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KarXT + KarX-EC for Agitation in Alzheimer's Disease

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

Recruiting Phase 3 Interventional Study
Alzheimer Disease Agitation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
55 – 90
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
650 (estimated)
Sponsor
Bristol-Myers Squibb · Industry
Who this trial is looking for

This trial is looking for people with agitation related to Alzheimer's Disease who have completed earlier studies. Participants will take a combination of two specific medications to see how well they work over time and if they are safe.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have completed study CN012-0023 or CN012-0024.
  • I have a caregiver who can be in contact with me for about 8 hours a week.

You may not be able to join if

  • I have serious heart problems.
  • I have serious lung problems.
  • I have serious kidney problems.
  • I have serious blood problems.
  • I have serious digestive problems.
  • I have serious hormone problems.
  • I have serious immune system problems.
  • I have serious skin problems.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
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.

Trial Locations

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Eligibility 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 cardiovascul…
Contacts

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

855-907-3286

Clinical.Trials@bms.com

CONTACT

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

CONTACT

NCT ID: NCT06937229 Source: ClinicalTrials.gov