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

NCT ID
NCT06976216
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 1)

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 reflect significant pathology other than AD or could affect safety or interfere with study procedures. * Other protocol-defined Inclusion/Exclusion criteria apply.

Study locations

118 study locations are listed.

Recruiting site status is explicitly provided for 118 locations; 87 are listed as Recruiting.

Countries: Argentina, Australia, Brazil, Canada, Chile, Croatia, Czechia, France, Germany, Greece, India, Italy, Netherlands, Poland, Puerto Rico, Romania, South Korea, Spain, United States

  • Buenos Aires F.D., Argentina: 1
  • New South Wales, Australia: 2
  • Victoria, Australia: 1
  • Western Australia, Australia: 1
  • Federal District, Brazil: 1
  • Paraná, Brazil: 1
  • Sergipe, Brazil: 1
  • British Columbia, Canada: 2
  • Nova Scotia, Canada: 1
  • Ontario, Canada: 2
  • Quebec, Canada: 2
  • Santiago Metropolitan, Chile: 3
  • City of Zagreb, Croatia: 2
  • Brno-město, Czechia: 1
  • Olomouc Region, Czechia: 1
  • Plzeň-město, Czechia: 1
  • Praha 6, Czechia: 2
  • Praha 8, Czechia: 1
  • Alpes-Maritimes, France: 1
  • Haute-Garonne, France: 1
  • Haute-Normandie, France: 1
  • Languedoc-Roussillon, France: 1
  • Marne, France: 1
  • Rhône, France: 1
  • Baden-Wurttemberg, Germany: 1
  • North Rhine-Westphalia, Germany: 1
  • Rhineland-Palatinate, Germany: 1
  • State of Berlin, Germany: 1
  • Anatolikí Makedonía Kai Thráki, Greece: 1
  • Attikí, Greece: 2

Sample of listed locations

  • Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) — Buenos Aires, Buenos Aires F.D., 1133, Argentina — Recruiting
  • Fundación Lennox - Instituto Modelo de Neurología — Córdoba, 5000, Argentina — Recruiting
  • Instituto Kremer — Córdoba, X5004AOA, Argentina — Recruiting
  • Sanatorio Morra S.A. — Córdoba, 5000, Argentina — Recruiting
  • Southern Neurology — Kogarah, New South Wales, 2217, Australia — Recruiting
  • KARA Institute for Neurological Diseases — Macquarie Park, New South Wales, 2113, Australia — Recruiting
  • NeuroCentrix — Carlton, Victoria, 3053, Australia — Recruiting
  • Neurodegenerative Disorders Research — Perth, Western Australia, 6005, Australia — Recruiting
  • St Vincent's Hospital Sydney Limited — Darlinghurst, 2010, Australia — Recruiting
  • L2IP - Instituto de Pesquisas Clínicas — Brasília, Federal District, 70200730, Brazil — Recruiting
  • Instituto de Neurologia de Curitiba — Curitiba, Paraná, 81210310, Brazil — Recruiting
  • Hospital das Clinicas FMUSP — São Paulo, 05403-000, Brazil — Recruiting
  • OCT Research ULC — Kelowna, British Columbia, V1Y 1Z9, Canada — Recruiting
  • Richmond Clinical Trials — Richmond, British Columbia, V6V 2L1, Canada — Recruiting
  • Centricity Research Halifax Multispecialty — Halifax, Nova Scotia, B3S 1N2, Canada — Recruiting
  • Ottawa Memory Clinic — Ottawa, Ontario, K1Z 1G3, Canada — Recruiting
  • Toronto Memory Program — Toronto, Ontario, M3B 2S7, Canada — Recruiting
  • MoCA Research and Innovation Inc. — Greenfield Park, Quebec, J4V 2J2, Canada — Recruiting
  • Diex Recherche Victoriaville — Victoriaville, Quebec, G6P 3Z8, Canada — Recruiting
  • ALPHA Recherche Clinique — Québec, G3K 2P8, Canada — Recruiting
  • Especialidades Médicas LYS — Santiago, Santiago Metropolitan, 7560356, Chile — Recruiting
  • Poliklinika Neuron — Zagreb, City of Zagreb, 10000, Croatia — Recruiting
  • Klinika za psihijatriju "Vrapče" — Zagreb, 10090, Croatia — Recruiting
  • Neuro Health Centrum — Brno, Brno-město, 628 00, Czechia — Recruiting
  • AGE Centrum — Olomouc, Olomouc Region, 779 00, Czechia — Recruiting

Study details

Start date
July 14, 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
NCT06976216
Registry last updated
October 6, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT06976216 on ClinicalTrials.gov

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