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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

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Trial Profile

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 of Trial: Phase II

Latest Information Update: 01 Oct 2026

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Agitation
  • Focus Therapeutic Use
  • Sponsors Intra-Cellular Therapies

Most Recent Events

  • 06 Jul 2026 Planned End Date changed from 1 Nov 2027 to 28 Dec 2027.
  • 06 Jul 2026 Planned primary completion date changed from 1 Oct 2027 to 28 Dec 2027.
  • 23 Oct 2024 Status changed from planning to recruiting.

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