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NCT06976203PHASE3Recruiting

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

Bristol-Myers Squibb

Start Date

7/21/2025

Completion Date

2/23/2029

Summary

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

Eligibility Criteria

Age Range: 60 years to 85 years

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.

Interventions

DRUG

KarXT

DRUG

KarX-EC

OTHER

Placebo

Interested in This Trial?

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Conditions

Alzheimer's Disease

Locations

Fullerton Neurology and Headache Center

Fullerton, California 92835

United States

Irvine Clinical Research

Irvine, California 92614

United States

Inglewood Clinical

Los Angeles, California 90056

United States

Stanford Neuroscience Health Center

Palo Alto, California 94304

United States

Local Institution - 0069

San Diego, California 92103

United States

Research of the Rockies

Colorado Springs, Colorado 80919

United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida 33912

United States

Local Institution - 0086

Hallandale, Florida 33009

United States

Jacksonville Center for Clinical Research

Jacksonville, Florida 32216

United States

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida 32159

United States

Intercoastal Medical Group

Sarasota, Florida 34239

United States

USF Health Byrd Alzheimer's Institute

Tampa, Florida 33613

United States

Alzheimer's Research and Treatment Center

Wellington, Florida 33414

United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois 60640

United States

Southern Illinois University School of Medicine

Springfield, Illinois 62702

United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana 46256

United States

Local Institution - 0080

Watertown, Massachusetts 02472

United States

QUEST Research Institute

Farmington Hills, Michigan 48334

United States

Private Practice - Dr. Ronald Louis Schwartz

Hattiesburg, Mississippi 39401

United States

Local Institution - 0119

Ridgewood, New Jersey 07450

United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey 07081

United States

Advanced Clinical Institute

West Long Branch, New Jersey 07764

United States

Neurological Associates Albany

Albany, New York 12208

United States

Dent Neurosciences Research Center, Inc

Amherst, New York 14226

United States

University at Buffalo - UBMD Neurology

Buffalo, New York 14203

United States

Local Institution - 0078

Lake Success, New York 11042

United States

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania 19462

United States

Local Institution - 0081

Dallas, Texas 75231

United States

Central Texas Neurology Consultants, PA

Round Rock, Texas 78681

United States

Rainier Clinical Research Center

Renton, Washington 98057

United States

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D. 1181

Argentina

Centro Médico Luquez

Córdoba, Córdoba Province X5006CBI

Argentina

Local Institution - 0025

Buenos Aires, C1428AQK

Argentina

CEN Centro Especializado en Neurociencias

Córdoba, 5000

Argentina

Instituto Médico DAMIC

Córdoba, X5003DCE

Argentina

Resolution Psychopharmacology Research Institute

Mendoza, 5502

Argentina

University of the Sunshine Coast Birtinya

Birtinya, Queensland 4575

Australia

Local Institution - 0055

Herston (rbwh Grounds), Queensland 4006

Australia

Griffith University - Gold Coast Campus

Southport, Queensland 4222

Australia

Austin Health

Ivanhoe, Victoria 3079

Australia

Local Institution - 0115

Fortaleza, Ceará 60135-237

Brazil

Local Institution - 0101

Maringá, Paraná 87015-180

Brazil

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, 22270-060

Brazil

CPQuali Pesquisa Clínica

São Paulo, 01228-000

Brazil

Terveystalo Oulu

Oulu, North Ostrobothnia 90100

Finland

Clinical Research Services Turku

Turku, Southwest Finland 20520

Finland

CRST Helsinki Oy

Helsinki, Uusimaa 00180

Finland

Terveystalo Ruoholahti

Helsinki, 00180

Finland

Itä-Suomen Yliopisto Kuopio

Kuopio, 70210

Finland

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône 13005

France

Local Institution - 0128

Tours, Centre-Val de Loire 37044 Cedex 8

France

Centre Hospitalier Universitaire Toulouse - Cité de la Santé

Toulouse, Haute-Garonne 31000

France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, Hauts-de-France 59037

France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, Ille-et-Vilaine 35000

France

Local Institution - 0127

Saint-Herblain, Loire-Atlantique 44800

France

Centre Hospitalier Universitaire Régional de Nancy

Nancy, Meurthe-et-Moselle 54035

France

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône 69500

France

Local Institution - 0017

Villefranche-sur-Saône, Rhône 69655

France

Bordeaux University Hospital - Pellegrin

Bordeaux, 33076

France

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

Paris, 75010

France

Hôpital Broca

Paris, 75013

France

Pitie Salpetriere University Hospital

Paris, 75013

France

Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau

Strasbourg, 67091

France

Ludwig-Maximilians-Universität München

Munich, Bavaria 80539

Germany

Universitätsmedizin Göttingen - Georg-August-Universität

Göttingen, Lower Saxony 37075

Germany

Private Practice - Dr. Irma Schöll

Bad Homburg, 61348

Germany

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, 09111

Germany

Universitaetsklinikum Koeln

Cologne, 50937

Germany

Universitaetsklinikum Ulm

Ulm, 89081

Germany

University Hospital of Patras

Pátrai, Achaḯa 26504

Greece

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

Chaïdári, Attikí 124 62

Greece

Hygeia Hospital

Marousi, Attikí 151 23

Greece

Local Institution - 0059

Ioannina, Ioánnina 455 00

Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, 546 36

Greece

University of Naples Federico II

Naples, Campania 80131

Italy

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia

Foggia, 71100

Italy

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

Roma, 00168

Italy

Inage Neurology and Memory Clinic

Inage, Chiba 263-0043

Japan

Local Institution - 0123

Matsudo, Chiba 271-0047

Japan

Imon Yukari Neurology Clinic

Hiroshima, Hiroshima 732-0066

Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken 761-0793

Japan

Local Institution - 0125

Kamakura, Kanagawa 247-8533

Japan

Kokankai Kokan Clinic

Kawasaki, Kanagawa 2100852

Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, Kanagawa 211-8533

Japan

Ina Central Hospital

Ina, Nagano 396-0033

Japan

National Hospital Organization Niigata Hospital

Kashiwazaki, Niigata 945-8585

Japan

Katayama Medical Clinic

Kurashiki, Okayama-ken 710-0813

Japan

Tominaga Clinic

Osaka, Osaka 5560015

Japan

National Hospital Organization Hizen Psychiatric Center

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

Japan

Local Institution - 0037

Wako, Saitama 351-0111

Japan

Wako Hospital

Wako, Saitama 351-0111

Japan

Local Institution - 0107

Kyoto, 616-8255

Japan

Brain Research Center Den Bosch B.V.

's-Hertogenbosch, North Brabant 5223 LA

Netherlands

Brain Research Center

Amsterdam, North Holland 1081 GN

Netherlands

Brain Research Center Zwolle

Zwolle, Overijssel 8025 AZ

Netherlands

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship 32-600

Poland

Penta Hospitals Przychodnie, Wrocław Wejherowska

Wroclaw, Lower Silesian Voivodeship 54-239

Poland

Local Institution - 0108

Lublin, Lublin Voivodeship 20-064

Poland

EMC Silesia sp. z o.o.

Katowice, Silesian Voivodeship 40-353

Poland

Campus Neurológico Sénior

Torres Vedras, Lisbon District 2560-280

Portugal

Unidade Local de Saude de Matosinhos

Matosinhos Municipality, Porto District 4464-513

Portugal

Hospital de Braga

Braga, 4710-243

Portugal

Unidade Local de Saúde de Coimbra, E.P.E.

Coimbra, 3000 075

Portugal

Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira

Guimarães, 4800-055

Portugal

Centro Hospitalar do Porto - Hospital de Santo António

Porto, 4050-014

Portugal

SCB Research Center

Bayamón, 00961

Puerto Rico

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest 041914

Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest 041914

Romania

Local Institution - 0113

Constanța, Constanța County 900675

Romania

Local Institution - 0042

Bucharest, 0

Romania

Spitalul de Psihiatrie și Neurologie Brașov

Sanpetru /Brasov, 507190

Romania

Fundació ACE

Barcelona, Barcelona [Barcelona] 08028

Spain

Policlinica Gipuzkoa

Donostia / San Sebastian, Basque Country 20014

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitario Doctor Peset

Valencia, Valenciana, Comunitat 46017

Spain

Complejo Hospitalario Ruber Juan Bravo

Madrid, 28006

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

NIHR Manchester Clinical Research Facility

Manchester, England M13 9WL

United Kingdom

The Maudsley Hospital

London, London, City of SE5 8AZ

United Kingdom

Local Institution - 0103

Edinburgh, Midlothian EH4 2XU

United Kingdom

Warneford Hospital

Oxford, Oxfordshire OX3 7JX

United Kingdom

Re:Cognition Health - Birmingham

Birmingham, B16 8LT

United Kingdom

Leeds and York Partnership NHS Foundation Trust

Leeds, LS9 7TF

United Kingdom

Local Institution - 0126

Motherwell, ML1 4UF

United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF

United Kingdom