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 (ADAGIO-2)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520612-34-00

Acronym

CN012-0024

Enrollment

Registered

2025-10-22

Start date

2025-11-28

Completion date

Unknown

Last updated

2025-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation Associated with Alzheimer’s Disease

Brief summary

Change from baseline to the end of treatment on the CMAI-IPA total score compared with placebo.

Detailed description

Change from baseline to the end of treatment on the CGI-S as it relates specifically to agitation compared with placebo.

Interventions

DRUGKarXT matching placebo

DRUGKarX-EC

DRUGKarXT

DRUGKarX-EC matching Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline to the end of treatment on the CMAI-IPA total score compared with placebo.	—

Secondary

Measure	Time frame
Change from baseline to the end of treatment on the CGI-S as it relates specifically to agitation compared with placebo.	—

Countries

Czechia, France, Hungary, Italy, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026