A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
NCT ID: NCT05511363
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
380 participants
INTERVENTIONAL
2022-08-23
2026-10-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05145413
An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
NCT05304767
An Open-label Study to Assess the Long-term Safety, Tolerability, Effectiveness, and Durability of Effect of KarXT in Patients With DSM-5 Diagnosis of Schizophrenia
NCT05643170
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
NCT01104766
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
NCT07061288
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
KarXT
Xanomeline and Trospium Chloride Capsules
KarXT
KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
Placebo
Placebo Capsules
Placebo
Placebo Capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KarXT
KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID
Placebo
Placebo Capsules
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Can understand the nature of the study and protocol requirements and provide a signed informed consent form before any study assessments are performed. If the subject is deemed not competent to provide consent, the following requirements for consent must be met.
1. The subject's legally acceptable representative or caregiver/study partner, if local regulations allow, must provide informed consent
2. The subject must provide informed assent
3. Meets clinical criteria for possible or probable Alzheimer's Disease
4. Has a Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome. If not available, a non-contrast brain MRI or non-contrast head CT must be done during screening.
5. Living at the same home or residential assisted-living facility for a minimum of six weeks before Screening
6. Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified or proxy caregiver (spends approximately 10 hours/week with the subject) that is willing to:
1. Attend all visits and report on subject's status
2. Oversee subject compliance with medication and study procedures
3. Participate in the study assessments and provide informed consent to participate in the study
7. History of psychotic symptoms (meeting International Psychogeriatric Association \[IPA\] criteria) for at least 2 months prior to Screening.
8. Clinical Global Impressions-Severity (CGI-S) scale with a score ≥4 (moderate) at Screening and Baseline. CGI-S requires the assessor to consider aspects of the psychosis prior to providing a global assessment of severity. These aspects include hallucinations and delusions.
9. Subjects are required to meet at least one of the following criteria at Screening and Baseline:
1. Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR
2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items.
10. Mini-Mental State Examination (MMSE) score of 8 to 22, inclusive, at Screening
11. If the subject is taking a cholinesterase inhibitor and/or memantine, they must have been on a stable dose for 6 weeks prior to Screening and be willing to maintain a stable dose for the duration of the study.
12. Subject is willing and able to visit the clinic in an outpatient setting for the study duration, follow instructions, and comply with the protocol requirements
13. BMI must be within 18 to 40 kg/m2 inclusive
14. Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP), or men whose sexual partners are WOCBP, must be able and willing to use at least 1 highly effective method of contraception during the study and for at least 1 menstrual cycle (e.g., 30 days) after the last dose of IMP or matching placebo. Sperm donation is not allowed for 30 days after the final dose of the IMP or matching placebo.
Exclusion Criteria
2. History of major depressive episode with psychotic features during the 12 months prior to Screening
3. History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results
5. Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<60 mL/min/1.73 m2
6. History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
7. History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope
8. Any of the following:
1. New York Heart Association Class 2 congestive heart failure
2. Grade 2 or greater angina pectoris
3. Sustained ventricular tachycardia
4. Ventricular fibrillation
5. Torsade de pointes
6. Implantable cardiac defibrillator
9. Myocardial infarction within the 6 months prior to Screening
10. Personal or family history of symptoms of long QT syndrome as evaluated by the investigator
11. Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results
12. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator
13. For males only, any one of the following:
1. History of bladder stones
2. History of recurrent urinary tract infections
3. Serum prostate specific antigen (PSA) \> 10 ng/mL at Screening
4. An International Prostate Symptom Score (IPSS) of 5 (almost always) on items 1, 3, 5, or 6
5. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9
14. History of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months
15. Risk of suicidal behavior during the study as determined by clinical assessment and/ or C-SSRS
16. Clinically significant abnormal finding on the physical examination, electrocardiogram, or clinical laboratory results at Screening
17. Urine toxicology screen is positive substances other than cannabis or benzodiazepines (both cannabis and short-or medium-acting benzodiazepines are allowed in limited quantities during the study) unless approval has been given by the Medical Monitor
18. Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (e.g., lamotrigine, divalproex), lithium, tricyclic antidepressants (e.g., imipramine, desipramine), or any other psychoactive medications except for as-needed anxiolytics (e.g., lorazepam, chloral hydrate)
1. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening may be permitted
2. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening. If needed, an extension (up to two weeks) of the Screening Period may be allowed with approval of the Sponsor/Medical Monitor.
19. If, in the opinion of the Investigator and/or Sponsor/Medical Monitor, subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator and/or Sponsor/ Medical Monitor, may compromise the safety of the subject or affect his/her ability to adhere to the protocol visit schedule or fulfill visit requirements
20. Positive test for coronavirus (COVID-19) within 2 weeks before or at Screening; antigen or PCR local testing can be done at the discretion of the Investigator
21. Unable to taper and discontinue a concomitant medication that would preclude participation in the study
22. Prior exposure to KarXT
23. Experienced any significant adverse events due to trospium, including a known hypersensitivity to trospium
24. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the past year
55 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karuna Therapeutics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Local Institution - 1029
Homewood, Alabama, United States
Local Institution - 1044
Phoenix, Arizona, United States
Local Institution - 1033
Encino, California, United States
Local Institution - 1031
Irvine, California, United States
ATP Clinical Research-302 W La Veta Ave
Orange, California, United States
Local Institution - 1043
Pasadena, California, United States
Local Institution - 1047
San Marcos, California, United States
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
Walnut Creek, California, United States
Local Institution - 1014
Colorado Springs, Colorado, United States
Local Institution - 1013
Stamford, Connecticut, United States
Local Institution - 1011
Boca Raton, Florida, United States
Envision Trials LLC
Bonita Springs, Florida, United States
Local Institution - 1015
Bradenton, Florida, United States
Local Institution - 1048
Clermont, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Local Institution - 1045
Doral, Florida, United States
Local Institution - 1046
Hialeah, Florida, United States
Local Institution - 1024
Hialeah, Florida, United States
Local Institution - 1052
Hialeah, Florida, United States
Local Institution - 1049
Homestead, Florida, United States
K2 Medical Research - Maitland
Maitland, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
Local Institution - 1005
Miami, Florida, United States
Floridian Neuroscience Institute-1901 SW 1 St
Miami, Florida, United States
Local Institution - 1010
Miami, Florida, United States
Local Institution - 1143
Miami, Florida, United States
Local Institution - 1009
Miami, Florida, United States
Future Care Solution LLC
Miami, Florida, United States
South Florida Research Phase I-IV, Inc. - Miami
Miami, Florida, United States
Novel Clinical Research Center, LLC.
Miami, Florida, United States
Local Institution - 1111
Miami, Florida, United States
Coral Research Clinic & Coral Diagnostic Center
Miami, Florida, United States
Local Institution - 1042
Miami, Florida, United States
Local Institution - 1032
Miami Lakes, Florida, United States
Local Institution - 1026
Miami Springs, Florida, United States
Local Institution - 1027
Ocala, Florida, United States
Local Institution - 1012
Pensacola, Florida, United States
Local Institution - 1008
St. Petersburg, Florida, United States
Local Institution - 1050
Tampa, Florida, United States
K2 Medical Research - Tampa
Tampa, Florida, United States
Local Institution - 1040
The Villages, Florida, United States
Local Institution - 1037
Chicago, Illinois, United States
Local Institution - 1018
Manhasset, New York, United States
Local Institution - 1030
New York, New York, United States
Local Institution - 1051
New York, New York, United States
Local Institution - 1017
New York, New York, United States
Local Institution - 1002
Staten Island, New York, United States
Local Institution - 1034
Stony Brook, New York, United States
Five Towns Neurology, PC
Woodmere, New York, United States
Local Institution - 1003
Canton, Ohio, United States
Local Institution - 1028
Oklahoma City, Oklahoma, United States
Local Institution - 1016
Oklahoma City, Oklahoma, United States
Local Institution - 1019
Allentown, Pennsylvania, United States
Local Institution - 1035
Charleston, South Carolina, United States
Local Institution - 1038
Franklin, Tennessee, United States
Local Institution - 1022
Flower Mound, Texas, United States
Local Institution - 1036
Frisco, Texas, United States
Clinical Trial Network - 7080 Southwest Fwy
Houston, Texas, United States
Medical Center Sveti Naum EOOD
Sofia, Sofia-Grad, Bulgaria
Local Institution - 4505
Sofia, Sofia-Grad, Bulgaria
Local Institution - 4502
Sofia, Sofia-Grad, Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, , Bulgaria
Local Institution - 4504
Vratsa, , Bulgaria
Local Institution - 4102
Zagreb, City of Zagreb, Croatia
Local Institution - 4103
Zagreb, City of Zagreb, Croatia
Local Institution - 4105
Zagreb, City of Zagreb, Croatia
Klinika za psihijatriju Vrapce
Zagreb, City of Zagreb, Croatia
Psychiatric Clinic Sveti Ivan
Zagreb, City of Zagreb, Croatia
CLINTRIAL s.r.o.
Prague, Praha, Hlavní Mesto, Czechia
Local Institution - 4003
Brno, South Moravian, Czechia
Neuroterapie KH, s.r.o
Kutná Hora, , Czechia
A-SHINE s.r.o.
Pilsen, , Czechia
Clinoxus s.r.o.
Prague, , Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, , Czechia
Local Institution - 2501
Reims, Marne, France
Local Institution - 2502
Dijon, , France
Local Institution - 2503
Rouen, , France
Local Institution - 2401
Böblingen, Baden-Wurttemberg, Germany
Local Institution - 2403
Bayreuth, Bavaria, Germany
Local Institution - 2402
Homburg, Saarland, Germany
Local Institution - 2301
Rome, Lazio, Italy
Local Institution - 2306
Baggiovara, Modena, Italy
Local Institution - 2307
Ponderano (Biella), Piedmont, Italy
Local Institution - 2308
Florence, Tuscany, Italy
Local Institution - 2304
Milan, , Italy
Local Institution - 2305
Monza, , Italy
Local Institution - 2302
Pisa, , Italy
Local Institution - 2303
Roma, , Italy
Local Institution - 2309
Roma, , Italy
University Clinical Center of Serbia - Pasterova 2 - PPDS
Belgrade, Belgrade, Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, , Serbia
Local Institution - 4307
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Special Hospital for Psychiatric Diseases Kovin
Kovin, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
University Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Centre of Vojvodina
Novi Sad, , Serbia
Local Institution - 4311
Vršac, , Serbia
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
Košice, Košice Region, Slovakia
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, , Slovakia
KONZILIUM s.r.o
Dubnica nad Váhom, , Slovakia
EPAMED s.r.o
Košice, , Slovakia
Crystal Comfort, s.r.o.
Vranov nad Topľou, , Slovakia
Local Institution - 4404
Žilina, , Slovakia
Local Institution - 2205
Barcelona, , Spain
Local Institution - 2207
Madrid, , Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, , Spain
Hospital Victoria Eugenia
Seville, , Spain
Hospital Universitario Rio Hortega
Valladolid, , Spain
Hospital Provincial de Zamora
Zamora, , Spain
Hospital Viamed Montecanal
Zaragoza, , Spain
Local Institution - 2103
Swindon, Wiltshire, United Kingdom
Local Institution - 2105
Aberdeen, , United Kingdom
Local Institution - 2104
Motherwell, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
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
Find local site contact details for specific facilities participating in the trial.
Gustavo Alva, Site 1001
Role: primary
Ira Glick, Site 1007
Role: primary
Daniel Mandri, Site 1020
Role: primary
David Billmeier, Site 1023
Role: primary
Brandon Lenox, Site 1039
Role: primary
Emelina Arocha, Site 1021
Role: primary
Emilio Mantero-Atienza, Site 1115
Role: primary
Pilar Trueba, Site 1129
Role: primary
Silvia Silva Duluc, Site 1053
Role: primary
Heber Varela, Site 1006
Role: primary
Jorge Paoli Bruno, Site 1054
Role: primary
Kelley Yokum, Site 1041
Role: primary
David Steiner, Site 1025
Role: primary
Nelson Berrios, Site 1004
Role: primary
Assen Karadaliev, Site 4501
Role: primary
Maria Aleksandrova, Site 4503
Role: primary
Ninoslav Mimica, Site 4101
Role: primary
Igor Filipcic, Site 4104
Role: primary
Zdenek Solle, Site 4002
Role: primary
Slavomír Pietrucha, Site 4001
Role: primary
Lubos Janu, Site 4005
Role: primary
Michaela Klementova, Site 4004
Role: primary
Ladislav Pazdera, Site 4006
Role: primary
Tanja Stojkovic, Site 4302
Role: primary
Vladimir Diligenski, Site 4306
Role: primary
Ranko Raicevic, Site 4304
Role: primary
Aleksandar Eror, Site 4308
Role: primary
Jovanka Petrovic, Site 4305
Role: primary
Mirjana Jovanovic, Site 4310
Role: primary
Dragana Ignjatovic Ristic, Site 4303
Role: primary
Vladimir Janjic, Site 4301
Role: primary
Marija Semnic, Site 4309
Role: primary
Slavka Dubinska, Site 4405
Role: primary
Beata Dupejova, Site 4401
Role: primary
Magdalena Perichtova, Site 4402
Role: primary
Eva Palova, Site 4406
Role: primary
Dagmar Breznoscakova, Site 4403
Role: primary
Angel Montejo Gonzalez, Site 2204
Role: primary
Felix Viñuela Fernandez, Site 2201
Role: primary
Juan Muñoz Sanchez, Site 2203
Role: primary
Manuel Angel Franco Martin, Site 2202
Role: primary
Antonio Oliveros-Cid, Site 2206
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CN012-0026
Identifier Type: OTHER
Identifier Source: secondary_id
KAR-031
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0026
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.