A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

NCT05511363 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: CN012-0026KAR-0312024-511740-11
• Study Type: interventional
• Target: 410
• Locations: 11 countries
• Sites: 116

Brief Summary

This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. 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 or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.

Conditions

Psychosis Associated With Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Time from randomization to relapse during the 38-week study

  Week 38

Secondary Outcomes (18)

• Time from randomization to first occurrence of treatment discontinuation for any reason or relapse during the 38-week study

  Week 38

• Change in Neuropsychiatric Inventory-Clinician rating scale (NPI-C) Core Caregiver Distress score

  Up to approximately Week 38

• Number of participants with Adverse Events (AEs)

  Up to approximately Week 42

• Number of participants with Treatment Emergent Adverse Events (TEAEs)

  Up to approximately Week 42

• Number of participants with Serious Adverse Events (SAEs)

  Up to approximately Week 42

Study Arms (2)

KarXT

EXPERIMENTAL

Xanomeline and Trospium Chloride Capsules

Drug: KarXT

Placebo

PLACEBO COMPARATOR

Placebo Capsules

Drug: Placebo

Interventions

KarXT DRUG

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

KarXT

Placebo DRUG

Placebo Capsules

Placebo

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is aged 55 to 90 years, inclusive, at Screening
• 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.
• i) The subject's legally acceptable representative must provide informed consent; ii) The subject must provide informed consent.
• Meets clinical criteria for possible or probable Alzheimer's Disease
• 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.
• Living at the same location for a minimum of 4 weeks before Screening, with the intention of living at the same location throughout the study.
• Capable of self-locomotion (alone or with the aid of an assistive device) and have an identified caregiver or study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant (ie, ≥10 hours per week) on a regular basis to reliably provide accurate information regarding the participant's cognitive, behavioral, and functional status, and is willing to:
• i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures; iii) Participate in the study assessments and provide informed consent to participate in the study.
• History of psychotic symptoms (meeting International Psychogeriatric Association \[IPA\] criteria) for at least 2 months prior to Screening.
• 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.
• Subjects are required to meet at least one of the following criteria at Screening and Baseline:
• i) Moderate to severe delusions, defined as Neuropsychiatric Inventory-Clinician (NPI-C): Delusions domain score of ≥2 on two of the eight items OR; ii) Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on two of the seven items.
• Mini-Mental State Examination (MMSE) score of 6 to 24, inclusive, at Screening
• 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.
• 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

You may not qualify if:

• Psychotic symptoms that are primarily attributable to a condition other than the Alzheimer's Disease causing dementia
• History of major depressive episode with psychotic features during the 12 months prior to Screening
• History of a diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder
• 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
• Significant or severe renal impairment based on a screening cutoff for Estimated Glomerular Filtration Rate (eGFR) of \<50 mL/min
• History of ischemic stroke within 12 months prior to Screening or any evidence of hemorrhagic stroke
• History of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, unstable thyroid function, or unexplained syncope
• Any of the following:
• i) New York Heart Association Class 2 congestive heart failure; ii) Grade 2 or greater angina pectoris; iii) Sustained ventricular tachycardia; iv) Ventricular fibrillation; v) Torsade de pointes; vi) Implantable cardiac defibrillator.
• Myocardial infarction within the 6 months prior to Screening
• Personal or family history of symptoms of long QT syndrome as evaluated by the investigator
• Human immunodeficiency virus, cirrhosis, biliary duct abnormalities, active biliary disease, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history or liver function tests results
• History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the investigator
• Participants with any of the following:
• i) History of bladder stones; ii) History of recurrent urinary tract infections; iii) For male participants:

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (116)

Local Institution - 1029

Homewood, Alabama, 35209-6809, United States

ACTIVE NOT RECRUITING

Local Institution - 1044

Phoenix, Arizona, 85012-2836, United States

COMPLETED

Local Institution - 1033

Encino, California, 91436-2201, United States

COMPLETED

Local Institution - 1031

Irvine, California, 92612-1246, United States

WITHDRAWN

ATP Clinical Research-302 W La Veta Ave

Orange, California, 92866, United States

RECRUITING

Local Institution - 1043

Pasadena, California, 91106, United States

COMPLETED

Local Institution - 1047

San Marcos, California, 92069-3595, United States

COMPLETED

Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS

Walnut Creek, California, 94596, United States

RECRUITING

Local Institution - 1014

Colorado Springs, Colorado, 80907-5302, United States

COMPLETED

Local Institution - 1013

Stamford, Connecticut, 06905-1206, United States

COMPLETED

Local Institution - 1011

Boca Raton, Florida, 33487-2768, United States

COMPLETED

Envision Trials LLC

Bonita Springs, Florida, 34134, United States

RECRUITING

Local Institution - 1015

Bradenton, Florida, 34209-4687, United States

COMPLETED

K2 Medical Research - Winter Garden

Clermont, Florida, 34711-5933, United States

RECRUITING

Arrow Clinical Trials

Daytona Beach, Florida, 32117-5532, United States

RECRUITING

Local Institution - 1045

Doral, Florida, 33172-2638, United States

ACTIVE NOT RECRUITING

Local Institution - 1046

Hialeah, Florida, 33012-5826, United States

ACTIVE NOT RECRUITING

Local Institution - 1024

Hialeah, Florida, 33012-5884, United States

WITHDRAWN

Local Institution - 1052

Hialeah, Florida, 33012, United States

ACTIVE NOT RECRUITING

Local Institution - 1049

Homestead, Florida, 33032, United States

ACTIVE NOT RECRUITING

K2 Medical Research - Maitland

Maitland, Florida, 32751-5669, United States

RECRUITING

Local Institution - 1021

Miami, Florida, 33122-1335, United States

ACTIVE NOT RECRUITING

Local Institution - 1005

Miami, Florida, 33125-3724, United States

COMPLETED

Local Institution - 1115

Miami, Florida, 33135, United States

ACTIVE NOT RECRUITING

Local Institution - 1010

Miami, Florida, 33137, United States

COMPLETED

Local Institution - 1143

Miami, Florida, 33145-2455, United States

COMPLETED

Local Institution - 1009

Miami, Florida, 33155-4630, United States

ACTIVE NOT RECRUITING

Local Institution - 1129

Miami, Florida, 33165-3947, United States

ACTIVE NOT RECRUITING

Local Institution - 1053

Miami, Florida, 33166, United States

ACTIVE NOT RECRUITING

Local Institution - 1006

Miami, Florida, 33173-1474, United States

ACTIVE NOT RECRUITING

Local Institution - 1111

Miami, Florida, 33173, United States

ACTIVE NOT RECRUITING

Local Institution - 1054

Miami, Florida, 33186-4643, United States

ACTIVE NOT RECRUITING

Local Institution - 1042

Miami, Florida, 33186-5882, United States

ACTIVE NOT RECRUITING

Local Institution - 1032

Miami Lakes, Florida, 33014-5602, United States

ACTIVE NOT RECRUITING

Local Institution - 1026

Miami Springs, Florida, 33166-5260, United States

ACTIVE NOT RECRUITING

Local Institution - 1027

Ocala, Florida, 34470-6657, United States

WITHDRAWN

Local Institution - 1012

Pensacola, Florida, 32504-8608, United States

COMPLETED

Local Institution - 1008

St. Petersburg, Florida, 33713-8844, United States

ACTIVE NOT RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Local Institution - 1041

Tampa, Florida, 33607-4629, United States

COMPLETED

Local Institution - 1040

The Villages, Florida, 32159-8986, United States

WITHDRAWN

Local Institution - 1037

Chicago, Illinois, 60623, United States

COMPLETED

Local Institution - 1018

Manhasset, New York, 11030-3816, United States

ACTIVE NOT RECRUITING

Local Institution - 1030

New York, New York, 10016, United States

WITHDRAWN

Local Institution - 1051

New York, New York, 10032-3720, United States

COMPLETED

Local Institution - 1017

New York, New York, 10032, United States

COMPLETED

Local Institution - 1002

Staten Island, New York, 10314-1607, United States

ACTIVE NOT RECRUITING

Local Institution - 1034

Stony Brook, New York, 11794-0001, United States

COMPLETED

Five Towns Neurology, PC

Woodmere, New York, 11598-1739, United States

RECRUITING

Local Institution - 1003

Canton, Ohio, 44718, United States

WITHDRAWN

Local Institution - 1028

Oklahoma City, Oklahoma, 73104-5007, United States

WITHDRAWN

Local Institution - 1016

Oklahoma City, Oklahoma, 73112, United States

COMPLETED

Local Institution - 1019

Allentown, Pennsylvania, 18103, United States

COMPLETED

Local Institution - 1035

Charleston, South Carolina, 29425-8900, United States

COMPLETED

Local Institution - 1038

Franklin, Tennessee, 37067-5922, United States

COMPLETED

Local Institution - 1022

Flower Mound, Texas, 75028-2011, United States

COMPLETED

Local Institution - 1036

Frisco, Texas, 75034-6262, United States

COMPLETED

Clinical Trial Network - 7080 Southwest Fwy

Houston, Texas, 77074-2085, United States

RECRUITING

Medical Center Sveti Naum EOOD

Sofia, Sofia-Grad, 1113, Bulgaria

RECRUITING

Local Institution - 4505

Sofia, Sofia-Grad, 1431, Bulgaria

COMPLETED

Local Institution - 4502

Sofia, Sofia-Grad, 1510, Bulgaria

COMPLETED

Medical Center Medconsult Pleven OOD

Pleven, 5800, Bulgaria

RECRUITING

Local Institution - 4504

Vratsa, 3000, Bulgaria

COMPLETED

Local Institution - 4103

Zagreb, City of Zagreb, 10000, Croatia

COMPLETED

Local Institution - 4105

Zagreb, City of Zagreb, 10000, Croatia

ACTIVE NOT RECRUITING

Polyclinic Neuron

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Local Institution - 4101

Zagreb, City of Zagreb, 10090, Croatia

ACTIVE NOT RECRUITING

Psychiatric Clinic Sveti Ivan

Zagreb, City of Zagreb, 10090, Croatia

RECRUITING

CLINTRIAL s.r.o.

Prague, Praha, Hlavní Mesto, 100 00, Czechia

RECRUITING

Local Institution - 4003

Brno, South Moravian, 628 00, Czechia

WITHDRAWN

Local Institution - 4001

Kutná Hora, 284 01, Czechia

COMPLETED

A-SHINE s.r.o.

Pilsen, 301 00, Czechia

RECRUITING

Local Institution - 4004

Prague, 140 00, Czechia

COMPLETED

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, 516 01, Czechia

RECRUITING

Local Institution - 2501

Reims, Marne, 51100, France

ACTIVE NOT RECRUITING

Local Institution - 2502

Dijon, 21079, France

ACTIVE NOT RECRUITING

Local Institution - 2503

Rouen, 76000, France

COMPLETED

Local Institution - 2401

Böblingen, Baden-Wurttemberg, 71034, Germany

COMPLETED

Local Institution - 2403

Bayreuth, Bavaria, 95445, Germany

WITHDRAWN

Local Institution - 2402

Homburg, Saarland, 66424, Germany

WITHDRAWN

Local Institution - 2301

Rome, Lazio, 00179, Italy

COMPLETED

Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

Baggiovara, Modena, 41126, Italy

RECRUITING

Local Institution - 2307

Ponderano (Biella), Piedmont, 13875, Italy

ACTIVE NOT RECRUITING

Local Institution - 2308

Florence, Tuscany, 50139, Italy

COMPLETED

Local Institution - 2304

Milan, 20121, Italy

COMPLETED

Local Institution - 2305

Monza, 20900, Italy

COMPLETED

Local Institution - 2302

Pisa, 56126, Italy

COMPLETED

Local Institution - 2303

Roma, 00168, Italy

ACTIVE NOT RECRUITING

Local Institution - 2309

Roma, 00189, Italy

COMPLETED

University Clinical Center of Serbia - Pasterova 2 - PPDS

Belgrade, Belgrade, 11000, Serbia

RECRUITING

Clinical Hospital Center Dragisa Misovic Dedinje

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 4307

Belgrade, 11000, Serbia

COMPLETED

Military Medical Academy

Belgrade, 11000, Serbia

RECRUITING

Military Medical Academy

Belgrade, 11000, Serbia

RECRUITING

Local Institution - 4305

Kovin, 26220, Serbia

COMPLETED

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

University Clinical Center Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Clinical Centre of Vojvodina

Novi Sad, 21000, Serbia

RECRUITING

Local Institution - 4311

Vršac, 26300, Serbia

COMPLETED

Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43

Košice, Košice Region, 041 90, Slovakia

RECRUITING

MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.

Banská Bystrica, 974 04, Slovakia

RECRUITING

KONZILIUM s.r.o

Dubnica nad Váhom, 018 41, Slovakia

RECRUITING

EPAMED s.r.o

Košice, 040 01, Slovakia

RECRUITING

Crystal Comfort, s.r.o.

Vranov nad Topľou, 093 01, Slovakia

RECRUITING

Local Institution - 4404

Žilina, 012 07, Slovakia

WITHDRAWN

Local Institution - 2205

Barcelona, 8028, Spain

COMPLETED

Local Institution - 2207

Madrid, 28006, Spain

COMPLETED

Complejo Asistencial Universitario de Salamanca - H. Clinico

Salamanca, 37007, Spain

RECRUITING

Hospital Victoria Eugenia

Seville, 41009, Spain

RECRUITING

Hospital Universitario Rio Hortega

Valladolid, 47012, Spain

RECRUITING

Hospital Provincial de Zamora

Zamora, 49021, Spain

RECRUITING

Hospital Viamed Montecanal

Zaragoza, 50012, Spain

RECRUITING

Local Institution - 2103

Swindon, Wiltshire, SN3 6BW, United Kingdom

WITHDRAWN

Local Institution - 2105

Aberdeen, AB25 2ZL, United Kingdom

WITHDRAWN

Local Institution - 2104

Motherwell, ML1 4UF, United Kingdom

WITHDRAWN

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 23, 2022
• Study Start: August 23, 2022
• Primary Completion (Estimated): October 5, 2026
• Study Completion (Estimated): October 5, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (7); BU (5); US (58); IT (9); DE (3); CR (5); CZ (6); FR (3); SL (6); GB (3); SE (11)