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

Phase 3

Terminated

• Conditions: Agitation in Dementia, Including Alzheimer's Disease
• Interventions: Drug: ITI-007; Drug: Placebo

• Registration Number: NCT02817906
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-27
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-29
• Study Start: 2016-08-29
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Results First Submitted: 2021-05-13
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-08
• Last Update Submitted: 2021-06-08
• Results First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 177

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

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Exclusion Criteria

• Unable to comply with study procedures
• Considered medically inappropriate for study participation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITI-007	ITI-007	9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
Placebo	Placebo	Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	4 weeks (28 Days)	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	4 weeks (28 Days)	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).