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

• ClinicalTrials.gov Identifier: NCT02817906
• Recruitment Status: Terminated
• First Posted: June 29, 2016
• Results First Posted: June 29, 2021
• Last Update Posted: June 29, 2021
• Sponsor: Intra-Cellular Therapies, Inc.
• Information provided by (Responsible Party): Intra-Cellular Therapies, Inc.

Tracking Information

• First Submitted Date: June 27, 2016
• First Posted Date: June 29, 2016
• Results First Submitted Date: May 13, 2021
• Results First Posted Date: June 29, 2021
• Last Update Posted Date: June 29, 2021
• Actual Study Start Date: August 29, 2016
• Actual Primary Completion Date: January 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2021)

Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) [ Time Frame: 4 weeks (28 Days) ]

The Cohen-Mansfield Agitation Inventory-Community Version is a 37-item scale for identifying and quantifying agitated behaviors in elderly persons in a community setting. Each item is rated from 1='Never' to 7='Several Times Per Hour'. Each category contains a pre-specified subset of the CMAI-C items. The score of each category is the sum of the CMAI-C items included in that category: Aggressive Behavior-Sum of 9 CMAI-C items, ranges from 9 to 63; Non-Aggressive Agitated Behavior-Sum of 6 CMAI-C items, ranges from 6 to 42; Verbally Agitated Behavior-Sum of 4 CMAI-C items, ranges from 4 to 28.

• Original Primary Outcome Measures (submitted: June 27, 2016): Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) [ Time Frame: 4 weeks ]

Current Secondary Outcome Measures (submitted: June 8, 2021)

Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S) [ Time Frame: 4 weeks (28 Days) ]

The CGI scale for Severity of Illness is a standardized assessment tool to rate the overall severity of illness and efficacy of medication. CGI-S of Agitation and CGI-S of Aggression will be used in this study as a measure of efficacy. Scores on the CGI-S range from 1 (not ill at all) to 7 (among the most extremely ill).

• Original Secondary Outcome Measures (submitted: June 27, 2016): Clinical Global Impression Scale for Severity of Illness (CGI-S) [ Time Frame: 4 weeks ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
• 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
• Brief 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Agitation in Dementia, Including Alzheimer's Disease

Intervention

• Drug: ITI-007
• Drug: Placebo

Study Arms

• Experimental: ITI-007
  9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.
  Intervention: Drug: ITI-007
• Placebo Comparator: Placebo
  Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 18, 2018): 177
• Original Estimated Enrollment (submitted: June 27, 2016): 360
• Actual Study Completion Date: January 30, 2019
• Actual Primary Completion Date: January 30, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02817906
• Other Study ID Numbers: ITI-007-201
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Intra-Cellular Therapies, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Intra-Cellular Therapies, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Susan Kozauer, M.D.; Intra-Cellular Therapies, Inc.

• PRS Account: Intra-Cellular Therapies, Inc.
• Verification Date: June 2021