Recruiting
Phase 3

KarXT & KarX-EC

Sponsor:

Bristol-Myers Squibb

Code:

NCT06976203

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

NCT06976203

Start date

Jul 21, 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 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

Fullerton Neurology and Headache Center

Recruiting

Fullerton, California, United States, 92835

Contacts

Jack Florin, Site 0072

714-381-0801

Irvine Clinical Research

Recruiting

Irvine, California, United States, 92614

Contacts

Elly Lee, Site 0095

949-753-1663

Inglewood Clinical

Recruiting

Los Angeles, California, United States, 90056

Contacts

Edward Zamrini, Site 0091

706-863-9595

Stanford Neuroscience Health Center

Recruiting

Palo Alto, California, United States, 94304

Contacts

Sharon Sha, Site 0083

000-000-0000

Research of the Rockies

Recruiting

Colorado Springs, Colorado, United States, 80919

Contacts

Adam Wolff, Site 0088

303-715-9024

Neuropsychiatric Research Center of Southwest Florida

Recruiting

Fort Myers, Florida, United States, 33912

Contacts

Jennifer Springer, Site 0090

239-939-7777

Jacksonville Center for Clinical Research

Recruiting

Jacksonville, Florida, United States, 32216

Contacts

Steven Toenjes, Site 0092

904-673-1252

K2 MEDICAL Research THE VILLAGES

Recruiting

Lady Lake, Florida, United States, 32159

Contacts

Craig Curtis, Site 0114

407-426-9299

Intercoastal Medical Group

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Mauricio Concha, Site 0082

941-203-3750

USF Health Byrd Alzheimer's Institute

Recruiting

Tampa, Florida, United States, 33613

Contacts

Amanda Smith, Site 0084

813-974-4355

Alzheimer's Research and Treatment Center

Recruiting

Wellington, Florida, United States, 33414

Contacts

David Watson, Site 0089

561-209-2400

Great Lakes Clinical Trials - Andersonville

Recruiting

Chicago, Illinois, United States, 60640

Contacts

Jeffrey Ross, Site 0093

847-252-7300

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Jennifer Arnold, Site 0070

217-545-7197

Josephson Wallack Munshower Neurology, PC

Recruiting

Indianapolis, Indiana, United States, 46256

Contacts

Kristi George, Site 0071

317-537-6088

QUEST Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

Aaron Ellenbogen, Site 0073

248-957-8940

Private Practice - Dr. Ronald Louis Schwartz

Recruiting

Hattiesburg, Mississippi, United States, 39401

Contacts

Ronald Schwartz, Site 0085

601-606-0911

The Cognitive and Research Center of New Jersey

Recruiting

Springfield, New Jersey, United States, 07081

Contacts

Raminder Parihar, Site 0094

973-850-4622

Advanced Clinical Institute

Recruiting

West Long Branch, New Jersey, United States, 07764

Contacts

Mark Ornstein, Site 0075

732-807-4700

Neurological Associates Albany

Recruiting

Albany, New York, United States, 12208

Contacts

Richard Holub, Site 0077

518-426-0575

Dent Neurosciences Research Center, Inc

Recruiting

Amherst, New York, United States, 14226

Contacts

Horacio Capote, Site 0068

716-250-2000

University at Buffalo - UBMD Neurology

Recruiting

Buffalo, New York, United States, 14203

Contacts

Kinga Szigeti, Site 0087

281-630-2316

Keystone Clinical Studies

Recruiting

Plymouth Meeting, Pennsylvania, United States, 19462

Contacts

Cameron Olezene, Site 0105

610-277-8073

Central Texas Neurology Consultants, PA

Recruiting

Round Rock, Texas, United States, 78681

Contacts

Elizabeth Peckham, Site 0079

443-852-2085

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 12, 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 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-12.