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Clinical Trials in the USA / NCT06976203
Recruiting Phase 3

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

NCT06976203 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2025-07-21
Last updated
2026-09-17

Condition(s) studied

Alzheimer's Disease

Investigational drug(s) / intervention(s)

KarXTKarX-ECPlacebo

KarXT: Specified dose on specified days

KarX-EC: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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

Sex
ALL
Min age
60 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (127)

FacilityCityRegionStatus
Fullerton Neurology and Headache Center Fullerton California Recruiting
Irvine Clinical Research Irvine California Recruiting
Inglewood Clinical Los Angeles California Recruiting
Stanford Neuroscience Health Center Palo Alto California Recruiting
Local Institution - 0069 San Diego California Withdrawn
Research of the Rockies Colorado Springs Colorado Recruiting
Neuropsychiatric Research Center of Southwest Florida Fort Myers Florida Recruiting
Local Institution - 0086 Hallandale Florida Completed
Jacksonville Center for Clinical Research Jacksonville Florida Recruiting
K2 MEDICAL Research THE VILLAGES Lady Lake Florida Recruiting
Intercoastal Medical Group Sarasota Florida Recruiting
USF Health Byrd Alzheimer's Institute Tampa Florida Recruiting
Local Institution - 0129 The Villages Florida Not Yet Recruiting
Alzheimer's Research and Treatment Center Wellington Florida Recruiting
Great Lakes Clinical Trials - Andersonville Chicago Illinois Recruiting
Southern Illinois University School of Medicine Springfield Illinois Recruiting
Josephson Wallack Munshower Neurology, PC Indianapolis Indiana Recruiting
Local Institution - 0080 Watertown Massachusetts Not Yet Recruiting
QUEST Research Institute Farmington Hills Michigan Recruiting
Private Practice - Dr. Ronald Louis Schwartz Hattiesburg Mississippi Recruiting
Local Institution - 0119 Ridgewood New Jersey Withdrawn
The Cognitive and Research Center of New Jersey Springfield New Jersey Recruiting
Advanced Clinical Institute West Long Branch New Jersey Recruiting
Neurological Associates Albany Albany New York Recruiting
Dent Neurosciences Research Center, Inc Amherst New York Recruiting
University at Buffalo - UBMD Neurology Buffalo New York Recruiting
Local Institution - 0078 Lake Success New York Withdrawn
Keystone Clinical Studies Plymouth Meeting Pennsylvania Recruiting
Local Institution - 0081 Dallas Texas Not Yet Recruiting
Central Texas Neurology Consultants, PA Round Rock Texas Recruiting
Local Institution - 0076 Renton Washington Completed
Hospital Italiano de Buenos Aires ABB Buenos Aires F.D. Recruiting
Centro Médico Luquez Córdoba Córdoba Province Recruiting
Local Institution - 0025 Buenos Aires Argentina Not Yet Recruiting
CEN Centro Especializado en Neurociencias Córdoba Argentina Recruiting
Instituto Médico DAMIC Córdoba Argentina Recruiting
Resolution Psychopharmacology Research Institute Mendoza Argentina Recruiting
University of the Sunshine Coast Birtinya Birtinya Queensland Recruiting
Local Institution - 0055 Herston (rbwh Grounds) Queensland Not Yet Recruiting
Griffith University - Gold Coast Campus Southport Queensland Recruiting

+ 87 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06976203 on ClinicalTrials.gov ↗ ← All trials in the USA