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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
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

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.

Condition or disease Intervention/treatment Phase
Agitation in Dementia, Including Alzheimer's Disease Drug: ITI-007 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 29, 2016
Actual Primary Completion Date : January 30, 2019
Actual Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817906

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United States, Arizona
Sun City, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
United States, California
Costa Mesa, California, United States
Glendale, California, United States
Irvine, California, United States
Lemon Grove, California, United States
Long Beach, California, United States
Oceanside, California, United States
Riverside, California, United States
Santa Ana, California, United States
United States, Florida
Hallandale Beach, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
United States, Georgia
Suwanee, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Berlin, New Jersey, United States
Marlton, New Jersey, United States
Toms River, New Jersey, United States
United States, New York
Brooklyn, New York, United States
Staten Island, New York, United States
United States, Ohio
Centerville, Ohio, United States
Dayton, Ohio, United States
United States, Texas
San Antonio, Texas, United States
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
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Study Director: Susan Kozauer, M.D. Intra-Cellular Therapies, Inc.
  Study Documents (Full-Text)

Documents provided by Intra-Cellular Therapies, Inc.:
Study Protocol  [PDF] October 22, 2018
Statistical Analysis Plan  [PDF] October 23, 2018

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Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02817906    
Other Study ID Numbers: ITI-007-201
First Posted: June 29, 2016    Key Record Dates
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations