NCT06651567

A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This is 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

Detailed description

The study will be conducted in 3 periods: * Screening Period (up to 4 weeks) during which patient eligibility will be assessed; * Double-blind Treatment Period (12 weeks) during which all patients will be randomized in a 1:1 ratio to receive either ITI-1284 or placebo; * Safety Follow-up Period (30 days) during which all patients will return for a safety follow-up visit approximately 30 days after the last dose of study drug.

Conditions

• Agitation Associated With Alzheimer's Dementia

Interventions

Type	Name	Description
DRUG	ITI-1284	ITI-1284 10 mg or 20 mg rapidly disintegrating tablet, taken once daily, sublingual administration
DRUG	Placebo	Placebo rapidly disintegrating tablet, taken once daily, sublingual administration

Timeline

• Start date: 2024-10-22
• Primary completion: 2027-10-01
• Completion: 2027-11-01
• First posted: 2024-10-21
• Last updated: 2026-01-12

Locations

69 sites across 8 countries: United States, Bulgaria, Croatia, Czechia, Romania, Serbia, Slovakia, Spain

Regulatory

• FDA-regulated drug study