Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Xanomeline/Trospium Chloride Capsule for Alzheimer Disease

This study wants to measure the how well it works and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Official registry: https://clinicaltrials.gov/study/NCT07011732 · Bristol-Myers Squibb · enrollment listed as 426

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

They plan to enroll about 426 people at 157 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Interventions: Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo

Primary outcome (registry wording): Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14

Who it is for (from inclusion criteria)

  • Ages 55 Years to 90 Years
  • 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:
  • Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay
  • Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1)
  • Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
  • History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1)
  • AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2)

Public study contact (from the registry)

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

157 listed

+ 116 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07011732 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07011732?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07011732?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary