ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

• Status: Terminated
• Trial end date: 2019-01-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-blind, placebo-controlled study comparing the efficacy and safety of ITI-007 versus placebo administered orally once daily in the treatment of agitation in patients with dementia, including Alzheimer's disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Intra-Cellular Therapies, Inc.

Criteria

Inclusion Criteria:

• Clinical diagnosis of probable Alzheimer's disease

• Clinically significant symptoms of agitation secondary to probable Alzheimer's disease

• Able to attend outpatient clinic visits with primary caregiver

Exclusion Criteria:

• Unable to comply with study procedures

• Considered medically inappropriate for study participation