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Looking for participantsPhase3

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Sponsor: Bristol-Myers Squibb

NCT ID: NCT06937229

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
KarXT (drug), KarX-EC (drug)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
KarXT — drug: Specified dose on specified days · KarX-EC — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
55 Years to 90 Years
Who
All
Number of participants
650
Started
2025-12-02
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for alzheimer disease
  • • Phase3 - 650 participants
  • • The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024

Who can take part?

  • • Ages 55 Years to 90 Years
  • • Diagnosed with alzheimer disease

Where?

  • • Preston - Local Institution - 2505
  • • Chertsey - Surrey and Borders Partnership NHS Foundation Trust
  • • Cambridge - Local Institution - 2502
  • • London - Local Institution - 2501
  • • +6 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Alzheimer DiseaseAgitation

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 55 Years - 90 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ completed study CN012-0023 or CN012-0024 per protocol
  • ✓ an identified caregiver who has sufficient contact (approximately 8 hours over a week)

What the study is looking for

  • ✓Participants must have completed study CN012-0023 or CN012-0024 per protocol.
  • ✓Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

Who cannot take part

  • ✗Other protocol-defined Inclusion/Exclusion criteria apply.
See the full criteria
Inclusion Criteria: * Participants must have completed study CN012-0023 or CN012-0024 per protocol. * Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week). Exclusion Criteria: * Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. * Other protocol-defined Inclusion/Exclusion criteria apply.

Where Is This Study? (10 UK sites)

Local Institution - 2505

Preston PR2 9HT, United Kingdom

NOT_YET_RECRUITING

Surrey and Borders Partnership NHS Foundation Trust

Chertsey KT16 9AU, United Kingdom

Recruiting
Site contact (verified)
Ramin Nilforooshan, Site 2508+44 300 555 5222

Local Institution - 2502

Cambridge CB21 5EF, United Kingdom

NOT_YET_RECRUITING

Local Institution - 2501

London SE5 8AZ, United Kingdom

NOT_YET_RECRUITING

Local Institution - 2500

London W12 0NN, United Kingdom

NOT_YET_RECRUITING

NeuroClin Glasgow

Motherwell ML1 4UF, United Kingdom

Recruiting
Site contact (verified)
Jennifer Lynch, Site 2510+44 141 948 0206

Cornwall Partnership NHS Foundation Trust

Redruth TR15 3QE, United Kingdom

Recruiting
Site contact (verified)
Nicholas Jacobsen, Site 2507+44 1208 251 300

Local Institution - 2504

Sheffield S5 7JT, United Kingdom

NOT_YET_RECRUITING

Local Institution - 2509

Stafford ST16 3SR, United Kingdom

WITHDRAWN

Local Institution - 2503

Wolverhampton WV4 5HN, United Kingdom

NOT_YET_RECRUITING

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

Sponsor contact

CONTACT

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

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09