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RecruitingPhase 3

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

Bristol-Myers Squibb · NCT06976203

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60–85 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
586
US sites recruiting
23
Study start
July 21, 2025
Record last updated
October 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: KarXT; KarX-EC; Placebo

Conditions: Alzheimer's Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Fullerton Neurology and Headache Center

    Fullerton, CA 92835

    Site contact: Jack Florin, Site 0072 · 714-381-0801

  • Irvine Clinical Research

    Irvine, CA 92614

    Site contact: Elly Lee, Site 0095 · 949-753-1663

  • Inglewood Clinical

    Los Angeles, CA 90056

    Site contact: Edward Zamrini, Site 0091 · 706-863-9595

  • Stanford Neuroscience Health Center

    Palo Alto, CA 94304

    Site contact: Sharon Sha, Site 0083 · 000-000-0000

  • Research of the Rockies

    Colorado Springs, CO 80919

    Site contact: Adam Wolff, Site 0088 · 303-715-9024

  • Neuropsychiatric Research Center of Southwest Florida

    Fort Myers, FL 33912

    Site contact: Jennifer Springer, Site 0090 · 239-939-7777

  • Jacksonville Center for Clinical Research

    Jacksonville, FL 32216

    Site contact: Steven Toenjes, Site 0092 · 904-673-1252

  • K2 MEDICAL Research THE VILLAGES

    Lady Lake, FL 32159

    Site contact: Craig Curtis, Site 0114 · 407-426-9299

  • Intercoastal Medical Group

    Sarasota, FL 34239

    Site contact: Mauricio Concha, Site 0082 · 941-203-3750

  • USF Health Byrd Alzheimer's Institute

    Tampa, FL 33613

    Site contact: Amanda Smith, Site 0084 · 813-974-4355

  • Alzheimer's Research and Treatment Center

    Wellington, FL 33414

    Site contact: David Watson, Site 0089 · 561-209-2400

  • Great Lakes Clinical Trials - Andersonville

    Chicago, IL 60640

    Site contact: Jeffrey Ross, Site 0093 · 847-252-7300

  • Southern Illinois University School of Medicine

    Springfield, IL 62702

    Site contact: Jennifer Arnold, Site 0070 · 217-545-7197

  • Josephson Wallack Munshower Neurology, PC

    Indianapolis, IN 46256

    Site contact: Kristi George, Site 0071 · 317-537-6088

  • QUEST Research Institute

    Farmington Hills, MI 48334

    Site contact: Aaron Ellenbogen, Site 0073 · 248-957-8940

  • Private Practice - Dr. Ronald Louis Schwartz

    Hattiesburg, MS 39401

    Site contact: Ronald Schwartz, Site 0085 · 601-606-0911

  • The Cognitive and Research Center of New Jersey

    Springfield, NJ 07081

    Site contact: Raminder Parihar, Site 0094 · 973-850-4622

  • Advanced Clinical Institute

    West Long Branch, NJ 07764

    Site contact: Mark Ornstein, Site 0075 · 732-807-4700

  • Neurological Associates Albany

    Albany, NY 12208

    Site contact: Richard Holub, Site 0077 · 518-426-0575

  • Dent Neurosciences Research Center, Inc

    Amherst, NY 14226

    Site contact: Horacio Capote, Site 0068 · 716-250-2000

  • University at Buffalo - UBMD Neurology

    Buffalo, NY 14203

    Site contact: Kinga Szigeti, Site 0087 · 281-630-2316

  • Keystone Clinical Studies

    Plymouth Meeting, PA 19462

    Site contact: Cameron Olezene, Site 0105 · 610-277-8073

  • Central Texas Neurology Consultants, PA

    Round Rock, TX 78681

    Site contact: Elizabeth Peckham, Site 0079 · 443-852-2085

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for… (NCT06976203) | Bored Studies