ClinicalTrials.gov

History of Changes for Study: NCT02817906
ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
Latest version (submitted June 8, 2021) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 27, 2016 None (earliest Version on record)
2 March 15, 2017 Study Status, Contacts/Locations and Oversight
3 August 14, 2017 Contacts/Locations and Study Status
4 November 8, 2017 Contacts/Locations and Study Status
5 December 18, 2018 Recruitment Status, Study Status, Contacts/Locations, Study Design
Show
Results Submission Events
6 June 8, 2021 Study Status, Outcome Measures, Document Section, Results, Contacts/Locations and Arms and Interventions
Comparison Format:

Scroll up to access the controls

Study NCT02817906
Submitted Date:  June 27, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: ITI-007-201
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
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2016
Overall Status: Recruiting
Study Start: June 2016
Primary Completion: August 2018 [Anticipated]
Study Completion:
First Submitted: June 27, 2016
First Submitted that
Met QC Criteria:
June 27, 2016
First Posted: June 29, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 27, 2016
Last Update Posted: June 29, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Intra-Cellular Therapies, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Agitation in Dementia, Including Alzheimer's Disease
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 360 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
[ Time Frame: 4 weeks ]

Secondary Outcome Measures:
1. Clinical Global Impression Scale for Severity of Illness (CGI-S)
[ Time Frame: 4 weeks ]

Open or close this module Eligibility
Minimum Age: 55 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Kimberly Vanover, Ph.D.
Email: kvanover@intracellulartherapies.com
Study Officials: Kimberly Vanover, Ph.D.
Study Director
Intra-Cellular Therapies, Inc.
Locations: United States, California
[Recruiting]
Lemon Grove, California, United States
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services