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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: March 15, 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: 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

  Show 29 Study Locations
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: March 15, 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 June 29, 2017