New drug combo aims to tackle Alzheimer's brain fog

NCT ID NCT06976203

Disease control Sponsor: Bristol-Myers Squibb Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests 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 trial measures changes in thinking, daily function, and safety 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 (BMS-986510) and KarX-EC (BMS-986519)
What this could lead to: If successful, this could provide a new treatment option to help slow or improve cognitive decline in people with mild to moderate Alzheimer's disease.
What could go wrong: This is a Phase 3 trial, but it's still experimental. The drugs may not work better than placebo, and side effects are possible. Results may not apply to all Alzheimer's patients.

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 could affect safety or interfere with study procedures. * Other protocol-defined Inclusion/Exclusion criteria apply.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

118 sites in 17 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

AHEPA University General Hospital of Thessaloniki
RECRUITING

Thessaloniki, 546 36, Greece
Advanced Clinical Institute
RECRUITING

West Long Branch, New Jersey, 07764, United States
Alzheimer's Research and Treatment Center
RECRUITING

Wellington, Florida, 33414, United States
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
RECRUITING

Marseille, Bouches-du-Rhône, 13005, France
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
RECRUITING

Paris, 75010, France
Austin Health
RECRUITING

Ivanhoe, Victoria, 3079, Australia
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia
RECRUITING

Foggia, 71100, Italy
Bordeaux University Hospital - Pellegrin
RECRUITING

Bordeaux, 33076, France
Brain Research Center
RECRUITING

Amsterdam, North Holland, 1081 GN, Netherlands
Brain Research Center Den Bosch B.V.
RECRUITING

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands
Brain Research Center Zwolle
RECRUITING

Zwolle, Overijssel, 8025 AZ, Netherlands
CEN Centro Especializado en Neurociencias
RECRUITING

Córdoba, 5000, Argentina
CPQuali Pesquisa Clínica
RECRUITING

São Paulo, 01228-000, Brazil
CRST Helsinki Oy
RECRUITING

Helsinki, Uusimaa, 00180, Finland
Campus Neurológico Sénior
RECRUITING

Torres Vedras, Lisbon District, 2560-280, Portugal
Central Texas Neurology Consultants, PA
RECRUITING

Round Rock, Texas, 78681, United States
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
RECRUITING

Lille, Hauts-de-France, 59037, France
Centre Hospitalier Universitaire Régional de Nancy
RECRUITING

Nancy, Meurthe-et-Moselle, 54035, France
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
RECRUITING

Toulouse, Haute-Garonne, 31000, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
RECRUITING

Rennes, Ille-et-Vilaine, 35000, France
Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
RECRUITING

Guimarães, 4800-055, Portugal
Centro Hospitalar do Porto - Hospital de Santo António
RECRUITING

Porto, 4050-014, Portugal
Centro Médico Luquez
RECRUITING

Córdoba, Córdoba Province, X5006CBI, Argentina
Clinical Research Services Turku
RECRUITING

Turku, Southwest Finland, 20520, Finland
Complejo Hospitalario Ruber Juan Bravo
RECRUITING

Madrid, 28006, Spain
Dent Neurosciences Research Center, Inc
RECRUITING

Amherst, New York, 14226, United States
EMC Silesia sp. z o.o.
RECRUITING

Katowice, Silesian Voivodeship, 40-353, Poland
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
RECRUITING

Roma, 00168, Italy
Fullerton Neurology and Headache Center
RECRUITING

Fullerton, California, 92835, United States
Fundació ACE
RECRUITING

Barcelona, Barcelona [Barcelona], 08028, Spain
Great Lakes Clinical Trials - Andersonville
RECRUITING

Chicago, Illinois, 60640, United States
Griffith University - Gold Coast Campus
RECRUITING

Southport, Queensland, 4222, Australia
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
RECRUITING

Bron, Rhône, 69500, France
Hospital Italiano de Buenos Aires
RECRUITING

ABB, Buenos Aires F.D., 1181, Argentina
Hospital Universitario 12 de Octubre
RECRUITING

Madrid, 28041, Spain
Hospital Universitario Doctor Peset
RECRUITING

Valencia, Valenciana, Comunitat, 46017, Spain
Hospital Universitario Marqués de Valdecilla
RECRUITING

Santander, Cantabria, 39008, Spain
Hospital Universitario Quironsalud Madrid
RECRUITING

Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital de Braga
RECRUITING

Braga, 4710-243, Portugal
Hygeia Hospital
RECRUITING

Marousi, Attikí, 151 23, Greece
Hôpital Broca
RECRUITING

Paris, 75013, France
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
RECRUITING

Saint-Herblain, Loire-Atlantique, 44800, France
Imon Yukari Neurology Clinic
RECRUITING

Hiroshima, Hiroshima, 732-0066, Japan
Ina Central Hospital
RECRUITING

Ina, Nagano, 396-0033, Japan
Inage Neurology and Memory Clinic
RECRUITING

Inage, Chiba, 263-0043, Japan
Inglewood Clinical
RECRUITING

Los Angeles, California, 90056, United States
Instituto Médico DAMIC
RECRUITING

Córdoba, X5003DCE, Argentina
Instytut Zdrowia Dr Boczarska Jedynak
RECRUITING

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland
Intercoastal Medical Group
RECRUITING

Sarasota, Florida, 34239, United States
Irvine Clinical Research
RECRUITING

Irvine, California, 92614, United States
Itä-Suomen Yliopisto Kuopio
RECRUITING

Kuopio, 70210, Finland
Jacksonville Center for Clinical Research
RECRUITING

Jacksonville, Florida, 32216, United States
Josephson Wallack Munshower Neurology, PC
RECRUITING

Indianapolis, Indiana, 46256, United States
K2 MEDICAL Research THE VILLAGES
RECRUITING

Lady Lake, Florida, 32159, United States
Kagawa University Hospital
RECRUITING

Kita-gun, Kagawa-ken, 761-0793, Japan
Katayama Medical Clinic
RECRUITING

Kurashiki, Okayama-ken, 710-0813, Japan
Keystone Clinical Studies
RECRUITING

Plymouth Meeting, Pennsylvania, 19462, United States
Kokankai Kokan Clinic
RECRUITING

Kawasaki, Kanagawa, 2100852, Japan
Leeds and York Partnership NHS Foundation Trust
RECRUITING

Leeds, LS9 7TF, United Kingdom
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
RECRUITING

Strasbourg, 67091, France
Local Institution - 0017
WITHDRAWN

Villefranche-sur-Saône, Rhône, 69655, France
Local Institution - 0025
NOT_YET_RECRUITING

Buenos Aires, C1428AQK, Argentina
Local Institution - 0037
WITHDRAWN

Wako, Saitama, 351-0111, Japan
Local Institution - 0042
WITHDRAWN

Bucharest, 0, Romania
Local Institution - 0055
NOT_YET_RECRUITING

Herston (rbwh Grounds), Queensland, 4006, Australia
Local Institution - 0059
NOT_YET_RECRUITING

Ioannina, Ioánnina, 455 00, Greece
Local Institution - 0069
WITHDRAWN

San Diego, California, 92103, United States
Local Institution - 0076
COMPLETED

Renton, Washington, 98057, United States
Local Institution - 0078
WITHDRAWN

Lake Success, New York, 11042, United States
Local Institution - 0080
NOT_YET_RECRUITING

Watertown, Massachusetts, 02472, United States
Local Institution - 0081
NOT_YET_RECRUITING

Dallas, Texas, 75231, United States
Local Institution - 0086
COMPLETED

Hallandale, Florida, 33009, United States
Local Institution - 0101
NOT_YET_RECRUITING

Maringá, Paraná, 87015-180, Brazil
Local Institution - 0103
NOT_YET_RECRUITING

Edinburgh, Midlothian, EH4 2XU, United Kingdom
Local Institution - 0107
NOT_YET_RECRUITING

Kyoto, 616-8255, Japan
Local Institution - 0108
WITHDRAWN

Lublin, Lublin Voivodeship, 20-064, Poland
Local Institution - 0113
NOT_YET_RECRUITING

Constanța, Constanța County, 900675, Romania
Local Institution - 0115
NOT_YET_RECRUITING

Fortaleza, Ceará, 60135-237, Brazil
Local Institution - 0119
WITHDRAWN

Ridgewood, New Jersey, 07450, United States
Local Institution - 0123
NOT_YET_RECRUITING

Matsudo, Chiba, 271-0047, Japan
Local Institution - 0125
NOT_YET_RECRUITING

Kamakura, Kanagawa, 247-8533, Japan
Local Institution - 0128
NOT_YET_RECRUITING

Tours, Centre-Val de Loire, 37044 Cedex 8, France
Local Institution - 0129
NOT_YET_RECRUITING

The Villages, Florida, 32162, United States
Ludwig-Maximilians-Universität München
RECRUITING

Munich, Bavaria, 80539, Germany
NIHR Manchester Clinical Research Facility
RECRUITING

Manchester, England, M13 9WL, United Kingdom
National Hospital Organization Hizen Psychiatric Center
RECRUITING

Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192, Japan
National Hospital Organization Niigata Hospital
RECRUITING

Kashiwazaki, Niigata, 945-8585, Japan
NeuroClin Glasgow
RECRUITING

Motherwell, ML1 4UF, United Kingdom
Neurological Associates Albany
RECRUITING

Albany, New York, 12208, United States
Neuropsychiatric Research Center of Southwest Florida
RECRUITING

Fort Myers, Florida, 33912, United States
Nippon Medical School Musashi Kosugi Hospital
RECRUITING

Kawasaki, Kanagawa, 211-8533, Japan
Penta Hospitals Przychodnie, Wrocław Wejherowska
RECRUITING

Wroclaw, Lower Silesian Voivodeship, 54-239, Poland
Pharmakologisches Studienzentrum Chemnitz
RECRUITING

Chemnitz, 09111, Germany
Pitie Salpetriere University Hospital
RECRUITING

Paris, 75013, France
Policlinica Gipuzkoa
RECRUITING

Donostia / San Sebastian, Basque Country, 20014, Spain
Private Practice - Dr. Irma Schöll
RECRUITING

Bad Homburg, 61348, Germany
Private Practice - Dr. Ronald Louis Schwartz
RECRUITING

Hattiesburg, Mississippi, 39401, United States
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING

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

Bucharest, Bucharest, 041914, Romania
QUEST Research Institute
RECRUITING

Farmington Hills, Michigan, 48334, United States
Re:Cognition Health - Birmingham
RECRUITING

Birmingham, B16 8LT, United Kingdom
Research of the Rockies
RECRUITING

Colorado Springs, Colorado, 80919, United States
Resolution Psychopharmacology Research Institute
RECRUITING

Mendoza, 5502, Argentina
Ruschel Medicina e Pesquisa Clínica
RECRUITING

Rio de Janeiro, 22270-060, Brazil
SCB Research Center
RECRUITING

Bayamón, 00961, Puerto Rico
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING

Sheffield, S10 2JF, United Kingdom
Southern Illinois University School of Medicine
RECRUITING

Springfield, Illinois, 62702, United States
Spitalul de Psihiatrie și Neurologie Brașov
RECRUITING

Sanpetru /Brasov, 507190, Romania
Stanford Neuroscience Health Center
RECRUITING

Palo Alto, California, 94304, United States
Terveystalo Oulu
RECRUITING

Oulu, North Ostrobothnia, 90100, Finland
Terveystalo Ruoholahti
RECRUITING

Helsinki, 00180, Finland
The Cognitive and Research Center of New Jersey
RECRUITING

Springfield, New Jersey, 07081, United States
The Maudsley Hospital
RECRUITING

London, London, City of, SE5 8AZ, United Kingdom
Tominaga Clinic
RECRUITING

Osaka, Osaka, 5560015, Japan
USF Health Byrd Alzheimer's Institute
RECRUITING

Tampa, Florida, 33613, United States
Unidade Local de Saude de Matosinhos
RECRUITING

Matosinhos Municipality, Porto District, 4464-513, Portugal
Unidade Local de Saúde de Coimbra, E.P.E.
RECRUITING

Coimbra, 3000 075, Portugal
Universitaetsklinikum Koeln
RECRUITING

Cologne, 50937, Germany
Universitaetsklinikum Ulm
RECRUITING

Ulm, 89081, Germany
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
RECRUITING

Chaïdári, Attikí, 124 62, Greece
University Hospital of Patras
RECRUITING

Pátrai, Achaḯa, 26504, Greece
University at Buffalo - UBMD Neurology
RECRUITING

Buffalo, New York, 14203, United States
University of Naples Federico II
RECRUITING

Naples, Campania, 80131, Italy
University of the Sunshine Coast Birtinya
RECRUITING

Birtinya, Queensland, 4575, Australia
Universitätsmedizin Göttingen - Georg-August-Universität
RECRUITING

Göttingen, Lower Saxony, 37075, Germany
Wako Hospital
RECRUITING

Wako, Saitama, 351-0111, Japan
Warneford Hospital
RECRUITING

Oxford, Oxfordshire, OX3 7JX, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.