CN0120056: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated with Alzheimer’s Disease (ADEPT-4)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516363-92-00

Acronym

CN0120056

Enrollment

Registered

2025-03-24

Start date

2025-04-08

Completion date

Unknown

Last updated

2026-01-26

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

Conditions

Psychosis Associated with Alzheimer’s Disease

Brief summary

The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.

Detailed description

The key secondary endpoint is the change from Baseline to End of Treatment on CGI-S score.

Interventions

DRUGKarXT

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The main endpoint is the change from Baseline to End of Treatment in NPI-C: H+D score.	—

Secondary

Measure	Time frame
The key secondary endpoint is the change from Baseline to End of Treatment on CGI-S score.	—

Countries

Belgium, Bulgaria, Croatia, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

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