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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817906
Recruitment Status : Terminated (Pre-specified Interim Analysis Indicated Futility)
First Posted : June 29, 2016
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Tracking Information
First Submitted Date  ICMJE June 27, 2016
First Posted Date  ICMJE June 29, 2016
Results First Submitted Date  ICMJE May 13, 2021
Results First Posted Date  ICMJE June 29, 2021
Last Update Posted Date June 29, 2021
Actual Study Start Date  ICMJE August 29, 2016
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2016)
Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2021)
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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2016)
Clinical Global Impression Scale for Severity of Illness (CGI-S) [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Agitation in Dementia, Including Alzheimer's Disease
Intervention  ICMJE
  • Drug: ITI-007
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: ITI-007
    9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
    Intervention: Drug: ITI-007
  • Placebo Comparator: Placebo
    Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 18, 2018)
177
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2016)
360
Actual Study Completion Date  ICMJE January 30, 2019
Actual Primary Completion Date January 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02817906
Other Study ID Numbers  ICMJE ITI-007-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Intra-Cellular Therapies, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Intra-Cellular Therapies, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Susan Kozauer, M.D. Intra-Cellular Therapies, Inc.
PRS Account Intra-Cellular Therapies, Inc.
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP