Alzheimer Disease / KarX-EC / Agitation · Phase 3 Trial

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 extension study of a combined xanomeline/trospium formulation (KarXT + KarX-EC) for agitation in Alzheimer's disease, currently recruiting, with no results yet available. The trial aims to evaluate long-term efficacy and safety over approximately 30 weeks in participants who completed earlier-phase parent trials.

What was studied

Phase 3, Interventional, Non Randomized, Single Group, Open label, Treatment purpose. Alzheimer Disease, Agitation; age from 55 Years; to 90 Years. Intervention: KarXT+KarX-EC. n = 650. 256 sites across 26 countries.

Key findings

Safety

This is a registry record with no results posted; efficacy and safety outcomes are not yet reported. Primary outcome is safety (TEAEs); efficacy endpoint(s) not specified in this registry entry.

Who this may help

This extension study will provide long-term safety and efficacy data on a dual-component formulation in a defined Alzheimer's population. Results, once available, could inform treatment guidelines for agitation in Alzheimer's disease, but clinical utility remains unknown pending completion and publication.

Plain-language summary

This is an active Phase 3 trial registration with no results posted; it describes a planned long-term extension study in a defined population but carries no efficacy or safety data yet.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (assessed at Up to approximately Week 30)

DesignPhase 3, Interventional, Non Randomized, Single Group, Open label, Treatment purpose

PopulationAlzheimer Disease, Agitation; age from 55 Years; to 90 Years

Sample size650

InterventionKarXT+KarX-EC

Setting256 sites across 26 countries

Reported figures

Quoted from the source exactly as published.

Planned sample size650

Primary outcome measureNumber of Participants With Treatment Emergent Adverse Events (TEAEs), up to approximately Week 30

Trial phasePhase 3

Clinical bottom line

Caveats

This is a registry record with no results posted; efficacy and safety outcomes are not yet reported.
Study is limited to completers of parent trials, which may introduce selection bias and limit generalizability.
Blinding status, allocation concealment method, and detailed statistical analysis plan are not described in the registry record.
Primary outcome is safety (TEAEs); efficacy endpoint(s) not specified in this registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 3 design with long-term follow-up; parent trial design and blinding status not stated.

Directness

strong

Directly evaluates efficacy and safety of the combined formulation in the target population.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Blinding, allocation concealment, and analysis plan not stated in registry record.

Sample adequacy

moderate

Estimated enrollment of 650 participants is adequate for Phase 3; extension study limited to parent trial completers.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06937229). This is a study registration, not published results. Lead sponsor: Bristol-Myers Squibb. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 650 participants (ESTIMATED). Conditions: Alzheimer Disease, Agitation. Interventions: DRUG: KarXT; DRUG: KarX-EC. Primary outcome measures: Number of Participants With Treatment Emergent Adverse Events (TEAEs) , Up to approximately Week 30. Brief summary: 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer DiseaseKarX-ECAgitationKarXTNCT06937229Bristol-Myers Squibb