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

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ClinicalTrials.gov Identifier: NCT02817906
Recruitment Status : Recruiting
First Posted : June 29, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

June 27, 2016
June 29, 2016
November 13, 2017
June 2016
August 2018   (Final data collection date for primary outcome measure)
Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) [ Time Frame: 4 weeks ]
Same as current
Complete list of historical versions of study NCT02817906 on ClinicalTrials.gov Archive Site
Clinical Global Impression Scale for Severity of Illness (CGI-S) [ Time Frame: 4 weeks ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Agitation in Dementia, Including Alzheimer's Disease
  • Drug: ITI-007
  • Drug: Placebo
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
Same as current
August 2018
August 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
No
Contact: Kimberly Vanover, Ph.D. itciclinicaltrials@intracellulartherapies.com
United States
 
 
NCT02817906
ITI-007-201
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc.
Not Provided
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc.
Intra-Cellular Therapies, Inc.
March 2017

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