Back to resultsITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Primary Purpose
Agitation in Dementia, Including Alzheimer's Disease
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ITI-007
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Agitation in Dementia, Including Alzheimer's Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ITI-007
Placebo
Arm Description
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT02817906
First Posted
June 27, 2016
Last Updated
June 8, 2021
Sponsor
Intra-Cellular Therapies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02817906
Brief Title
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Pre-specified Interim Analysis Indicated Futility
Study Start Date
August 29, 2016 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Intra-Cellular Therapies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation in Dementia, Including Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
177 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ITI-007
Arm Type
Experimental
Arm Description
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
ITI-007
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Description
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 Outcome Measure Information:
Title
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Kozauer, M.D.
Organizational Affiliation
Intra-Cellular Therapies, Inc.
Official's Role
Study Director
Facility Information:
City
Sun City
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Rogers
State/Province
Arkansas
Country
United States
City
Costa Mesa
State/Province
California
Country
United States
City
Glendale
State/Province
California
Country
United States
City
Irvine
State/Province
California
Country
United States
City
Lemon Grove
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
Santa Ana
State/Province
California
Country
United States
City
Hallandale Beach
State/Province
Florida
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Suwanee
State/Province
Georgia
Country
United States
City
Honolulu
State/Province
Hawaii
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Berlin
State/Province
New Jersey
Country
United States
City
Marlton
State/Province
New Jersey
Country
United States
City
Toms River
State/Province
New Jersey
Country
United States
City
Brooklyn
State/Province
New York
Country
United States
City
Staten Island
State/Province
New York
Country
United States
City
Centerville
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
We'll reach out to this number within 24 hrs