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

Phase 3TerminatedNCT02817906

Intra-Cellular Therapies, Inc.177 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

177

Conditions

Agitation in Dementia, Including Alzheimer's Disease

Interventions

ITI-007DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (26)

Unnamed facility

Sun City, Arizona, United States

Unnamed facility

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

The Cohen-Mansfield Agitation Inventory-Community Version is a 37-item scale for identifying and quantifying agitated behaviors in elderly persons in a community setting. Each item is rated from 1='Never' to 7='Several Times Per Hour'. Each category contains a pre-specified subset of the CMAI-C items. The score of each category is the sum of the CMAI-C items included in that category: Aggressive Behavior-Sum of 9 CMAI-C items, ranges from 9 to 63; Non-Aggressive Agitated Behavior-Sum of 6 CMAI-C items, ranges from 6 to 42; Verbally Agitated Behavior-Sum of 4 CMAI-C items, ranges from 4 to 28.

Time frame: 4 weeks (28 Days)

Secondary Outcomes

Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)

The CGI scale for Severity of Illness is a standardized assessment tool to rate the overall severity of illness and efficacy of medication. CGI-S of Agitation and CGI-S of Aggression will be used in this study as a measure of efficacy. Scores on the CGI-S range from 1 (not ill at all) to 7 (among the most extremely ill).

Time frame: 4 weeks (28 Days)

Data from ClinicalTrials.gov

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