A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

NCT06976203 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CN012-00522025-520747-32U1111-1317-4515
• Study Type: interventional
• Target: 586
• Locations: 17 countries
• Sites: 123

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

KarXT DRUG

Specified dose on specified days

Also known as: BMS-986510

KarXT + KarX-EC

KarX-EC DRUG

Specified dose on specified days

Also known as: BMS-986519

KarXT + KarX-EC

Placebo OTHER

Specified dose on specified days

Placebo

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 could affect safety or interfere with study procedures.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (123)

Fullerton Neurology and Headache Center

Fullerton, California, 92835, United States

RECRUITING

Inglewood Clinical

Inglewood, California, 90301, United States

RECRUITING

Irvine Clinical Research

Irvine, California, 92614, United States

RECRUITING

Local Institution - 0083

Palo Alto, California, 94304, United States

NOT YET RECRUITING

Local Institution - 0069

San Diego, California, 92103, United States

WITHDRAWN

Research of the Rockies

Colorado Springs, Colorado, 80919, United States

RECRUITING

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, 33912, United States

RECRUITING

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, 33009, United States

RECRUITING

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

RECRUITING

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida, 32159, United States

RECRUITING

Intercoastal Medical Group

Sarasota, Florida, 34239, United States

RECRUITING

USF Health Byrd Alzheimer's Institute

Tampa, Florida, 33613, United States

RECRUITING

Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States

RECRUITING

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, 60640, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States

RECRUITING

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, 46256, United States

RECRUITING

Local Institution - 0080

Watertown, Massachusetts, 02472, United States

NOT YET RECRUITING

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

RECRUITING

Private Practice - Dr. Ronald Louis Schwartz

Hattiesburg, Mississippi, 39401, United States

RECRUITING

Local Institution - 0119

Ridgewood, New Jersey, 07450, United States

WITHDRAWN

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, 07081, United States

RECRUITING

Advanced Clinical Institute

West Long Branch, New Jersey, 07764, United States

RECRUITING

Neurological Associates Albany

Albany, New York, 12208, United States

RECRUITING

Dent Neurosciences Research Center, Inc

Amherst, New York, 14226, United States

RECRUITING

University at Buffalo - UBMD Neurology

Buffalo, New York, 14203, United States

RECRUITING

Local Institution - 0078

Lake Success, New York, 11042, United States

WITHDRAWN

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, 19462, United States

RECRUITING

Local Institution - 0081

Dallas, Texas, 75231, United States

NOT YET RECRUITING

Central Texas Neurology Consultants, PA

Round Rock, Texas, 78681, United States

RECRUITING

Rainier Clinical Research Center

Renton, Washington, 98057, United States

RECRUITING

Local Institution - 0029

ABB, Buenos Aires F.D., 1181, Argentina

NOT YET RECRUITING

Centro Médico Luquez

Córdoba, Córdoba Province, X5006CBI, Argentina

RECRUITING

Local Institution - 0025

Buenos Aires, C1428AQK, Argentina

NOT YET RECRUITING

CEN Centro Especializado en Neurociencias

Córdoba, 5000, Argentina

RECRUITING

Local Institution - 0030

Córdoba, X5003DCE, Argentina

NOT YET RECRUITING

Resolution Psychopharmacology Research Institute

Mendoza, 5502, Argentina

RECRUITING

USC Clinical Trials Sunshine Coast

Birtinya, Queensland, 4575, Australia

RECRUITING

Local Institution - 0055

Saint Lucia, Queensland, 4072, Australia

NOT YET RECRUITING

Griffith University - Gold Coast Campus

Southport, Queensland, 4222, Australia

RECRUITING

Austin Health

Ivanhoe, Victoria, 3079, Australia

RECRUITING

Local Institution - 0115

Fortaleza, Ceará, 60135-237, Brazil

NOT YET RECRUITING

Local Institution - 0101

Maringá, Paraná, 87015-180, Brazil

NOT YET RECRUITING

Local Institution - 0099

Rio de Janeiro, 22270-060, Brazil

NOT YET RECRUITING

Local Institution - 0100

São Paulo, 01228-000, Brazil

NOT YET RECRUITING

Terveystalo Oulu

Oulu, North Ostrobothnia, 90100, Finland

RECRUITING

Clinical Research Services Turku

Turku, Southwest Finland, 20520, Finland

RECRUITING

CRST Helsinki Oy

Helsinki, Uusimaa, 00180, Finland

RECRUITING

Terveystalo Ruoholahti

Helsinki, 00180, Finland

RECRUITING

Itä-Suomen Yliopisto Kuopio

Kuopio, 70210, Finland

RECRUITING

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône, 13005, France

RECRUITING

Centre Hospitalier Universitaire Toulouse - Cité de la Santé

Toulouse, Haute-Garonne, 31000, France

RECRUITING

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, Hauts-de-France, 59037, France

RECRUITING

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, 35000, France

RECRUITING

Centre Hospitalier Universitaire Régional de Nancy

Nancy, Meurthe-et-Moselle, 54035, France

RECRUITING

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône, 69500, France

RECRUITING

Local Institution - 0017

Villefranche-sur-Saône, Rhône, 69655, France

WITHDRAWN

Bordeaux University Hospital - Pellegrin

Bordeaux, 33076, France

RECRUITING

Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

Paris, 75010, France

RECRUITING

Hôpital Broca

Paris, 75013, France

RECRUITING

Pitie Salpetriere University Hospital

Paris, 75013, France

RECRUITING

Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau

Strasbourg, 67091, France

RECRUITING

Local Institution - 0004

Munich, Bavaria, 80539, Germany

NOT YET RECRUITING

Universitätsmedizin Göttingen - Georg-August-Universität

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Private Practice - Dr. Irma Schöll

Bad Homburg, 61348, Germany

RECRUITING

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, 09111, Germany

RECRUITING

Universitaetsklinikum Koeln

Cologne, 50937, Germany

RECRUITING

Universitaetsklinikum Ulm

Ulm, 89081, Germany

RECRUITING

University Hospital of Patras

Pátrai, Achaḯa, 26504, Greece

RECRUITING

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attikí, 124 62, Greece

RECRUITING

Hygeia Hospital

Marousi, Attikí, 151 23, Greece

RECRUITING

Local Institution - 0059

Ioannina, Ioánnina, 455 00, Greece

NOT YET RECRUITING

Local Institution - 0110

Thessaloniki, 546 36, Greece

NOT YET RECRUITING

University of Naples Federico II

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia

Foggia, 71100, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, 00168, Italy

RECRUITING

Local Institution - 0121

Inage, Chiba, 263-0043, Japan

NOT YET RECRUITING

Local Institution - 0123

Matsudo, Chiba, 271-0047, Japan

NOT YET RECRUITING

Local Institution - 0124

Higashihiroshima, Hiroshima, 732-0066, Japan

NOT YET RECRUITING

Local Institution - 0120

Kita, Kagawa-ken, 761-0701, Japan

NOT YET RECRUITING

Local Institution - 0125

Kamakura, Kanagawa, 247-8533, Japan

NOT YET RECRUITING

Kokankai Kokan Clinic

Kawasaki, Kanagawa, 2100852, Japan

RECRUITING

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, Kanagawa, 211-8533, Japan

RECRUITING

Local Institution - 0038

Ina, Nagano, 396-0033, Japan

NOT YET RECRUITING

National Hospital Organization Niigata Hospital

Kashiwazaki, Niigata, 945-8585, Japan

RECRUITING

Katayama Medical Clinic

Kurashiki, Okayama-ken, 710-0813, Japan

RECRUITING

Tominaga Clinic

Osaka, Osaka, 5560015, Japan

RECRUITING

National Hospital Organization Hizen Psychiatric Center

Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192, Japan

RECRUITING

Local Institution - 0037

Wako, Saitama, 351-0111, Japan

WITHDRAWN

Wako Hospital

Wako, Saitama, 351-0111, Japan

RECRUITING

Local Institution - 0107

Kyoto, 616-8255, Japan

NOT YET RECRUITING

Brain Research Center Den Bosch B.V.

's-Hertogenbosch, North Brabant, 5223 LA, Netherlands

RECRUITING

Brain Research Center

Amsterdam, North Holland, 1081 GN, Netherlands

RECRUITING

Brain Research Center Zwolle

Zwolle, Overijssel, 8025 AZ, Netherlands

RECRUITING

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

RECRUITING

Penta Hospitals Przychodnie, Wrocław Wejherowska

Wroclaw, Lower Silesian Voivodeship, 54-239, Poland

RECRUITING

Local Institution - 0108

Lublin, Lublin Voivodeship, 20-064, Poland

NOT YET RECRUITING

EMC Silesia sp. z o.o.

Katowice, Silesian Voivodeship, 40-353, Poland

RECRUITING

Campus Neurológico Sénior

Torres Vedras, Lisbon District, 2560-280, Portugal

RECRUITING

Unidade Local de Saude de Matosinhos

Matosinhos Municipality, Porto District, 4464-513, Portugal

RECRUITING

Hospital de Braga

Braga, 4710-243, Portugal

RECRUITING

Local Institution - 0049

Coimbra, 3000 075, Portugal

NOT YET RECRUITING

Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira

Guimarães, 4800-055, Portugal

RECRUITING

Local Institution - 0052

Porto, 4050-014, Portugal

NOT YET RECRUITING

SCB Research Center

Bayamón, 00961, Puerto Rico

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, 041914, Romania

RECRUITING

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, 041914, Romania

RECRUITING

Local Institution - 0113

Constanța, Constanța County, 900675, Romania

NOT YET RECRUITING

Local Institution - 0042

Bucharest, 0, Romania

NOT YET RECRUITING

Local Institution - 0041

Sanpetru /Brasov, 507190, Romania

NOT YET RECRUITING

Fundació ACE

Barcelona, Barcelona [Barcelona], 08028, Spain

RECRUITING

Policlinica Gipuzkoa

Donostia / San Sebastian, Basque Country, 20014, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, Valenciana, Comunitat, 46017, Spain

RECRUITING

Complejo Hospitalario Ruber Juan Bravo

Madrid, 28006, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

NIHR Manchester Clinical Research Facility

Manchester, England, M13 9WL, United Kingdom

RECRUITING

Local Institution - 0111

Kippax, Leeds, LS25 7JN, United Kingdom

NOT YET RECRUITING

The Maudsley Hospital

London, London, City of, SE5 8AZ, United Kingdom

RECRUITING

Local Institution - 0103

Edinburgh, Midlothian, EH4 2XU, United Kingdom

NOT YET RECRUITING

Warneford Hospital

Oxford, Oxfordshire, OX3 7JX, United Kingdom

RECRUITING

Re:Cognition Health - Birmingham

Birmingham, B16 8LT, United Kingdom

RECRUITING

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

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 21, 2025
• Primary Completion (Estimated): September 11, 2028
• Study Completion (Estimated): February 23, 2029
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

DE (6); FR (12); NL (3); BR (4); AU (4); GR (5); FI (5); RO (5); IT (3); PL (4); ES (7); JP (15); GB (7); PR (1); PT (6); AR (6); US (30)