A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI1284 in Patients with Psychosis Associated with Alzheimer’s Disease

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513035-25-00

Acronym

ITI-1284-201

Enrollment

216

Registered

2025-05-12

Start date

2025-07-11

Completion date

Unknown

Last updated

2026-01-21

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 change from baseline to end of Week 6 in BEHAVE-AD psychosis subscale score

Detailed description

the change from baseline to end of Week 6 in CGI-S score

Interventions

DRUGITI-1284

DRUGITI-1284 placebo tablets are yellow to off-yellow-cream

DRUGcircular

DRUGfreeze-dried units

DRUGdebossed with a diamond matching the active tablets. The placebo matches both the 10 mg and 20 mg active tablet.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
the change from baseline to end of Week 6 in BEHAVE-AD psychosis subscale score	—

Secondary

Measure	Time frame
the change from baseline to end of Week 6 in CGI-S score	—

Countries

Bulgaria, Croatia, Czechia, Italy, Poland, Romania, Slovakia, Spain

Outcome results

None listed

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