A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

NCT06976216 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-00512025-520746-30U1111-1317-4462
• Study Type: interventional
• Target: 586
• Locations: 17 countries
• Sites: 106

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Conditions

Alzheimer's Disease

Keywords

Dementia; Cognitive Impairment; Kar-XT; KarX-EC; Mild Alzheimer's Disease; Moderate Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)

  At week 24

• Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)

  At week 24

Secondary Outcomes (13)

• Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)

  At week 24

• Change from baseline in neuro psychiatric inventory (NPI) total score

  At week 24

• Number of participants with adverse events (AEs)

  At week 24

• Number of participants with serious adverse events (SAEs)

  At week 24

• Number of participants with adverse event of special interest (AESIs)

  At week 24

Study Arms (2)

KarXT + KarX-EC

ACTIVE COMPARATOR

Drug: KarXT; Drug: KarX-EC

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

KarX-EC DRUG

Specified dose on specified days

Also known as: BMS-986519

KarXT + KarX-EC

Placebo OTHER

Specified dose on specified days

Placebo

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

KarXT + KarX-EC

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.
• Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
• Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
• Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.

You may not qualify if:

• Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia.
• Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
• Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
• Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (106)

Healthy Brain Clinic

Long Beach, California, 90804, United States

RECRUITING

Anderson Clinical Research

Redlands, California, 92374, United States

RECRUITING

Mountain Neurological Research Center

Basalt, Colorado, 81621, United States

RECRUITING

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

JEM Research Institute

Atlantis, Florida, 33462, United States

RECRUITING

VIN-Julie Schwartzbard

Aventura, Florida, 33180, United States

RECRUITING

Merritt Island Medical Research, LLC

Merritt Island, Florida, 32952, United States

RECRUITING

Renstar Medical Research

Ocala, Florida, 34470, United States

RECRUITING

Alzheimer's Research and Treatment Center

Stuart, Florida, 34997, United States

RECRUITING

Charter Research - Lady Lake

The Villages, Florida, 32162, United States

RECRUITING

Local Institution - 0016

Columbus, Georgia, 31909, United States

WITHDRAWN

Center for Advanced Research & Education

Gainesville, Georgia, 30501, United States

RECRUITING

Re:Cognition Health - Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Ascension Alexian Brothers

Elk Grove Village, Illinois, 60007, United States

RECRUITING

Boston Center for Memory

Newton, Massachusetts, 02459, United States

RECRUITING

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

RECRUITING

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, 08755, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Local Institution - 0259

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

RECRUITING

AMC Research, LLC

Matthews, North Carolina, 28105, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43221, United States

RECRUITING

NDx Clinical Research Inc.

Dayton, Ohio, 45459, United States

RECRUITING

Summit Headlands

Portland, Oregon, 97210, United States

RECRUITING

Local Institution - 0004

Abington, Pennsylvania, 19001, United States

WITHDRAWN

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, 02914, United States

RECRUITING

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

RECRUITING

Gadolin Research

Beaumont, Texas, 77702, United States

RECRUITING

Local Institution - 0001

Buenos Aires, Buenos Aires F.D., 1133, Argentina

NOT YET RECRUITING

Local Institution - 0271

Buenos Aires, 1280, Argentina

NOT YET RECRUITING

Fundación Lennox - Instituto Modelo de Neurología

Córdoba, 5000, Argentina

RECRUITING

Sanatorio Morra S.A.

Córdoba, 5000, Argentina

RECRUITING

Instituto Kremer

Córdoba, X5004AOA, Argentina

RECRUITING

Southern Neurology

Kogarah, New South Wales, 2217, Australia

RECRUITING

KARA Institute for Neurological Diseases

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

NeuroCentrix

Carlton, Victoria, 3053, Australia

RECRUITING

Neurodegenerative Disorders Research

Perth, Western Australia, 6005, Australia

RECRUITING

St Vincent's Hospital Sydney Limited

Darlinghurst, 2010, Australia

RECRUITING

Local Institution - 0168

Brasília, Federal District, 70200730, Brazil

NOT YET RECRUITING

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210310, Brazil

RECRUITING

Local Institution - 0266

Aracaju, Sergipe, 49075-000, Brazil

NOT YET RECRUITING

Hospital das Clinicas FMUSP

São Paulo, 05403-000, Brazil

RECRUITING

OCT Research ULC

Kelowna, British Columbia, V1Y 1Z9, Canada

RECRUITING

Richmond Clinical Trials

Richmond, British Columbia, V6V 2L1, Canada

RECRUITING

Centricity Research Halifax Multispecialty

Halifax, Nova Scotia, B3S 1N2, Canada

RECRUITING

Ottawa Memory Clinic

Ottawa, Ontario, K1Z 1G3, Canada

RECRUITING

Toronto Memory Program

Toronto, Ontario, M3B 2S7, Canada

RECRUITING

MoCA Research and Innovation Inc.

Greenfield Park, Quebec, J4V 2J2, Canada

RECRUITING

Diex Recherche Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

RECRUITING

ALPHA Recherche Clinique

Québec, G3K 2P8, Canada

RECRUITING

Local Institution - 0230

Antofagasta, AN, 1270244, Chile

NOT YET RECRUITING

Local Institution - 0094

Santiago, Santiago Metropolitan, 7500710, Chile

NOT YET RECRUITING

Local Institution - 0089

Santiago, Santiago Metropolitan, 7560356, Chile

NOT YET RECRUITING

Local Institution - 0241

Santiago, Santiago Metropolitan, 8380420, Chile

NOT YET RECRUITING

Local Institution - 0215

Zagreb, City of Zagreb, 10000, Croatia

NOT YET RECRUITING

Poliklinika Neuron

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Klinika za psihijatriju "Vrapče"

Zagreb, 10090, Croatia

RECRUITING

Neuro Health Centrum

Brno, Brno-město, 628 00, Czechia

RECRUITING

AGE Centrum

Olomouc, Olomoucký kraj, 779 00, Czechia

RECRUITING

A-Shine

Pilsen, Plzeň-město, 301 00, Czechia

RECRUITING

Neurologická Ambulance - Forbeli

Prague, Praha 6, 160 00, Czechia

RECRUITING

Neuropsychiatrie

Prague, Praha 6, 160 00, Czechia

RECRUITING

Institut neuropsychiatricke pece (INEP), Praha

Prague, Praha 8, 18600, Czechia

RECRUITING

Vestra Clinics

Rychnov nad Kněžnou, 516 01, Czechia

RECRUITING

Local Institution - 0219

Münster, North Rhine-Westphalia, 48149, Germany

NOT YET RECRUITING

Local Institution - 0276

Mainz, Rhineland-Palatinate, 55131, Germany

NOT YET RECRUITING

Local Institution - 0218

Berlin, 13125, Germany

NOT YET RECRUITING

Local Institution - 0277

Bremen, 28325, Germany

WITHDRAWN

Local Institution - 0275

Hamburg, 20246, Germany

WITHDRAWN

TUM Klinikum

Munich, 81675, Germany

RECRUITING

University General Hospital of Alexandroupoli

Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00, Greece

RECRUITING

Local Institution - 0256

Athens, Attikí, 115 25, Greece

WITHDRAWN

Aiginiteio University Hospital

Athens, Attikí, 115 28, Greece

RECRUITING

Local Institution - 0257

Larissa, Thessalía, 41110, Greece

NOT YET RECRUITING

Local Institution - 0288

Bengaluru, Karnataka, 560029, India

NOT YET RECRUITING

Local Institution - 0282

Hyderabad, Telangana, 500034, India

NOT YET RECRUITING

Local Institution - 0285

Hyderabad, Telangana, 500082, India

NOT YET RECRUITING

Local Institution - 0287

Varanasi, Uttar Pradesh, 221005, India

NOT YET RECRUITING

Local Institution - 0286

Kolkata, West Bengal, 700054, India

NOT YET RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

RECRUITING

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Local Institution - 0248

Monza, Lombardy, 20900, Italy

NOT YET RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Local Institution - 0262

Poznan, Greater Poland Voivodeship, 61-485, Poland

NOT YET RECRUITING

Osrodek Badan Klinicznych CLINSANTE S.C.

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

MlynowaMed Psychiatric

Bialystok, Podlaskie Voivodeship, 15-404, Poland

RECRUITING

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, 80-546, Poland

RECRUITING

Local Institution - 0181

San Juan, 00918, Puerto Rico

NOT YET RECRUITING

Local Institution - 0273

Bucharest, București, 041914, Romania

NOT YET RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, 041914, Romania

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, 041914, Romania

RECRUITING

Institutul Național de Gerontologie și Geriatrie "Ana Aslan"

Bucharest, 011241, Romania

RECRUITING

Local Institution - 0268

Iași, 700282, Romania

NOT YET RECRUITING

Chonnam National University Hospital

Gwangju, Kwangju-Kwangyǒkshi, 61469, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

RECRUITING

Hanyang University Seoul Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 04763, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

RECRUITING

Ewha Womans University Seoul Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 07804, South Korea

RECRUITING

Hospital Victoria Eugenia

Seville, Andalusia, 41009, Spain

RECRUITING

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona [Barcelona], 08915, Spain

RECRUITING

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Hospital Universitari de Santa Maria

Lleida, Lleida [Lérida], 25198, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): September 11, 2028
• Study Completion (Estimated): February 23, 2029
• Last Updated: April 14, 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

PL (4); US (28); ES (6); CR (3); RO (5); CA (8); DE (6); IT (4); KR (7); AU (5); CL (4); PR (1); BR (4); GR (4); AR (5); CZ (7); IN (5)