Recruiting
Phase 3

KarXT & KarX-EC

Sponsor:

Bristol-Myers Squibb

Code:

NCT06976216

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

KarXT

KarX-EC

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Conditions

Alzheimer's Disease

Study ID

NCT06976216

Start date

Jul 14, 2025

Status verified date

Aug, 2026

Completion date

Feb 23, 2029

Anticipated

Primary completion date

Sep 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

586 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: KarXT + KarX-EC

placebo comparator: Placebo

Interventions

KarXT

Specified dose on specified days

KarX-EC

Specified dose on specified days

Placebo

Specified dose on specified days

Primary outcome measure

  • Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) [ Time Frame: At week 24 ]
  • Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) [ Time Frame: At week 24 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Healthy Brain Clinic

Recruiting

Long Beach, California, United States, 90804

Contacts

Dung Trinh, Site 0173

562-606-5999

Anderson Clinical Research

Recruiting

Redlands, California, United States, 92374

Contacts

Donald Anderson, Site 0008

909-792-9007

Mountain Neurological Research Center

Recruiting

Basalt, Colorado, United States, 81621

Contacts

Alison Allen, Site 0025

970-927-1141

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Raymond Turner, Site 0024

202-687-7337

JEM Research Institute

Recruiting

Atlantis, Florida, United States, 33462

Contacts

Linda Pao, Site 0154

561-968-2933

VIN-Julie Schwartzbard

Recruiting

Aventura, Florida, United States, 33180

Contacts

Julie Schwartzbard, Site 0128

833-732-2484

Merritt Island Medical Research, LLC

Recruiting

Merritt Island, Florida, United States, 32952

Contacts

Wasim Niazi, Site 0023

386-785-8009

Renstar Medical Research

Recruiting

Ocala, Florida, United States, 34470

Contacts

Anette Nieves, Site 0055

352-629-5800

Alzheimer's Research and Treatment Center

Recruiting

Stuart, Florida, United States, 34996

Contacts

Adam Falchook, Site 0263

561-209-2400

Charter Research - Lady Lake

Recruiting

The Villages, Florida, United States, 32162

Contacts

Jeffrey Norton, Site 0184

352-775-1000

Center for Advanced Research & Education

Recruiting

Gainesville, Georgia, United States, 30501

Contacts

Angela Ritter, Site 0125

770-519-5254

Re:Cognition Health - Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Antonio Iglesias, Site 0109

312-971-3318

Ascension Alexian Brothers

Recruiting

Elk Grove Village, Illinois, United States, 60007

Contacts

Concetta Forchetti, Site 0054

847-593-8553

Boston Center for Memory

Recruiting

Newton, Massachusetts, United States, 02459

Contacts

Paul Solomon, Site 0009

413-281-0577

HealthPartners Neuroscience Center

Recruiting

Saint Paul, Minnesota, United States, 55130

Contacts

Marcel Hungs, Site 0110

111-111-1111

Advanced Memory Research Institute of New Jersey

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Arun Singh, Site 0123

732-341-9500

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Martin Sadowski, Site 0101

212-263-5708

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

AMC Research, LLC

Recruiting

Matthews, North Carolina, United States, 28105

Contacts

Mohammad Bolouri, Site 0007

7043644000ext225

Ohio State University

Recruiting

Columbus, Ohio, United States, 43221

NDx Clinical Research Inc.

Recruiting

Dayton, Ohio, United States, 45459

Contacts

Joel Vandersluis, Site 0026

937-224-8200

Summit Headlands

Recruiting

Portland, Oregon, United States, 97210

Contacts

Scott Losk, Site 0067

503-279-8252

Rhode Island Mood & Memory Research Institute

Recruiting

East Providence, Rhode Island, United States, 02914

Contacts

john stoukides, Site 0056

401-435-8950

Neurology Clinic, P.C.

Recruiting

Cordova, Tennessee, United States, 38018

Contacts

Thomas Arnold, Site 0099

901-866-9252

Gadolin Research

Recruiting

Beaumont, Texas, United States, 77702

Contacts

Joseph Oommen, Site 0018

409-331-6040

OCT Research ULC

Recruiting

Kelowna, British Columbia, Canada, V1Y 1Z9

Contacts

Pieter Strauss, Site 0233

250-862-8141

Richmond Clinical Trials

Recruiting

Richmond, British Columbia, Canada, V6V 2L1

Contacts

Harris Lari, Site 0234

604-373-4954

Centricity Research Halifax Multispecialty

Recruiting

Halifax, Nova Scotia, Canada, B3S 1N2

Contacts

Kerrie Schoffer, Site 0236

902-609-6845 x7115

Ottawa Memory Clinic

Recruiting

Ottawa, Ontario, Canada, K1Z 1G3

Contacts

Richard Bergeron, Site 0237

1-613-702-1000

Toronto Memory Program

Recruiting

Toronto, Ontario, Canada, M3B 2S7

Contacts

Manpreet Kaur, Site 0235

416-386-9606

MoCA Research and Innovation Inc.

Recruiting

Greenfield Park, Quebec, Canada, J4V 2J2

Contacts

Ziad Nasreddine, Site 0238

450-672-7766

Diex Recherche Victoriaville

Recruiting

Victoriaville, Quebec, Canada, G6P 3Z8

Contacts

Ethel Bellavance, Site 0239

819-260-1172

ALPHA Recherche Clinique

Recruiting

Québec, Canada, G3K 2P8

Contacts

Claude Patry, Site 0264

418-847-1112

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Dementia
  • Cognitive Impairment
  • Kar-XT
  • KarX-EC
  • Mild Alzheimer's Disease
  • Moderate Alzheimer's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-04. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-20.