Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study to Evaluate the Safety and Efficacy of KarXT for Psychosis Associated With Alzheimer's Disease
Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Updated on 2026-05-04
410
Participants Needed
116
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating KarXT for preventing relapse in people with psychosis linked to Alzheimer's Disease. This Phase 3, randomized, double-blind, placebo-controlled study lasts 38 weeks and involves outpatients aged 55 to 90 years. The main goal is to compare how well KarXT works versus placebo in stopping psychosis relapse, while also assessing time to treatment discontinuation, safety, and tolerability. Participants receive either KarXT capsules at varying doses (from 20 mg/2 mg to 66.7 mg/6.67 mg taken three times daily) or placebo capsules. The study is conducted across multiple centers and uses a quadruple masking design to keep participants and researchers unaware of treatment assignments. The treatment phase spans 38 weeks, during which participants visit outpatient clinics regularly. Throughout the study, participants and their caregivers attend visits to monitor symptoms, side effects, and overall health. Assessments include measuring cognitive function with the Mini-Mental State Examination, tracking neuropsychiatric symptoms and caregiver distress, evaluating movement disorders, body weight, vital signs, laboratory tests, ECGs, and suicidal thoughts. Safety is closely observed up to approximately 42 weeks. The main outcome measured is the time from randomization to relapse by week 38.
CONDITIONS
Brief Title
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 55 to 90 years at screening
- Able to understand the study and provide informed consent (or have a legally acceptable representative provide consent)
- Meets clinical criteria for possible or probable Alzheimer's Disease
- Has a brain MRI or CT scan from the past 5 years or will undergo one at screening
- Living at the same location for at least 4 weeks before screening and plans to stay there during the study
- Able to move independently or with assistance and has a caregiver who spends at least 10 hours per week with them
- History of psychotic symptoms for at least 2 months before screening
- Clinical Global Impressions-Severity score of 4 or higher at screening and baseline
- Meets criteria for moderate to severe delusions or hallucinations at screening and baseline
- Mini-Mental State Examination score between 6 and 24 at screening
- Stable dose of cholinesterase inhibitors and/or memantine for 6 weeks if used, willing to maintain dose
- Willing and able to attend outpatient visits and follow study instructions
- Body mass index between 16 and 40 kg/m2
- Women must not be pregnant or breastfeeding and agree to use effective contraception if applicable
You will not qualify if you...
- Psychotic symptoms due to conditions other than Alzheimer's Disease dementia
- Major depressive episode with psychotic features within 12 months before screening
- Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
- Significant or severe medical conditions that could affect safety or study participation
- Severe kidney impairment (eGFR less than 50 mL/min)
- Stroke history within 12 months or evidence of hemorrhagic stroke
- History of cerebral amyloid angiopathy, epilepsy, CNS tumors, unstable thyroid, or unexplained fainting
- Certain heart conditions including congestive heart failure, angina, arrhythmias, or implanted defibrillator
- Heart attack within 6 months before screening
- Personal or family history of long QT syndrome
- HIV, liver diseases, or active hepatic infections
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
- History of bladder stones, recurrent urinary infections, or prostate issues in men
- Gastrointestinal disorders or serious constipation requiring treatment in last 6 months
- Risk of suicidal behavior as assessed clinically
- Abnormal physical exam, ECG, or lab results at screening
- Positive drug test for substances other than cannabis or benzodiazepines without approval
- Use of certain psychiatric medications without washout or stable dosing as specified
- Prior exposure to KarXT or significant adverse reactions to trospium
- Participation in other clinical trials with investigational drugs recently
- Positive COVID-19 test within 2 weeks before or at screening
- Other criteria as determined by investigator or sponsor to affect safety or compliance
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 - Up to 38 weeks
Participants receive KarXT or placebo to evaluate the safety and efficacy in treating psychosis associated with Alzheimer's Disease.
Regular visits during treatment period as per protocol schedule
Duration - Up to 4 weeks after treatment ends
Participants are monitored for safety and any adverse events after treatment completion.
Visits for safety assessments after treatment completion
Trial Site Locations
Total: 116 locations
1
Local Institution - 1029
Homewood, Alabama, United States, 35209-6809
Active, Not Recruiting
2
Local Institution - 1044
Phoenix, Arizona, United States, 85012-2836
Completed
3
Local Institution - 1033
Encino, California, United States, 91436-2201
Completed
4
Local Institution - 1031
Irvine, California, United States, 92612-1246
Withdrawn
5
ATP Clinical Research-302 W La Veta Ave
Orange, California, United States, 92866
Actively Recruiting
6
Local Institution - 1043
Pasadena, California, United States, 91106
Completed
7
Local Institution - 1047
San Marcos, California, United States, 92069-3595
Completed
8
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
Walnut Creek, California, United States, 94596
Actively Recruiting
9
Local Institution - 1014
Colorado Springs, Colorado, United States, 80907-5302
Completed
10
Local Institution - 1013
Stamford, Connecticut, United States, 06905-1206
Completed
11
Local Institution - 1011
Boca Raton, Florida, United States, 33487-2768
Completed
12
Envision Trials LLC
Bonita Springs, Florida, United States, 34134
Actively Recruiting
13
Local Institution - 1015
Bradenton, Florida, United States, 34209-4687
Completed
14
K2 Medical Research - Winter Garden
Clermont, Florida, United States, 34711-5933
Actively Recruiting
15
Arrow Clinical Trials
Daytona Beach, Florida, United States, 32117-5532
Actively Recruiting
16
Local Institution - 1045
Doral, Florida, United States, 33172-2638
Active, Not Recruiting
17
Local Institution - 1046
Hialeah, Florida, United States, 33012-5826
Active, Not Recruiting
18
Local Institution - 1024
Hialeah, Florida, United States, 33012-5884
Withdrawn
19
Local Institution - 1052
Hialeah, Florida, United States, 33012
Active, Not Recruiting
20
Local Institution - 1049
Homestead, Florida, United States, 33032
Active, Not Recruiting
21
K2 Medical Research - Maitland
Maitland, Florida, United States, 32751-5669
Actively Recruiting
22
Local Institution - 1021
Miami, Florida, United States, 33122-1335
Active, Not Recruiting
23
Local Institution - 1005
Miami, Florida, United States, 33125-3724
Completed
24
Local Institution - 1115
Miami, Florida, United States, 33135
Active, Not Recruiting
25
Local Institution - 1010
Miami, Florida, United States, 33137
Completed
26
Local Institution - 1143
Miami, Florida, United States, 33145-2455
Completed
27
Local Institution - 1009
Miami, Florida, United States, 33155-4630
Active, Not Recruiting
28
Local Institution - 1129
Miami, Florida, United States, 33165-3947
Active, Not Recruiting
29
Local Institution - 1053
Miami, Florida, United States, 33166
Active, Not Recruiting
30
Local Institution - 1006
Miami, Florida, United States, 33173-1474
Active, Not Recruiting
31
Local Institution - 1111
Miami, Florida, United States, 33173
Active, Not Recruiting
32
Local Institution - 1054
Miami, Florida, United States, 33186-4643
Active, Not Recruiting
33
Local Institution - 1042
Miami, Florida, United States, 33186-5882
Active, Not Recruiting
34
Local Institution - 1032
Miami Lakes, Florida, United States, 33014-5602
Active, Not Recruiting
35
Local Institution - 1026
Miami Springs, Florida, United States, 33166-5260
Active, Not Recruiting
36
Local Institution - 1027
Ocala, Florida, United States, 34470-6657
Withdrawn
37
Local Institution - 1012
Pensacola, Florida, United States, 32504-8608
Completed
38
Local Institution - 1008
St. Petersburg, Florida, United States, 33713-8844
Active, Not Recruiting
39
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
40
Local Institution - 1041
Tampa, Florida, United States, 33607-4629
Completed
41
Local Institution - 1040
The Villages, Florida, United States, 32159-8986
Withdrawn
42
Local Institution - 1037
Chicago, Illinois, United States, 60623
Completed
43
Local Institution - 1018
Manhasset, New York, United States, 11030-3816
Active, Not Recruiting
44
Local Institution - 1030
New York, New York, United States, 10016
Withdrawn
45
Local Institution - 1051
New York, New York, United States, 10032-3720
Completed
46
Local Institution - 1017
New York, New York, United States, 10032
Completed
47
Local Institution - 1002
Staten Island, New York, United States, 10314-1607
Active, Not Recruiting
48
Local Institution - 1034
Stony Brook, New York, United States, 11794-0001
Completed
49
Five Towns Neurology, PC
Woodmere, New York, United States, 11598-1739
Actively Recruiting
50
Local Institution - 1003
Canton, Ohio, United States, 44718
Withdrawn
51
Local Institution - 1028
Oklahoma City, Oklahoma, United States, 73104-5007
Withdrawn
52
Local Institution - 1016
Oklahoma City, Oklahoma, United States, 73112
Completed
53
Local Institution - 1019
Allentown, Pennsylvania, United States, 18103
Completed
54
Local Institution - 1035
Charleston, South Carolina, United States, 29425-8900
Completed
55
Local Institution - 1038
Franklin, Tennessee, United States, 37067-5922
Completed
56
Local Institution - 1022
Flower Mound, Texas, United States, 75028-2011
Completed
57
Local Institution - 1036
Frisco, Texas, United States, 75034-6262
Completed
58
Clinical Trial Network - 7080 Southwest Fwy
Houston, Texas, United States, 77074-2085
Actively Recruiting
59
Medical Center Sveti Naum EOOD
Sofia, Sofia-Grad, Bulgaria, 1113
Actively Recruiting
60
Local Institution - 4505
Sofia, Sofia-Grad, Bulgaria, 1431
Completed
61
Local Institution - 4502
Sofia, Sofia-Grad, Bulgaria, 1510
Completed
62
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria, 5800
Actively Recruiting
63
Local Institution - 4504
Vratsa, Bulgaria, 3000
Completed
64
Local Institution - 4103
Zagreb, City of Zagreb, Croatia, 10000
Completed
65
Local Institution - 4105
Zagreb, City of Zagreb, Croatia, 10000
Active, Not Recruiting
66
Polyclinic Neuron
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
67
Local Institution - 4101
Zagreb, City of Zagreb, Croatia, 10090
Active, Not Recruiting
68
Psychiatric Clinic Sveti Ivan
Zagreb, City of Zagreb, Croatia, 10090
Actively Recruiting
69
CLINTRIAL s.r.o.
Prague, Praha, Hlavní Mesto, Czechia, 100 00
Actively Recruiting
70
Local Institution - 4003
Brno, South Moravian, Czechia, 628 00
Withdrawn
71
Local Institution - 4001
Kutná Hora, Czechia, 284 01
Completed
72
A-SHINE s.r.o.
Pilsen, Czechia, 301 00
Actively Recruiting
73
Local Institution - 4004
Prague, Czechia, 140 00
Completed
74
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, Czechia, 516 01
Actively Recruiting
75
Local Institution - 2501
Reims, Marne, France, 51100
Active, Not Recruiting
76
Local Institution - 2502
Dijon, France, 21079
Active, Not Recruiting
77
Local Institution - 2503
Rouen, France, 76000
Completed
78
Local Institution - 2401
Böblingen, Baden-Wurttemberg, Germany, 71034
Completed
79
Local Institution - 2403
Bayreuth, Bavaria, Germany, 95445
Withdrawn
80
Local Institution - 2402
Homburg, Saarland, Germany, 66424
Withdrawn
81
Local Institution - 2301
Rome, Lazio, Italy, 00179
Completed
82
Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
Baggiovara, Modena, Italy, 41126
Actively Recruiting
83
Local Institution - 2307
Ponderano (Biella), Piedmont, Italy, 13875
Active, Not Recruiting
84
Local Institution - 2308
Florence, Tuscany, Italy, 50139
Completed
85
Local Institution - 2304
Milan, Italy, 20121
Completed
86
Local Institution - 2305
Monza, Italy, 20900
Completed
87
Local Institution - 2302
Pisa, Italy, 56126
Completed
88
Local Institution - 2303
Roma, Italy, 00168
Active, Not Recruiting
89
Local Institution - 2309
Roma, Italy, 00189
Completed
90
University Clinical Center of Serbia - Pasterova 2 - PPDS
Belgrade, Belgrade, Serbia, 11000
Actively Recruiting
91
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, Serbia, 11000
Actively Recruiting
92
Local Institution - 4307
Belgrade, Serbia, 11000
Completed
93
Military Medical Academy
Belgrade, Serbia, 11000
Actively Recruiting
94
Military Medical Academy
Belgrade, Serbia, 11000
Actively Recruiting
95
Local Institution - 4305
Kovin, Serbia, 26220
Completed
96
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
97
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
98
University Clinical Center Kragujevac
Kragujevac, Serbia, 34000
Actively Recruiting
99
Clinical Centre of Vojvodina
Novi Sad, Serbia, 21000
Actively Recruiting
100
Local Institution - 4311
Vršac, Serbia, 26300
Completed
101
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
Košice, Košice Region, Slovakia, 041 90
Actively Recruiting
102
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, Slovakia, 974 04
Actively Recruiting
103
KONZILIUM s.r.o
Dubnica nad Váhom, Slovakia, 018 41
Actively Recruiting
104
EPAMED s.r.o
Košice, Slovakia, 040 01
Actively Recruiting
105
Crystal Comfort, s.r.o.
Vranov nad Topľou, Slovakia, 093 01
Actively Recruiting
106
Local Institution - 4404
Žilina, Slovakia, 012 07
Withdrawn
107
Local Institution - 2205
Barcelona, Spain, 8028
Completed
108
Local Institution - 2207
Madrid, Spain, 28006
Completed
109
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, Spain, 37007
Actively Recruiting
110
Hospital Victoria Eugenia
Seville, Spain, 41009
Actively Recruiting
111
Hospital Universitario Rio Hortega
Valladolid, Spain, 47012
Actively Recruiting
112
Hospital Provincial de Zamora
Zamora, Spain, 49021
Actively Recruiting
113
Hospital Viamed Montecanal
Zaragoza, Spain, 50012
Actively Recruiting
114
Local Institution - 2103
Swindon, Wiltshire, United Kingdom, SN3 6BW
Withdrawn
115
Local Institution - 2105
Aberdeen, United Kingdom, AB25 2ZL
Withdrawn
116
Local Institution - 2104
Motherwell, United Kingdom, ML1 4UF
Withdrawn
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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