Clinical trialNCT02817906TerminatedPhase 3Interventional

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

SponsorIntra-Cellular Therapies, Inc.Enrollment177Agitation in Dementia, Including Alzheimer's Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Susan Kozauer, M.D.
Intra-Cellular Therapies, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

26 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Facility name not stated
Sun City, Arizona, United States
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Little Rock, Arkansas, United States
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Rogers, Arkansas, United States
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Costa Mesa, California, United States
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Glendale, California, United States
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Irvine, California, United States
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Lemon Grove, California, United States
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Long Beach, California, United States
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Oceanside, California, United States
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Riverside, California, United States
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Santa Ana, California, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Suwanee, Georgia, United States
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Honolulu, Hawaii, United States
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Las Vegas, Nevada, United States
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Berlin, New Jersey, United States
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Marlton, New Jersey, United States
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Toms River, New Jersey, United States
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Brooklyn, New York, United States
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Staten Island, New York, United States
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Centerville, Ohio, United States
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Dayton, Ohio, United States
Facility name not stated
San Antonio, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ITI-007Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 29 Aug 2016
Primary completion: 30 Jan 2019
Completion: 30 Jan 2019
Last update posted: 29 Jun 2021
Registered enrollment: 177
Registry id: NCT02817906

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.