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

NCT ID: NCT06976203
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Conditions: Alzheimer's Disease

Overview

ClinicalTrials.gov lists this study as Recruiting.

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)

Enrollment: 586 participants (Estimated).

What is being studied

Drug: KarX-EC
Drug: KarXT
Other: Placebo

Who may be eligible

Ages: 60 Years to 85 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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 locations

126 study locations are listed.

Recruiting site status is explicitly provided for 126 locations; 103 are listed as Recruiting.

Countries: Argentina, Australia, Brazil, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Poland, Portugal, Puerto Rico, Romania, Spain, United Kingdom, United States

Buenos Aires F.D., Argentina: 1
Córdoba Province, Argentina: 1
Queensland, Australia: 3
Victoria, Australia: 1
Ceará, Brazil: 1
Paraná, Brazil: 1
North Ostrobothnia, Finland: 1
Southwest Finland, Finland: 1
Uusimaa, Finland: 1
Bouches-du-Rhône, France: 1
Centre-Val de Loire, France: 1
Haute-Garonne, France: 1
Hauts-de-France, France: 1
Ille-et-Vilaine, France: 1
Loire-Atlantique, France: 1
Meurthe-et-Moselle, France: 1
Rhône, France: 2
Bavaria, Germany: 1
Lower Saxony, Germany: 1
Achaḯa, Greece: 1
Attikí, Greece: 2
Ioánnina, Greece: 1
Campania, Italy: 1
Chiba, Japan: 2
Hiroshima, Japan: 1
Kagawa-ken, Japan: 1
Kanagawa, Japan: 3
Nagano, Japan: 1
Niigata, Japan: 1
Okayama-ken, Japan: 1

Sample of listed locations

Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., 1181, Argentina — Recruiting
Centro Médico Luquez — Córdoba, Córdoba Province, X5006CBI, Argentina — Recruiting
CEN Centro Especializado en Neurociencias — Córdoba, 5000, Argentina — Recruiting
Instituto Médico DAMIC — Córdoba, X5003DCE, Argentina — Recruiting
Resolution Psychopharmacology Research Institute — Mendoza, 5502, Argentina — Recruiting
University of the Sunshine Coast Birtinya — Birtinya, Queensland, 4575, Australia — Recruiting
Griffith University - Gold Coast Campus — Southport, Queensland, 4222, Australia — Recruiting
Austin Health — Ivanhoe, Victoria, 3079, Australia — Recruiting
Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro, 22270-060, Brazil — Recruiting
CPQuali Pesquisa Clínica — São Paulo, 01228-000, Brazil — 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
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes — Saint-Herblain, Loire-Atlantique, 44800, 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
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

Study details

Start date: July 21, 2025
Primary completion date: September 11, 2028
Completion date: February 23, 2029
First posted: May 16, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT06976203
Registry last updated: September 17, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT06976203 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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