Actively Recruiting
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Updated on 2026-05-11
500
Participants Needed
154
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
CONDITIONS
Official Title
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 55 to 90 years at Screening
- Ability to understand the trial and provide informed consent or assent
- Meets clinical criteria for Possible or Probable Alzheimer's Disease
- Has a brain MRI or CT scan within the past 5 years or will have one during Screening
- Has lived at the same home or assisted-living facility for at least 6 weeks before Screening
- Has an identified study partner with daily contact (about 10 hours per week or more)
- History of psychotic symptoms for at least 2 months before Screening
- Clinical Global Impression-Severity (CGI-S) score of 4 or higher at Screening and Baseline
- Neuropsychiatric Inventory-Clinician (NPI-C) Hallucinations and Delusions score of 6 or higher and either moderate to severe delusions or hallucinations at Screening and Baseline
- Mini-Mental State Examination (MMSE) score between 8 and 22 at Screening
You will not qualify if you...
- Psychotic symptoms caused by conditions other than Alzheimer's Disease
- Major depressive episode with psychotic features in the past 12 months
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- Significant medical conditions that may affect safety or study participation
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
- Prior exposure to KarXT
- Hypersensitivity to KarXT ingredients or trospium chloride
- Previous significant adverse events from trospium
- Participation in another clinical study with investigational drugs within 3 months or more than 2 studies in the past 12 months
- Other protocol-specific inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 154 locations
1
Local Institution - 1116
Chandler, Arizona, United States, 85286
Active, Not Recruiting
2
Local Institution - 1044
Phoenix, Arizona, United States, 85012-2836
Active, Not Recruiting
3
Local Institution - 1104
Anaheim, California, United States, 92805-5854
Active, Not Recruiting
4
Local Institution - 1119
Canoga Park, California, United States, 91303-1844
Active, Not Recruiting
5
Local Institution - 1151
Encino, California, United States, 91316
Active, Not Recruiting
6
Local Institution - 1142
Lancaster, California, United States, 93534-2839
Active, Not Recruiting
7
Local Institution - 1117
Los Alamitos, California, United States, 90720-6506
Active, Not Recruiting
8
Local Institution - 1103
Sherman Oaks, California, United States, 91403-2131
Active, Not Recruiting
9
Local Institution - 1007
Walnut Creek, California, United States, 94596
Active, Not Recruiting
10
Local Institution - 1160
Apopka, Florida, United States, 32703-5835
Withdrawn
11
Local Institution - 1156
Clermont, Florida, United States, 34711-5190
Active, Not Recruiting
12
Local Institution - 1138
Cutler Bay, Florida, United States, 33189-1230
Active, Not Recruiting
13
Local Institution - 1162
Delray Beach, Florida, United States, 33445-2581
Active, Not Recruiting
14
Local Institution - 1164
Doral, Florida, United States, 33122-1620
Active, Not Recruiting
15
Local Institution - 1165
Fort Myers, Florida, United States, 33912-4302
Active, Not Recruiting
16
Local Institution - 1155
Hialeah, Florida, United States, 33012-3158
Active, Not Recruiting
17
Local Institution - 1107
Hialeah, Florida, United States, 33012-3618
Active, Not Recruiting
18
Local Institution - 1120
Hialeah, Florida, United States, 33012-4648
Active, Not Recruiting
19
Local Institution - 1140
Hialeah, Florida, United States, 33016-1814
Active, Not Recruiting
20
Local Institution - 0150
Homestead, Florida, United States, 33032-8187
Active, Not Recruiting
21
Local Institution - 1145
Homestead, Florida, United States, 33032-8187
Active, Not Recruiting
22
Local Institution - 1127
Largo, Florida, United States, 33777-1359
Active, Not Recruiting
23
Local Institution - 1039
Maitland, Florida, United States, 32751-5669
Active, Not Recruiting
24
Local Institution - 1146
Maitland, Florida, United States, 32751-6138
Active, Not Recruiting
25
Local Institution - 1159
Miami, Florida, United States, 33032
Active, Not Recruiting
26
Local Institution - 1118
Miami, Florida, United States, 33122-1721
Active, Not Recruiting
27
Local Institution - 1111
Miami, Florida, United States, 33126-5683
Active, Not Recruiting
28
Local Institution - 1108
Miami, Florida, United States, 33133-4231
Active, Not Recruiting
29
Local Institution - 1125
Miami, Florida, United States, 33135-1601
Active, Not Recruiting
30
Local Institution - 1115
Miami, Florida, United States, 33135
Active, Not Recruiting
31
Local Institution - 1143
Miami, Florida, United States, 33145-2455
Active, Not Recruiting
32
Local Institution - 1113
Miami, Florida, United States, 33155-6630
Active, Not Recruiting
33
Local Institution - 1009
Miami, Florida, United States, 33155
Active, Not Recruiting
34
Local Institution - 1129
Miami, Florida, United States, 33165-3947
Active, Not Recruiting
35
Local Institution - 1150
Miami, Florida, United States, 33165
Active, Not Recruiting
36
Local Institution - 1109
Miami, Florida, United States, 33174-2950
Active, Not Recruiting
37
Local Institution - 1158
Miami, Florida, United States, 33175
Active, Not Recruiting
38
Local Institution - 1147
Miami, Florida, United States, 33176-7947
Active, Not Recruiting
39
Local Institution - 1105
Miami, Florida, United States, 33179-2537
Active, Not Recruiting
40
Local Institution - 1157
Miami, Florida, United States, 33184-1412
Active, Not Recruiting
41
Local Institution - 1126
Miami Gardens, Florida, United States, 33056-4000
Active, Not Recruiting
42
Local Institution - 1102
Miami Lakes, Florida, United States, 33014-6435
Active, Not Recruiting
43
Local Institution - 1136
Orlando, Florida, United States, 32806-1041
Active, Not Recruiting
44
Local Institution - 1112
Orlando, Florida, United States, 32807-3555
Active, Not Recruiting
45
Local Institution - 1137
Port Orange, Florida, United States, 32127-2914
Active, Not Recruiting
46
Health Synergy Clinical Research,LLC - Stuart
Stuart, Florida, United States, 34994
Actively Recruiting
47
Local Institution - 1133
Sweetwater, Florida, United States, 33182
Active, Not Recruiting
48
Local Institution - 1041
Tampa, Florida, United States, 33607-4629
Active, Not Recruiting
49
Local Institution - 1124
Tampa, Florida, United States, 33614-2700
Active, Not Recruiting
50
Local Institution - 1123
Tampa, Florida, United States, 33614-2846
Completed
51
Local Institution - 1110
Tampa, Florida, United States, 33629-5837
Active, Not Recruiting
52
Local Institution - 1040
The Villages, Florida, United States, 32159-8986
Withdrawn
53
Local Institution - 1131
Viera, Florida, United States, 32940
Actively Recruiting
54
Local Institution - 1152
Augusta, Georgia, United States, 30912-0020
Withdrawn
55
Local Institution - 1141
Columbus, Georgia, United States, 31909-1693
Withdrawn
56
Local Institution - 1161
Decatur, Georgia, United States, 30030
Active, Not Recruiting
57
Local Institution - 1148
Elgin, Illinois, United States, 60123-9215
Active, Not Recruiting
58
Local Institution - 1114
Marrero, Louisiana, United States, 70072-3083
Active, Not Recruiting
59
Local Institution - 1139
Rochester Hills, Michigan, United States, 48307-2760
Active, Not Recruiting
60
Local Institution - 1132
Flowood, Mississippi, United States, 39232
Active, Not Recruiting
61
Local Institution - 1144
Las Vegas, Nevada, United States, 89106-4145
Withdrawn
62
Local Institution - 1153
New Hyde Park, New York, United States, 11042-2062
Withdrawn
63
Local Institution - 1135
Port Jefferson Station, New York, United States, 11776-3386
Withdrawn
64
Local Institution - 1122
Dayton, Ohio, United States, 45459-4248
Active, Not Recruiting
65
Local Institution - 1149
Malvern, Pennsylvania, United States, 19355-3267
Withdrawn
66
Local Institution - 1106
Cypress, Texas, United States, 77429-6070
Actively Recruiting
67
Local Institution - 1163
Houston, Texas, United States, 77074-2085
Active, Not Recruiting
68
Local Institution - 1154
Katy, Texas, United States, 77450-1759
Active, Not Recruiting
69
Local Institution - 1121
Red Oak, Texas, United States, 75154
Withdrawn
70
Local Institution - 1134
Stafford, Texas, United States, 77477-3929
Active, Not Recruiting
71
Local Institution - 2801
Hasselt, Limburg, Belgium, 3500
Active, Not Recruiting
72
Local Institution - 2802
Leuven, Vlaams Brabant, Belgium, 3000
Active, Not Recruiting
73
Local Institution - 2803
Roeselare, West-Vlaanderen, Belgium, 8800
Active, Not Recruiting
74
Local Institution - 1605
Calgary, Alberta, Canada, T2N 1N4
Withdrawn
75
Local Institution - 1603
Hamilton, Ontario, Canada, ON L8M 1W9
Withdrawn
76
Local Institution - 1602
Toronto, Ontario, Canada, M5B 1W8
Withdrawn
77
Local Institution - 1604
Whitby, Ontario, Canada, L1N 5S9
Withdrawn
78
Local Institution - 1606
Montreal, Quebec, Canada, H4H 1R3
Withdrawn
79
Local Institution - 1601
Verdun, Quebec, Canada, H4H 1R3
Withdrawn
80
Local Institution - 6002
Providencia, Santiago Metropolitan, Chile, 7500000
Actively Recruiting
81
Local Institution - 6003
Antofagasta, Chile, 127-0244
Actively Recruiting
82
Local Institution - 6001
Las Condes, Chile, 7550000
Actively Recruiting
83
Local Institution - 7007
Hefei, Anhui, China, 230022
Active, Not Recruiting
84
Local Institution - 7004
Beijing, Beijing Municipality, China, 100025
Completed
85
Local Institution - 7005
Beijing, Beijing Municipality, China, 100088
Active, Not Recruiting
86
Local Institution - 7015
Chongqing, Chongqing Municipality, China, 400016
Active, Not Recruiting
87
Local Institution - 7008
Guangzhou, Guangdong, China, 0
Active, Not Recruiting
88
Local Institution - 7016
Guangzhou, Guangdong, China, 510120
Active, Not Recruiting
89
Local Institution - 7009
Guangzhou, Guangdong, China, 510260
Active, Not Recruiting
90
Local Institution - 7003
Shenzhen, Guangdong, China, 518118
Active, Not Recruiting
91
Local Institution - 7014
Nanjing, Jiangsu, China, 210009
Withdrawn
92
Local Institution - 7013
Nanjing, Jiangsu, China, 210011
Active, Not Recruiting
93
Local Institution - 7012
Nanchang, Jiangxi, China, 330008
Active, Not Recruiting
94
Local Institution - 7001
Shanghai, Shanghai Municipality, China, 200030
Active, Not Recruiting
95
Local Institution - 7011
Shanghai, Shanghai Municipality, China, 200080
Active, Not Recruiting
96
Local Institution - 7002
Chengdu, Sichuan, China, 610000
Active, Not Recruiting
97
Local Institution - 7019
Tianjin, Tianjin Municipality, China, 300222
Completed
98
Local Institution - 7017
Hangzhou, Zhejiang, China, 310003
Active, Not Recruiting
99
Local Institution - 7010
Hangzhou, Zhejiang, China, 310013
Active, Not Recruiting
100
Local Institution - 7006
Hangzhou, Zhejiang, China, 310014
Active, Not Recruiting
101
Local Institution - 7020
Hangzhou, Zhejiang, China, 310016
Active, Not Recruiting
102
Local Institution - 7018
Wenzhou, Zhejiang, China, 325000
Active, Not Recruiting
103
Local Institution - 4805
Athens, Attica, Greece, 115 21
Active, Not Recruiting
104
Local Institution - 4803
Athens, Attica, Greece, 115 26
Active, Not Recruiting
105
Local Institution - 4802
Chaidari, Athens, Attica, Greece, 124 62
Active, Not Recruiting
106
Local Institution - 4806
Marousi, Attica, Greece, 151 23
Active, Not Recruiting
107
Local Institution - 4801
Heraklion, Greece, 71110
Active, Not Recruiting
108
Local Institution - 4601
Pécs, Baranya, Hungary, 7633
Active, Not Recruiting
109
Local Institution - 4602
Budapest, Hungary, 1083
Active, Not Recruiting
110
Local Institution - 4603
Miskolc, Hungary, 3526
Active, Not Recruiting
111
Local Institution - 1502
Saltillo Centro, Coahuila, Mexico, 25000
Active, Not Recruiting
112
Local Institution - 1504
Zona Urbana Río Tijuana, Estado de Baja California, Mexico, 22010
Withdrawn
113
Local Institution - 1507
Zapopan, Jalisco, Mexico, 45170
Withdrawn
114
Local Institution - 1503
Monterrey, Nuevo León, Mexico, 64460
Active, Not Recruiting
115
Local Institution - 1505
Monterrey, Nuevo León, Mexico, 64620
Active, Not Recruiting
116
Local Institution - 1501
Culiacán, Sinaloa, Mexico, 80020
Active, Not Recruiting
117
Local Institution - 1506
México, Mexico, 03100
Active, Not Recruiting
118
Local Institution - 6102
Miraflores, Lima region, Peru, 15046
Withdrawn
119
Local Institution - 6103
Pueblo Libre, Lima region, Peru, 15084
Active, Not Recruiting
120
Local Institution - 6101
Callao, Peru, Callao 2
Withdrawn
121
Local Institution - 4206
Lublin, Lublin Voivodeship, Poland, 20-064
Active, Not Recruiting
122
Local Institution - 4207
Lodz, Lódzkie, Poland, 90-349
Active, Not Recruiting
123
Local Institution - 4203
Sopot, Pomeranian Voivodeship, Poland, 81-855
Withdrawn
124
Local Institution - 4208
Katowice, Silesian Voivodeship, Poland, 40-156
Active, Not Recruiting
125
Local Institution - 4204
Bydgoszcz, Poland, 85-080
Active, Not Recruiting
126
Local Institution - 4205
Katowice, Poland, 40-282
Active, Not Recruiting
127
Local Institution - 4202
Lodz, Poland, 90-227
Active, Not Recruiting
128
Local Institution - 4209
Siemianowice Śląskie, Poland, 41-100
Withdrawn
129
Local Institution - 4201
Ścinawa, Poland, 59-330
Active, Not Recruiting
130
Local Institution - 7208
Buk-gu, Daegu Gwang'yeogsi, South Korea, 41404
Active, Not Recruiting
131
Local Institution - 7207
Seongnam-si, Gyeonggido, South Korea, 13496
Active, Not Recruiting
132
Local Institution - 7205
Incheon, Incheon Gwang'yeogsi, South Korea, 21565
Active, Not Recruiting
133
Local Institution - 7204
Busan, South Korea, 49201
Withdrawn
134
Local Institution - 7202
Seongnam-si, South Korea, 0
Active, Not Recruiting
135
Local Institution - 7206
Seoul, South Korea, 03080
Active, Not Recruiting
136
Local Institution - 7203
Seoul, South Korea, 07071
Active, Not Recruiting
137
Local Institution - 7201
Seoul, South Korea, 143-729
Active, Not Recruiting
138
Local Institution - 2901
Geneva, Genève (fr), Switzerland, CH-1205
Withdrawn
139
Local Institution - 2902
Lausanne, Vaud (fr), Switzerland, 1011
Withdrawn
140
Local Institution - 4702
Atakum, Samsun, Turkey (Türkiye), 55270
Active, Not Recruiting
141
Local Institution - 4701
Eskişehir, Turkey (Türkiye), 26040
Active, Not Recruiting
142
Local Institution - 4704
Istanbul, Turkey (Türkiye), 34093
Active, Not Recruiting
143
Local Institution - 4705
Izmir, Turkey (Türkiye), 35210
Active, Not Recruiting
144
Local Institution - 4703
Izmir, Turkey (Türkiye), 35575
Active, Not Recruiting
145
Local Institution - 2110
Ilford, Greater London, United Kingdom, IG1 4HP
Withdrawn
146
Local Institution - 2108
Swinton, Greater Manchester, United Kingdom, M27 8FF
Withdrawn
147
Local Institution - 2101
London, Surrey, United Kingdom, SE5 8AZ
Withdrawn
148
Local Institution - 2105
Aberdeen, United Kingdom, AB25 2ZL
Withdrawn
149
Local Institution - 2109
Chertsey, United Kingdom, KT16 9AU
Withdrawn
150
Local Institution - 2112
Edinburgh, United Kingdom, EH4 2XU
Withdrawn
151
Local Institution - 2106
Leeds, United Kingdom, LS7 3JX
Withdrawn
152
Local Institution - 2104
Motherwell, United Kingdom, ML1 4UF
Withdrawn
153
Local Institution - 2111
Preston, United Kingdom, PR2 9HT
Withdrawn
154
Local Institution - 2107
Sheffield, SouthYorkshire, United Kingdom, s5 7JT
Withdrawn
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
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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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