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A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)

Sponsored by Bristol-Myers Squibb

Quick Self-Assessment

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Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 23, 2026

Phase

Clinical Trial

Sponsor

Bristol-Myers Squibb

Enrollment Target

352

Start Date

Jul 2025

๐Ÿ“Š
1 of 352 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Who Can Participate

Inclusion Criteria

\- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology:. i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aฮฒ42/40 ratio in CSF, pTau181/Aฮฒ42 ratio in CSF or pTau217/Aฮฒ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay. ii) If no historical evidence available:. A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval. B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:.
Amyloid PET.
Aฮฒ42/40 ratio or pTau181/Aฮฒ42 ratio in CSF using an HA-authorized diagnostic assay.
Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
Have one identified caregiver who should have sufficient contact (approx

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

352 participants

๐ŸŽ‚

Age Range

55 Years - 90 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Bristol-Myers Squibb

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Scottsdale

Arizona

Location available
View Scottsdale location page
RECRUITING

Anaheim

California

Location available
View Anaheim location page
RECRUITING

La Jolla

California

Location available
View La Jolla location page
RECRUITING

Pomona

California

Location available
View Pomona location page
RECRUITING

Torrance

California

Location available
View Torrance location page
RECRUITING

Walnut Creek

California

Location available
View Walnut Creek location page
WITHDRAWN

Colorado Springs

Colorado

Location available
View Colorado Springs location page
NOT_YET_RECRUITING

Maitland

Florida

Location available
View Maitland location page
NOT_YET_RECRUITING

Maitland

Florida

Location available
View Maitland location page

๐Ÿ“ And 32 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

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Find More Alzheimers Disease Trials by City

Browse all alzheimers disease clinical trials in these cities โ€” not just this study.

Looking for Alzheimer's Disease Treatment in Scottsdale?

Join others in Arizona exploring innovative treatment options through clinical research

Alzheimer's Disease Treatment Options in Scottsdale, Arizona

If you're searching for Alzheimer's Disease treatment in Scottsdale, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Scottsdale, Anaheim, La Jolla and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Alzheimer's Disease. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 352 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Alzheimer's Disease?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Alzheimer's Disease

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Alzheimer's Disease Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07011732. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.