Study Stopped
Pre-specified Interim Analysis Indicated Futility
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
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
1 other identifier
interventional
177
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2016
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 29, 2016
CompletedStudy Start
First participant enrolled
August 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedResults Posted
Study results publicly available
June 29, 2021
CompletedJune 29, 2021
June 1, 2021
2.4 years
June 27, 2016
May 13, 2021
June 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
4 weeks (28 Days)
Study Arms (2)
ITI-007
EXPERIMENTAL9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
Placebo
PLACEBO COMPARATORPlacebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Unable to comply with study procedures
- Considered medically inappropriate for study participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Unknown Facility
Sun City, Arizona, United States
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
Rogers, Arkansas, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Glendale, California, United States
Unknown Facility
Irvine, California, United States
Unknown Facility
Lemon Grove, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Oceanside, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
Santa Ana, California, United States
Unknown Facility
Hallandale, Florida, United States
Unknown Facility
Hialeah, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Suwanee, Georgia, United States
Unknown Facility
Honolulu, Hawaii, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Berlin, New Jersey, United States
Unknown Facility
Marlton, New Jersey, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
Brooklyn, New York, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Centerville, Ohio, United States
Unknown Facility
Dayton, Ohio, United States
Unknown Facility
San Antonio, Texas, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
CMAI-C Factor Composite score (Aggressive Behavior, Non-Aggressive Agitated Behavior, Verbally Agitated Behavior) was the primary efficacy measure not the CMAI-C Total score.
Results Point of Contact
- Title
- ITI Clinical Trials
- Organization
- Intra-Cellular Therapies, Inc.
Study Officials
- STUDY DIRECTOR
Susan Kozauer, M.D.
Intra-Cellular Therapies, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2016
First Posted
June 29, 2016
Study Start
August 29, 2016
Primary Completion
January 30, 2019
Study Completion
January 30, 2019
Last Updated
June 29, 2021
Results First Posted
June 29, 2021
Record last verified: 2021-06