TrialPath
← Back to searchRecruiting

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

NCT06976203 · Bristol-Myers Squibb
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 2)
About this study
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
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.
Study design
Enrollment target: 586 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-07-21
Estimated completion: 2029-02-23
Last updated: 2026-03-31
Interventions
Drug: KarXTDrug: KarX-ECOther: Placebo
Primary outcomes
  • 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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (123)
Fullerton Neurology and Headache CenterRecruiting
Fullerton, California, United States
Inglewood ClinicalRecruiting
Inglewood, California, United States
Irvine Clinical ResearchRecruiting
Irvine, California, United States
Local Institution - 0083Not Yet Recruiting
Palo Alto, California, United States
Local Institution - 0069Withdrawn
San Diego, California, United States
Research of the RockiesRecruiting
Colorado Springs, Colorado, United States
Neuropsychiatric Research Center of Southwest FloridaRecruiting
Fort Myers, Florida, United States
Velocity Clinical Research, Hallandale BeachRecruiting
Hallandale, Florida, United States
Jacksonville Center for Clinical ResearchRecruiting
Jacksonville, Florida, United States
K2 MEDICAL Research THE VILLAGESRecruiting
Lady Lake, Florida, United States
Intercoastal Medical GroupRecruiting
Sarasota, Florida, United States
USF Health Byrd Alzheimer's InstituteRecruiting
Tampa, Florida, United States
Alzheimer's Research and Treatment CenterRecruiting
Wellington, Florida, United States
Great Lakes Clinical Trials - AndersonvilleRecruiting
Chicago, Illinois, United States
Southern Illinois University School of MedicineRecruiting
Springfield, Illinois, United States
Josephson Wallack Munshower Neurology, PCRecruiting
Indianapolis, Indiana, United States
Local Institution - 0080Not Yet Recruiting
Watertown, Massachusetts, United States
QUEST Research InstituteRecruiting
Farmington Hills, Michigan, United States
Private Practice - Dr. Ronald Louis SchwartzRecruiting
Hattiesburg, Mississippi, United States
Local Institution - 0119Withdrawn
Ridgewood, New Jersey, United States
The Cognitive and Research Center of New JerseyRecruiting
Springfield, New Jersey, United States
Advanced Clinical InstituteRecruiting
West Long Branch, New Jersey, United States
Neurological Associates AlbanyRecruiting
Albany, New York, United States
Dent Neurosciences Research Center, IncRecruiting
Amherst, New York, United States
University at Buffalo - UBMD NeurologyRecruiting
Buffalo, New York, United States
Local Institution - 0078Withdrawn
Lake Success, New York, United States
Keystone Clinical StudiesRecruiting
Plymouth Meeting, Pennsylvania, United States
Local Institution - 0081Not Yet Recruiting
Dallas, Texas, United States
Central Texas Neurology Consultants, PARecruiting
Round Rock, Texas, United States
Rainier Clinical Research CenterRecruiting
Renton, Washington, United States
Local Institution - 0029Not Yet Recruiting
ABB, Buenos Aires F.D., Argentina
Centro Médico LuquezRecruiting
Córdoba, Córdoba Province, Argentina
Local Institution - 0025Not Yet Recruiting
Buenos Aires, Argentina
CEN Centro Especializado en NeurocienciasRecruiting
Córdoba, Argentina
Local Institution - 0030Not Yet Recruiting
Córdoba, Argentina
Resolution Psychopharmacology Research InstituteRecruiting
Mendoza, Argentina
USC Clinical Trials Sunshine CoastRecruiting
Birtinya, Queensland, Australia
Local Institution - 0055Not Yet Recruiting
Saint Lucia, Queensland, Australia
Griffith University - Gold Coast CampusRecruiting
Southport, Queensland, Australia
Austin HealthRecruiting
Ivanhoe, Victoria, Australia
Local Institution - 0115Not Yet Recruiting
Fortaleza, Ceará, Brazil
Local Institution - 0101Not Yet Recruiting
Maringá, Paraná, Brazil
Local Institution - 0099Not Yet Recruiting
Rio de Janeiro, Brazil
Local Institution - 0100Not Yet Recruiting
São Paulo, Brazil
Terveystalo OuluRecruiting
Oulu, North Ostrobothnia, Finland
Clinical Research Services TurkuRecruiting
Turku, Southwest Finland, Finland
CRST Helsinki OyRecruiting
Helsinki, Uusimaa, Finland
Terveystalo RuoholahtiRecruiting
Helsinki, Finland
Itä-Suomen Yliopisto KuopioRecruiting
Kuopio, Finland
Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneRecruiting
Marseille, Bouches-du-Rhône, France
Centre Hospitalier Universitaire Toulouse - Cité de la SantéRecruiting
Toulouse, Haute-Garonne, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger SalengroRecruiting
Lille, Hauts-de-France, France
Centre Hospitalier Universitaire de Rennes - Hôpital PontchaillouRecruiting
Rennes, Ille-et-Vilaine, France
Centre Hospitalier Universitaire Régional de NancyRecruiting
Nancy, Meurthe-et-Moselle, France
Hospices Civils de Lyon - Hôpital Pierre WertheimerRecruiting
Bron, Rhône, France
Local Institution - 0017Withdrawn
Villefranche-sur-Saône, Rhône, France
Bordeaux University Hospital - PellegrinRecruiting
Bordeaux, France
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital LariboisièreRecruiting
Paris, France
Hôpital BrocaRecruiting
Paris, France
Pitie Salpetriere University HospitalRecruiting
Paris, France
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la RobertsauRecruiting
Strasbourg, France
Local Institution - 0004Not Yet Recruiting
Munich, Bavaria, Germany
Universitätsmedizin Göttingen - Georg-August-UniversitätRecruiting
Göttingen, Lower Saxony, Germany
Private Practice - Dr. Irma SchöllRecruiting
Bad Homburg, Germany
Pharmakologisches Studienzentrum ChemnitzRecruiting
Chemnitz, Germany
Universitaetsklinikum KoelnRecruiting
Cologne, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
University Hospital of PatrasRecruiting
Pátrai, Achaḯa, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"Recruiting
Chaïdári, Attikí, Greece
Hygeia HospitalRecruiting
Marousi, Attikí, Greece
Local Institution - 0059Not Yet Recruiting
Ioannina, Ioánnina, Greece
Local Institution - 0110Not Yet Recruiting
Thessaloniki, Greece
University of Naples Federico IIRecruiting
Naples, Campania, Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti di FoggiaRecruiting
Foggia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro CuoreRecruiting
Roma, Italy
Local Institution - 0121Not Yet Recruiting
Inage, Chiba, Japan
Local Institution - 0123Not Yet Recruiting
Matsudo, Chiba, Japan
Local Institution - 0124Not Yet Recruiting
Higashihiroshima, Hiroshima, Japan
Local Institution - 0120Not Yet Recruiting
Kita, Kagawa-ken, Japan
Local Institution - 0125Not Yet Recruiting
Kamakura, Kanagawa, Japan
Kokankai Kokan ClinicRecruiting
Kawasaki, Kanagawa, Japan
Nippon Medical School Musashi Kosugi HospitalRecruiting
Kawasaki, Kanagawa, Japan
Local Institution - 0038Not Yet Recruiting
Ina, Nagano, Japan
National Hospital Organization Niigata HospitalRecruiting
Kashiwazaki, Niigata, Japan
Katayama Medical ClinicRecruiting
Kurashiki, Okayama-ken, Japan
Tominaga ClinicRecruiting
Osaka, Osaka, Japan
National Hospital Organization Hizen Psychiatric CenterRecruiting
Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan
Local Institution - 0037Withdrawn
Wako, Saitama, Japan
Wako HospitalRecruiting
Wako, Saitama, Japan
Local Institution - 0107Not Yet Recruiting
Kyoto, Japan
Brain Research Center Den Bosch B.V.Recruiting
's-Hertogenbosch, North Brabant, Netherlands
Brain Research CenterRecruiting
Amsterdam, North Holland, Netherlands
Brain Research Center ZwolleRecruiting
Zwolle, Overijssel, Netherlands
Instytut Zdrowia Dr Boczarska JedynakRecruiting
Oświęcim, Lesser Poland Voivodeship, Poland
Penta Hospitals Przychodnie, Wrocław WejherowskaRecruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0108Not Yet Recruiting
Lublin, Lublin Voivodeship, Poland
EMC Silesia sp. z o.o.Recruiting
Katowice, Silesian Voivodeship, Poland
Campus Neurológico SéniorRecruiting
Torres Vedras, Lisbon District, Portugal
Unidade Local de Saude de MatosinhosRecruiting
Matosinhos Municipality, Porto District, Portugal
Hospital de BragaRecruiting
Braga, Portugal
Local Institution - 0049Not Yet Recruiting
Coimbra, Portugal
Centro Hospitalar do Alto Ave - Hospital Senhora da OliveiraRecruiting
Guimarães, Portugal
Local Institution - 0052Not Yet Recruiting
Porto, Portugal
SCB Research CenterRecruiting
Bayamón, Puerto Rico
Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting
Bucharest, Bucharest, Romania
Prof. Dr. Alexandru Obregia Psychiatry HospitalRecruiting
Bucharest, Bucharest, Romania
Local Institution - 0113Not Yet Recruiting
Constanța, Constanța County, Romania
Local Institution - 0042Not Yet Recruiting
Bucharest, Romania
Local Institution - 0041Not Yet Recruiting
Sanpetru /Brasov, Romania
Fundació ACERecruiting
Barcelona, Barcelona [Barcelona], Spain
Policlinica GipuzkoaRecruiting
Donostia / San Sebastian, Basque Country, Spain
Hospital Universitario Marqués de ValdecillaRecruiting
Santander, Cantabria, Spain
Hospital Universitario Quironsalud MadridRecruiting
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Doctor PesetRecruiting
Valencia, Valenciana, Comunitat, Spain
Complejo Hospitalario Ruber Juan BravoRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
NIHR Manchester Clinical Research FacilityRecruiting
Manchester, England, United Kingdom
Local Institution - 0111Not Yet Recruiting
Kippax, Leeds, United Kingdom
The Maudsley HospitalRecruiting
London, London, City of, United Kingdom
Local Institution - 0103Not Yet Recruiting
Edinburgh, Midlothian, United Kingdom
Warneford HospitalRecruiting
Oxford, Oxfordshire, United Kingdom
Re:Cognition Health - BirminghamRecruiting
Birmingham, United Kingdom
Sheffield Teaching Hospitals NHS Foundation TrustRecruiting
Sheffield, United Kingdom
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) · TrialPath