Last updated 14 days ago
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
586 patients around the world
Available in Puerto Rico, Chile, Brazil, Argentina, United States
Bristol-Myers Squibb
11Research sites
586Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 85 Years
All Gender
Medical requirements
- 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. Participants must agree to maintain this stable dose for the study duration.
- 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.Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder. Participants with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion are also excluded.Participants must not have a history of schizophrenia or other chronic psychosis. Participants 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 are also excluded.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.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto Modelo de Neurología Lennox
Recruiting
Instituto Privado Kremer
Recruiting
Clínica Privada Banfield
Recruiting
Sanatorio Privado Prof. Leon S Morra S.A.
Recruiting
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
Recruiting
Biomedica Research Group
Recruiting
Hospital Clínico de la Universidad de Chile - Santiago
Recruiting
Psicomed Estudios Clínicos
Recruiting
Especialidades Médicas LYS - Chile
Recruiting
StudyMINDSET 1
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Alzheimer disease
Requirements
To 85 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06976216
