ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
NCT ID: NCT02817906
Last Updated: 2021-06-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
177 participants
INTERVENTIONAL
2016-08-29
2019-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ITI-007
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
ITI-007
Placebo
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Placebo
Interventions
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ITI-007
Placebo
Eligibility Criteria
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Inclusion Criteria
* Clinically significant symptoms of agitation secondary to probable Alzheimer's disease
* Able to attend outpatient clinic visits with primary caregiver
Exclusion Criteria
* Considered medically inappropriate for study participation
55 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Susan Kozauer, M.D.
Role: STUDY_DIRECTOR
Intra-Cellular Therapies, Inc.
Locations
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Sun City, Arizona, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
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
Hallandale, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Suwanee, Georgia, United States
Honolulu, Hawaii, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Marlton, New Jersey, United States
Toms River, New Jersey, United States
Brooklyn, New York, United States
Staten Island, New York, United States
Centerville, Ohio, United States
Dayton, Ohio, United States
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ITI-007-201
Identifier Type: -
Identifier Source: org_study_id
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