A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients with Agitation Associated with Alzheimer’s Dementia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514680-26-00

Acronym

ITI-1284-101

Enrollment

137

Registered

2025-05-27

Start date

2025-07-17

Completion date

Unknown

Last updated

2025-10-23

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 Dementia

Brief summary

The primary efficacy endpoint is the change from baseline to end of Week 12 in CMAI total score.

Detailed description

The key secondary efficacy endpoint: change from baseline to end of Week 12 in CGI-S score.

Interventions

DRUGITI-1284

DRUGPlacebo tablets matching the ITI-1284 10 mg and 20 mg active tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the change from baseline to end of Week 12 in CMAI total score.	—

Secondary

Measure	Time frame
The key secondary efficacy endpoint: change from baseline to end of Week 12 in CGI-S score.	—

Countries

Bulgaria, Croatia, Czechia, Romania, Slovakia, Spain

Outcome results

None listed

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