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Clinical Trials in the USA / NCT06976216
Recruiting Phase 3

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

NCT06976216 · tracked via the Priya Life Science USA tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 3
Started
2025-07-14
Last updated
2026-08-20

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

Primary outcome measure(s)

Trial sites (119)

FacilityCityRegionStatus
Healthy Brain Clinic Long Beach California Recruiting
Anderson Clinical Research Redlands California Recruiting
Mountain Neurological Research Center Basalt Colorado Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
JEM Research Institute Atlantis Florida Recruiting
VIN-Julie Schwartzbard Aventura Florida Recruiting
Merritt Island Medical Research, LLC Merritt Island Florida Recruiting
Renstar Medical Research Ocala Florida Recruiting
Alzheimer's Research and Treatment Center Stuart Florida Recruiting
Charter Research - Lady Lake The Villages Florida Recruiting
Local Institution - 0016 Columbus Georgia Withdrawn
Center for Advanced Research & Education Gainesville Georgia Recruiting
Re:Cognition Health - Chicago Chicago Illinois Recruiting
Ascension Alexian Brothers Elk Grove Village Illinois Recruiting
Boston Center for Memory Newton Massachusetts Recruiting
HealthPartners Neuroscience Center Saint Paul Minnesota Recruiting
Advanced Memory Research Institute of New Jersey Toms River New Jersey Recruiting
NYU Langone Health New York New York Recruiting
Local Institution - 0259 New York New York Active Not Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
AMC Research, LLC Matthews North Carolina Recruiting
Ohio State University Columbus Ohio Recruiting
NDx Clinical Research Inc. Dayton Ohio Recruiting
Summit Headlands Portland Oregon Recruiting
Local Institution - 0004 Abington Pennsylvania Withdrawn
Rhode Island Mood & Memory Research Institute East Providence Rhode Island Recruiting
Neurology Clinic, P.C. Cordova Tennessee Recruiting
Gadolin Research Beaumont Texas Recruiting
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) Buenos Aires Buenos Aires F.D. Recruiting
Local Institution - 0271 Buenos Aires Argentina Not Yet Recruiting
Fundación Lennox - Instituto Modelo de Neurología Córdoba Argentina Recruiting
Sanatorio Morra S.A. Córdoba Argentina Recruiting
Instituto Kremer Córdoba Argentina Recruiting
Southern Neurology Kogarah New South Wales Recruiting
KARA Institute for Neurological Diseases Macquarie Park New South Wales Recruiting
NeuroCentrix Carlton Victoria Recruiting
Neurodegenerative Disorders Research Perth Western Australia Recruiting
St Vincent's Hospital Sydney Limited Darlinghurst Australia Recruiting
Local Institution - 0168 Brasília Federal District Not Yet Recruiting
Instituto de Neurologia de Curitiba Curitiba Paraná Recruiting

+ 79 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 NCT06976216 on ClinicalTrials.gov ↗ ← All trials in the USA