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

June 8, 2021 updated by: Intra-Cellular Therapies, Inc.

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Sun City, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
      • Rogers, Arkansas, United States
    • California
      • Costa Mesa, California, United States
      • Glendale, California, United States
      • Irvine, California, United States
      • Lemon Grove, California, United States
      • Long Beach, California, United States
      • Oceanside, California, United States
      • Riverside, California, United States
      • Santa Ana, California, United States
    • Florida
      • Hallandale Beach, Florida, United States
      • Hialeah, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
    • Georgia
      • Suwanee, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
      • Marlton, New Jersey, United States
      • Toms River, New Jersey, United States
    • New York
      • Brooklyn, New York, United States
      • Staten Island, New York, United States
    • Ohio
      • Centerville, Ohio, United States
      • Dayton, Ohio, United States
    • Texas
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ITI-007
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
Drug: ITI-007
Placebo Comparator: Placebo
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Time Frame: 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.
4 weeks (28 Days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
Time Frame: 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).
4 weeks (28 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intra-Cellular Therapies, Inc.

Investigators

  • Study Director: Susan Kozauer, M.D., Intra-Cellular Therapies, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2016

Primary Completion (Actual)

January 30, 2019

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

June 27, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Actual)

June 29, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-007-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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