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

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Intra-Cellular Therapies, Inc.
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT02817906
First received: June 27, 2016
Last updated: August 14, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Agitation in Dementia, Including Alzheimer's Disease Drug: ITI-007 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Intra-Cellular Therapies, Inc.:

Primary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) [ Time Frame: 4 weeks ]

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

Estimated Enrollment: 360
Actual Study Start Date: June 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02817906

Contacts
Contact: Kimberly Vanover, Ph.D. itciclinicaltrials@intracellulartherapies.com

Locations
United States, Arizona
Recruiting
Sun City, Arizona, United States
United States, Arkansas
Recruiting
Little Rock, Arkansas, United States
Recruiting
Rogers, Arkansas, United States
United States, California
Recruiting
Costa Mesa, California, United States
Recruiting
Glendale, California, United States
Recruiting
Irvine, California, United States
Recruiting
Lemon Grove, California, United States
Recruiting
Long Beach, California, United States
Recruiting
Oceanside, California, United States
Recruiting
Riverside, California, United States
Recruiting
San Diego, California, United States
Recruiting
Santa Ana, California, United States
United States, Florida
Recruiting
Hallandale Beach, Florida, United States
Recruiting
Hialeah, Florida, United States
Recruiting
Miami, Florida, United States
Recruiting
Orlando, Florida, United States
United States, Georgia
Recruiting
Suwanee, Georgia, United States
United States, Hawaii
Recruiting
Honolulu, Hawaii, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New Jersey
Recruiting
Berlin, New Jersey, United States
Recruiting
Marlton, New Jersey, United States
Recruiting
Toms River, New Jersey, United States
United States, New York
Recruiting
Brooklyn, New York, United States
Recruiting
Staten Island, New York, United States
United States, Ohio
Recruiting
Centerville, Ohio, United States
Recruiting
Dayton, Ohio, United States
United States, Texas
Recruiting
San Antonio, Texas, United States
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
Study Director: Kimberly Vanover, Ph.D. Intra-Cellular Therapies, Inc.
  More Information

Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02817906     History of Changes
Other Study ID Numbers: ITI-007-201
Study First Received: June 27, 2016
Last Updated: August 14, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 23, 2017