New drug combo aims to boost brain function in Alzheimer's patients

NCT ID NCT06976216

Symptom relief Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This Phase 3 trial is testing whether a combination of two drugs, KarXT and KarX-EC, can improve cognitive impairment in people with mild to moderate Alzheimer's disease. About 586 participants will receive either the drug combo or a placebo. The study measures changes in memory, daily living skills, and overall function over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: KarXT and KarX-EC (drug combination)
What this could lead to: If successful, this could provide a new treatment option to help improve memory and thinking in people with mild to moderate Alzheimer's disease.
What could go wrong: This is an early Phase 3 trial, so results are not yet known. The drug may not work better than placebo, and there could be side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 586 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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. Exclusion Criteria * 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. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

112 sites in 19 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

A-Shine
RECRUITING

Pilsen, Plzeň-město, 301 00, Czechia
AGE Centrum
RECRUITING

Olomouc, Olomouc Region, 779 00, Czechia
ALPHA Recherche Clinique
RECRUITING

Québec, G3K 2P8, Canada
AMC Research, LLC
RECRUITING

Matthews, North Carolina, 28105, United States
Advanced Memory Research Institute of New Jersey
RECRUITING

Toms River, New Jersey, 08755, United States
Aiginiteio University Hospital
RECRUITING

Athens, Attikí, 115 28, Greece
Alzheimer's Research and Treatment Center
RECRUITING

Stuart, Florida, 34996, United States
Anderson Clinical Research
RECRUITING

Redlands, California, 92374, United States
Ascension Alexian Brothers
RECRUITING

Elk Grove Village, Illinois, 60007, United States
Azienda Ospedaliera Spedali Civili di Brescia
RECRUITING

Brescia, 25123, Italy
Boston Center for Memory
RECRUITING

Newton, Massachusetts, 02459, United States
Center for Advanced Research & Education
RECRUITING

Gainesville, Georgia, 30501, United States
Centricity Research Halifax Multispecialty
RECRUITING

Halifax, Nova Scotia, B3S 1N2, Canada
Centrul de Sanatate Mintala
RECRUITING

Bucharest, 040874, Romania
Centrum Medyczne HCP
RECRUITING

Poznan, Greater Poland Voivodeship, 61-485, Poland
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
RECRUITING

Berlin, State of Berlin, 12203, Germany
Charter Research - Lady Lake
RECRUITING

The Villages, Florida, 32162, United States
Chonnam National University Hospital
RECRUITING

Gwangju, Kwangju-Kwangyǒkshi, 61469, South Korea
Clinica Universidad de Navarra
RECRUITING

Pamplona, Navarre, 31008, Spain
Diex Recherche Victoriaville
RECRUITING

Victoriaville, Quebec, G6P 3Z8, Canada
Ewha Womans University Seoul Hospital
RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 07804, South Korea
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING

Milan, Lombardy, 20122, Italy
Fondazione IRCCS San Gerardo dei Tintori
RECRUITING

Monza, Lombardy, 20900, Italy
Fundación Lennox - Instituto Modelo de Neurología
RECRUITING

Córdoba, 5000, Argentina
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
RECRUITING

Buenos Aires, Buenos Aires F.D., 1133, Argentina
Gadolin Research
RECRUITING

Beaumont, Texas, 77702, United States
Georgetown University Medical Center
RECRUITING

Washington D.C., District of Columbia, 20007, United States
Hanyang University Seoul Hospital
RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 04763, South Korea
HealthPartners Neuroscience Center
RECRUITING

Saint Paul, Minnesota, 55130, United States
Healthy Brain Clinic
RECRUITING

Long Beach, California, 90804, United States
Hospital Clinico San Carlos
RECRUITING

Madrid, 28040, Spain
Hospital Clínic de Barcelona
RECRUITING

Barcelona, Catalunya [Cataluña], 08036, Spain
Hospital Universitari General de Catalunya
RECRUITING

Sant Cugat del Vallès, Barcelona [Barcelona], 08915, Spain
Hospital Universitari de Santa Maria
RECRUITING

Lleida, Lleida [Lérida], 25198, Spain
Hospital Victoria Eugenia
RECRUITING

Seville, Andalusia, 41009, Spain
Hospital das Clinicas FMUSP
RECRUITING

São Paulo, 05403-000, Brazil
Instituto De Neurologia Dra. Ivonne Fraga
RECRUITING

San Juan, 00918, Puerto Rico
Instituto Kremer
RECRUITING

Córdoba, X5004AOA, Argentina
Instituto de Neurologia de Curitiba
RECRUITING

Curitiba, Paraná, 81210310, Brazil
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
RECRUITING

Bucharest, 011241, Romania
Institutul de Psihiatrie Socola
RECRUITING

Iași, 700282, Romania
JEM Research Institute
RECRUITING

Atlantis, Florida, 33462, United States
KARA Institute for Neurological Diseases
RECRUITING

Macquarie Park, New South Wales, 2113, Australia
Klinika za psihijatriju "Vrapče"
RECRUITING

Zagreb, 10090, Croatia
Konkuk University Medical Center
RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea
Local Institution - 0004
WITHDRAWN

Abington, Pennsylvania, 19001, United States
Local Institution - 0016
WITHDRAWN

Columbus, Georgia, 31909, United States
Local Institution - 0089
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 7560356, Chile
Local Institution - 0094
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 7500710, Chile
Local Institution - 0168
NOT_YET_RECRUITING

Brasília, Federal District, 70200730, Brazil
Local Institution - 0215
NOT_YET_RECRUITING

Zagreb, City of Zagreb, 10000, Croatia
Local Institution - 0222
ACTIVE_NOT_RECRUITING

Prague, Praha 8, 18600, Czechia
Local Institution - 0230
NOT_YET_RECRUITING

Antofagasta, 1270244, Chile
Local Institution - 0241
NOT_YET_RECRUITING

Santiago, Santiago Metropolitan, 8380420, Chile
Local Institution - 0256
WITHDRAWN

Athens, Attikí, 115 25, Greece
Local Institution - 0259
ACTIVE_NOT_RECRUITING

New York, New York, 10029, United States
Local Institution - 0266
NOT_YET_RECRUITING

Aracaju, Sergipe, 49075-000, Brazil
Local Institution - 0271
NOT_YET_RECRUITING

Buenos Aires, 1280, Argentina
Local Institution - 0275
WITHDRAWN

Hamburg, 20246, Germany
Local Institution - 0277
WITHDRAWN

Bremen, 28325, Germany
Local Institution - 0282
NOT_YET_RECRUITING

Hyderabad, Telangana, 500034, India
Local Institution - 0285
NOT_YET_RECRUITING

Hyderabad, Telangana, 500082, India
Local Institution - 0286
NOT_YET_RECRUITING

Kolkata, West Bengal, 700054, India
Local Institution - 0287
NOT_YET_RECRUITING

Varanasi, Uttar Pradesh, 221005, India
Local Institution - 0288
NOT_YET_RECRUITING

Bengaluru, Karnataka, 560029, India
Local Institution - 0289
NOT_YET_RECRUITING

Toulouse, Haute-Garonne, 31000, France
Local Institution - 0290
NOT_YET_RECRUITING

Rouen, Haute-Normandie, 76031, France
Local Institution - 0291
NOT_YET_RECRUITING

Montpellier, Languedoc-Roussillon, 34295, France
Local Institution - 0293
NOT_YET_RECRUITING

Villeurbanne, Rhône, 69100, France
Local Institution - 0294
NOT_YET_RECRUITING

Dijon, 21079, France
Local Institution - 0295
NOT_YET_RECRUITING

Nice, Alpes-Maritimes, 06100, France
Local Institution - 0296
NOT_YET_RECRUITING

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands
Local Institution - 0297
NOT_YET_RECRUITING

Amsterdam, North Holland, 1081 GN, Netherlands
Local Institution - 0298
NOT_YET_RECRUITING

Zwolle, Overijssel, 8025 AZ, Netherlands
Local Institution - 0299
NOT_YET_RECRUITING

Reims, Marne, 51092, France
Local Institution - 0300
NOT_YET_RECRUITING

Aachen, 52074, Germany
Local Institution - 0301
NOT_YET_RECRUITING

Mannheim, Baden-Wurttemberg, 68159, Germany
Local Institution - 0302
NOT_YET_RECRUITING

Berlin, 12203, Germany
Merritt Island Medical Research, LLC
RECRUITING

Merritt Island, Florida, 32952, United States
MlynowaMed Psychiatric
RECRUITING

Bialystok, Podlaskie Voivodeship, 15-404, Poland
MoCA Research and Innovation Inc.
RECRUITING

Greenfield Park, Quebec, J4V 2J2, Canada
Mountain Neurological Research Center
RECRUITING

Basalt, Colorado, 81621, United States
NDx Clinical Research Inc.
RECRUITING

Dayton, Ohio, 45459, United States
NYU Langone Health
RECRUITING

New York, New York, 10016, United States
Neuro Health Centrum
RECRUITING

Brno, Brno-město, 628 00, Czechia
NeuroCentrix
RECRUITING

Carlton, Victoria, 3053, Australia
Neurodegenerative Disorders Research
RECRUITING

Perth, Western Australia, 6005, Australia
Neurologická Ambulance - Forbeli
RECRUITING

Prague, Praha 6, 160 00, Czechia
Neurology Clinic, P.C.
RECRUITING

Cordova, Tennessee, 38018, United States
Neuropsychiatrie
RECRUITING

Prague, Praha 6, 160 00, Czechia
OCT Research ULC
RECRUITING

Kelowna, British Columbia, V1Y 1Z9, Canada
Ohio State University
RECRUITING

Columbus, Ohio, 43221, United States
Ospedale San Raffaele
RECRUITING

Milan, Lombardy, 20132, Italy
Osrodek Badan Klinicznych CLINSANTE S.C.
RECRUITING

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Ottawa Memory Clinic
RECRUITING

Ottawa, Ontario, K1Z 1G3, Canada
Penta Hospitals Badania Kliniczne - Gdańsk 1
RECRUITING

Gdansk, Pomeranian Voivodeship, 80-546, Poland
Poliklinika Neuron
RECRUITING

Zagreb, City of Zagreb, 10000, Croatia
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

Bucharest, Bucharest, 041914, Romania
Re:Cognition Health - Chicago
RECRUITING

Chicago, Illinois, 60611, United States
Renstar Medical Research
RECRUITING

Ocala, Florida, 34470, United States
Rhode Island Mood & Memory Research Institute
RECRUITING

East Providence, Rhode Island, 02914, United States
Richmond Clinical Trials
RECRUITING

Richmond, British Columbia, V6V 2L1, Canada
SUNY Upstate Medical University
RECRUITING

Syracuse, New York, 13210, United States
Samsung Medical Center
RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Sanatorio Morra S.A.
RECRUITING

Córdoba, 5000, Argentina
Seoul National University Bundang Hospital
RECRUITING

Seongnam, Kyǒnggi-do, 13620, South Korea
Seoul National University Hospital
RECRUITING

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Southern Neurology
RECRUITING

Kogarah, New South Wales, 2217, Australia
St Vincent's Hospital Sydney Limited
RECRUITING

Darlinghurst, 2010, Australia
Summit Headlands
RECRUITING

Portland, Oregon, 97210, United States
TUM Klinikum
RECRUITING

Munich, 81675, Germany
Toronto Memory Program
RECRUITING

Toronto, Ontario, M3B 2S7, Canada
University General Hospital of Alexandroupoli
RECRUITING

Alexandroupoli, Anatolikí Makedonía Kai Thráki, 681 00, Greece
University General Hospital of Larissa
RECRUITING

Larissa, Thessalía, 41110, Greece
Universitätsklinikum Münster - Albert Schweitzer Campus
RECRUITING

Münster, North Rhine-Westphalia, 48149, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
RECRUITING

Mainz, Rhineland-Palatinate, 55131, Germany
VIN-Julie Schwartzbard
RECRUITING

Aventura, Florida, 33180, United States
Vestra Clinics
RECRUITING

Rychnov nad Kněžnou, 516 01, Czechia

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