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

NCT02817906 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2021-06-29

Study results available
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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.

Conditions

  • Agitation in Dementia, Including Alzheimer's Disease

Interventions

DRUG

ITI-007

DRUG

Placebo

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Kozauer, M.D. · Intra-Cellular Therapies, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-29
Primary Completion
2019-01-30
Completion
2019-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02817906 on ClinicalTrials.gov