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

Agitation in Dementia, Including Alzheimer's Disease Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 in the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02817906
• Other study ID #: ITI-007-201
• Status: Terminated
• Phase: Phase 3
• Start date: August 29, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: June 2021
• Source: Intra-Cellular Therapies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 177
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Agitation in Dementia, Including Alzheimer's Disease
• Alzheimer Disease
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• ITI-007

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intra-Cellular Therapies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks (28 Days)
Secondary	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).	4 weeks (28 Days)