CN012-0025: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated with Alzheimer’s Disease (ADAGIO-3)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-519994-20-00

Acronym

CN012-0025

Enrollment

191

Registered

2025-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-27

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

Incidence of any Treatment-Emergent Adverse Events (TEAEs).

Detailed description

Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths, AEs of special interest, Assessment of abnormal involuntary movements or restlessness, Body weight, Blood pressure and heart rate, Laboratory evaluations, Suicidal ideation, Assessment of cognition, Assessment of urinary retention.

Interventions

DRUGKarXT

DRUGKarX-EC

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of any Treatment-Emergent Adverse Events (TEAEs).	—

Secondary

Measure	Time frame
Reported adverse events (AEs), TEAEs, serious AEs, and TEAEs leading to study withdrawal and deaths, AEs of special interest, Assessment of abnormal involuntary movements or restlessness, Body weight, Blood pressure and heart rate, Laboratory evaluations, Suicidal ideation, Assessment of cognition, Assessment of urinary retention.	—

Countries

Bulgaria, Croatia, Czechia, France, Greece, Hungary, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

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