least one of the following on the CMAI-IPA at screening and baseline: i) one or more aggressive behaviors several times per week, ii) two or more aggressive behaviors once or twice per week, or iii) three or more aggressive behaviors less than once per week
You will not qualify if you...
- Agitation caused primarily by a condition 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 investigator
- Recent use of monoamine oxidase inhibitors, certain anticonvulsants, mood stabilizers, tricyclic antidepressants, or other psychoactive medications except as-needed anxiolytics
- Use of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors not stable for at least 8 weeks before screening
- Use of mirtazapine or trazodone as hypnotics started less than 8 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 157 locations
1
Imaging Endpoints
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Advanced Research Center (ARC) - Anaheim
Anaheim, California, United States, 92805
Actively Recruiting
3
Kaizen Brain Center
La Jolla, California, United States, 92037
Actively Recruiting
4
The Neurology Group
Pomona, California, United States, 91767
Actively Recruiting
5
Torrance Clinical Research
Torrance, California, United States, 90505
Actively Recruiting
6
Sunwise Clinical Research
Walnut Creek, California, United States, 94596
Actively Recruiting
7
Local Institution - 1630
Colorado Springs, Colorado, United States, 80907
Withdrawn
8
Local Institution - 1622
Maitland, Florida, United States, 32751
Not Yet Recruiting
9
Local Institution - 1631
Maitland, Florida, United States, 32751
Not Yet Recruiting
10
Local Institution - 1602
Miami, Florida, United States, 33122
Not Yet Recruiting
11
Local Institution - 1618
Miami, Florida, United States, 33135
Not Yet Recruiting
12
Hope Research Network - Miami
Miami, Florida, United States, 33166
Actively Recruiting
13
Local Institution - 1604
Miami, Florida, United States, 33186
Active, Not Recruiting
14
Local Institution - 1608
Ocala, Florida, United States, 34471
Not Yet Recruiting
15
Combined Research Orlando (CRO)
Orlando, Florida, United States, 32807
Actively Recruiting
16
Progressive Medical Research
Port Orange, Florida, United States, 32127
Actively Recruiting
17
Local Institution - 1661
Savannah, Georgia, United States, 31406
Not Yet Recruiting
18
Local Institution - 1655
Marrero, Louisiana, United States, 70072
Not Yet Recruiting
19
CBH Health
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
20
Local Institution - 1663
Foxborough, Massachusetts, United States, 02035-1309
Not Yet Recruiting
21
Boston Center for Memory
Newton, Massachusetts, United States, 02459
Actively Recruiting
22
Mayflower Clinical Research
South Dartmouth, Massachusetts, United States, 02747
Actively Recruiting
23
Elixia MA
Springfield, Massachusetts, United States, 01103
Actively Recruiting
24
Local Institution - 1665
Bloomfield Hills, Michigan, United States, 48302
Not Yet Recruiting
25
Oakland Medical Research
Troy, Michigan, United States, 48085
Actively Recruiting
26
Redbird Research
Las Vegas, Nevada, United States, 89119
Actively Recruiting
27
Patient First MD
Middletown, New Jersey, United States, 07748
Actively Recruiting
28
Local Institution - 1664
Princeton, New Jersey, United States, 08540
Not Yet Recruiting
29
Local Institution - 1610
Inwood, New York, United States, 11096
Not Yet Recruiting
30
Mid Hudson Medical Research
New Windsor, New York, United States, 12553
Actively Recruiting
31
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York, United States, 11598-1739
Actively Recruiting
32
Local Institution - 1645
Woodmere, New York, United States, 11598-1739
Withdrawn
33
Local Institution - 1659
Centerville, Ohio, United States, 45459
Not Yet Recruiting
34
Central States Research
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
35
Local Institution - 1652
Columbia, South Carolina, United States, 29205
Withdrawn
36
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas, United States, 79912
Actively Recruiting
37
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States, 84107
Actively Recruiting
38
The Memory Clinic
Bennington, Vermont, United States, 05201-9810
Actively Recruiting
39
Local Institution - 1644
Seattle, Washington, United States, 98122
Not Yet Recruiting
40
Kingfisher Cooperative
Spokane, Washington, United States, 99201
Actively Recruiting
41
Local Institution - 1001
La Plata, Buenos Aires, Argentina, 1900
Not Yet Recruiting
42
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina, B7602CBM
Not Yet Recruiting
43
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina, S2000DEJ
Actively Recruiting
44
Local Institution - 1003
Buenos Aires, Argentina, C1428AQK
Not Yet Recruiting
45
Local Institution - 1004
Córdoba, Argentina, 5000
Not Yet Recruiting
46
Instituto Privado Kremer
Córdoba, Argentina, 5004
Actively Recruiting
47
Centro Medico Luquez
Córdoba, Argentina, 5006
Actively Recruiting
48
Local Institution - 1051
Brasília, Federal District, Brazil, 70200730
Not Yet Recruiting
49
CECPAR - Centro de Estudos Clínicos do Paraná
Curitiba, Paraná, Brazil, 80030-310
Actively Recruiting
50
PUCTrials
Curitiba, Paraná, Brazil, 80230-130
Actively Recruiting
51
Local Institution - 1058
Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
Not Yet Recruiting
52
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
Actively Recruiting
53
Local Institution - 1057
Campinas, São Paulo, Brazil, 13060-080
Not Yet Recruiting
54
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil, 22270-060
Actively Recruiting
55
CPQuali Pesquisa Clínica
São Paulo, Brazil, 01228-000
Actively Recruiting
56
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, Brazil, 04020-060
Actively Recruiting
57
Medical Center Sveti Naum EOOD
Sofia, Sofia-Grad, Bulgaria, 1113
Actively Recruiting
58
Local Institution - 1104
Sofia, Sofia-Grad, Bulgaria, 1202
Not Yet Recruiting
59
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria, 5800
Actively Recruiting
60
Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova
Razgrad, Bulgaria, 7200
Actively Recruiting
61
Medical Center Mladost
Varna, Bulgaria, 9020
Actively Recruiting
62
Local Institution - 1153
Hamilton, Ontario, Canada, ON L8M 1W9
Not Yet Recruiting
63
Local Institution - 1755
London, Ontario, Canada, N6A 5W9
Withdrawn
64
London Health Sciences Centre-Victoria Campus
London, Ontario, Canada, N6A 5W9
Actively Recruiting
65
Sunnybrook Research Institute
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
66
Centre for Addiction & Mental Health
Toronto, Ontario, Canada, M6J 1H4
Actively Recruiting
67
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, Canada, L1N 5S9
Actively Recruiting
68
Local Institution - 1150
Montreal, Quebec, Canada, H4A 3T2
Not Yet Recruiting
69
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
70
Local Institution - 1810
Beijing, Beijing Municipality, China, 100088
Not Yet Recruiting
71
Local Institution - 1815
Haidian District, Beijing Municipality, China, 100191
Not Yet Recruiting
72
Local Institution - 1813
Chongqing, Chongqing Municipality, China, 630014
Not Yet Recruiting
73
Local Institution - 1809
Guangzhou, Guangdong, China, 0
Not Yet Recruiting
74
Shenzhen Kangning Hospital
Shenzhen, Guangdong, China, 518118
Actively Recruiting
75
Local Institution - 1802
Guangzhou, Guangzhou Province, China, 510260
Not Yet Recruiting
76
Local Institution - 1803
Changsha, Hunan, China, 410008
Not Yet Recruiting
77
Local Institution - 1801
Nanjing, Jiangsu, China, 210008
Not Yet Recruiting
78
Local Institution - 1800
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
79
Local Institution - 1816
Xian, Shanxi, China, 710061
Not Yet Recruiting
80
Local Institution - 1819
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
81
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China, 300074
Actively Recruiting
82
Local Institution - 1804
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
83
Local Institution - 1817
Hangzhou, China, 310016
Not Yet Recruiting
84
Local Institution - 1812
Kunming, China, 650032
Not Yet Recruiting
85
Local Institution - 1808
Tianjin, China, 300350
Not Yet Recruiting
86
Local Institution - 1550
Zagreb, City of Zagreb, Croatia, 10000
Not Yet Recruiting
87
Local Institution - 1553
Zagreb, City of Zagreb, Croatia, 10000
Not Yet Recruiting
88
Local Institution - 1554
Rijeka, Croatia, 51000
Not Yet Recruiting
89
Clinical Hospital Center Split
Split, Croatia, HR-21000
Actively Recruiting
90
General Hospital Varazdin
Varaždin, Croatia, 42000
Actively Recruiting
91
University Hospital of Patras
Pátrai, Achaḯa, Greece, 26504
Actively Recruiting
92
Henry Dunant Hospital Center
Athens, Attica, Greece, 115 26
Actively Recruiting
93
Aiginiteio University Hospital
Athens, Attikí, Greece, 115 28
Actively Recruiting
94
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece, 124 62
Actively Recruiting
95
Eginition Hospital
Athens, Greece, 11528
Actively Recruiting
96
Local Institution - 1207
Athens, Greece, 15125
Not Yet Recruiting
97
Local Institution - 1201
Ioannina, Greece, 45500
Not Yet Recruiting
98
Euromedica General Clinic of Thessaloniki
Thessaloniki, Greece, 54645
Actively Recruiting
99
Local Institution - 1255
Ahmedabad, Gujarat, India, 380060
Not Yet Recruiting
100
Local Institution - 1252
Hyderabad, Telangana, India, 500082
Not Yet Recruiting
101
Local Institution - 1254
Varanasi, Uttar Pradesh, India, 221005
Not Yet Recruiting
102
Local Institution - 1250
Kolkata, West Bengal, India, 700054
Not Yet Recruiting
103
Local Institution - 1256
Delhi, India, 110 095
Not Yet Recruiting
104
Local Institution - 1251
Hyderabad, India, 500034
Not Yet Recruiting
105
Local Institution - 1253
New Delhi, India, 110029
Not Yet Recruiting
106
Local Institution - 1301
Hadano, Kanagawa, Japan, 257-0003
Not Yet Recruiting
107
Teikyo University Mizonokuchi Hospital
Kawasaki, Kanagawa, Japan, 213-8507
Actively Recruiting
108
Local Institution - 1304
Sakai, Osaka, Japan, 590-0018
Not Yet Recruiting
109
National Hospital Organization Hizen Psychiatric Center
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan, 842-0192
Actively Recruiting
110
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan, 847-0031
Actively Recruiting
111
Local Institution - 1305
Bunkyo-ku, Tokyo, Japan, 113-8603
Not Yet Recruiting
112
Kuramitsu Hospital
Fukuoka, Japan, 819-0037
Actively Recruiting
113
Okayama City General Medical Center Okayama City Hospital
Okayama, Japan, 700-8557
Actively Recruiting
114
Local Institution - 1308
Shimotsuke-shi, Tochigi, Japan, 329-0498
Not Yet Recruiting
115
Hospital Universitario de Saltillo
Saltillo, Coahuila, Mexico, 25000
Actively Recruiting
116
Boca Clinical Trials Mexico S.C.
Guadalajara, Jalisco, Mexico, 44600
Actively Recruiting
117
Innovacion y Desarrollo en Ciencias de la Salud
Mexico City, Mexico City, Mexico, 14090
Actively Recruiting
118
Local Institution - 1360
Mexico City, Mexico City, Mexico, 14269
Not Yet Recruiting
119
AVIX Investigacion Clinica
Monterrey, Nuevo León, Mexico, 64623
Actively Recruiting
120
Local Institution - 1350
Monterrey, Nuevo León, Mexico, 66460
Not Yet Recruiting
121
Local Institution - 1361
Mexico City, Mexico, 10200
Not Yet Recruiting
122
Neurociencias PRISMA A.C.
San Luis Potosí City, Mexico, 78216
Actively Recruiting
123
Clinical Research Institute S.C.
Tlalnepantla, Mexico, 54055
Actively Recruiting
124
Local Institution - 1401
Coimbra, Portugal, 3049
Not Yet Recruiting
125
Centro Hospitalar do Alto Ave
Guimarães, Portugal, 4835-044
Actively Recruiting
126
Local Institution - 1404
Lisbon, Portugal, 1649-035
Not Yet Recruiting
127
Unidade Local de Saúde de Matosinhos SA
Senhora da Hora, Portugal, 4464-513
Actively Recruiting
128
Campus Neurologico Senior
Torres Vedras, Portugal, 2560-280
Actively Recruiting
129
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041919
Actively Recruiting
130
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041919
Actively Recruiting
131
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041919
Actively Recruiting
132
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041919
Actively Recruiting
133
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041919
Actively Recruiting
134
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041919
Actively Recruiting
135
Local Institution - 1451
Bucharest, Romania, 010825
Not Yet Recruiting
136
Local Institution - 1459
Bucharest, Romania, 060222
Not Yet Recruiting
137
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
Bucharest, Romania, 40874
Actively Recruiting
138
Local Institution - 1461
Constanța, Romania, 90123
Not Yet Recruiting
139
Institutul de Psihiatrie Socola
Iași, Romania, 700282
Actively Recruiting
140
Local Institution - 1460
Sanpetru /Brasov, Romania, 507190
Not Yet Recruiting
141
Local Institution - 1462
Sibiu, Romania, 550082
Not Yet Recruiting
142
Oroitu CAE
Getxo, Bizkaia, Spain, 48993
Actively Recruiting
143
Hospital General Universitario de Elche
Elche (alicante), Spain, 03203
Actively Recruiting
144
Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain, 28006
Actively Recruiting
145
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
146
Hospital Clinico Universitario Virgen de La Victoria
Málaga, Spain, 29010
Actively Recruiting
147
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
148
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
149
Hospital Victoria Eugenia de Sevilla
Seville, Spain, 41009
Actively Recruiting
150
Hospital Mutua Terrassa
Terrassa, Spain, 8221
Actively Recruiting
151
Hospital Universitario De Rio Hortega
Valladolid, Spain, 47012
Actively Recruiting
152
Hospital Viamed Montecanal
Zaragoza, Spain, 50012
Actively Recruiting
153
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
Actively Recruiting
154
National Cheng Kung University Hospital
Tainan, Taiana, Taiwan, 704
Actively Recruiting
155
National Taiwan University Hospital
Taipei, Taiwan, 100229
Actively Recruiting
156
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
157
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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First line of the email MUST contain NCT # and Site #.
CONTACT
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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