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

Intra-Cellular Therapies

Status and phase: Terminated; Phase 3

Conditions: Agitation in Dementia, Including Alzheimer's Disease

Treatments: Drug: Placebo; Drug: ITI-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT02817906

ITI-007-201

Details and patient eligibility

About

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.

Enrollment: 177 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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177 participants in 2 patient groups, including a placebo group

ITI-007

Experimental group

Description:

9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.

Treatment:

Drug: ITI-007

Placebo

Placebo Comparator group

Description:

Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks

Treatment:

Drug: Placebo