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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817906
Recruitment Status : Terminated (Pre-specified Interim Analysis Indicated Futility)
First Posted : June 29, 2016
Results First Posted : June 29, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.

Study Type Interventional
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
Interventions Drug: ITI-007
Drug: Placebo
Enrollment 177
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ITI-007 9 mg Placebo
Hide Arm/Group Description

9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks.

ITI-007(lumateperone tosylate) 9 mg is equivalent to 6 mg lumateperone, the free base or active moiety.

Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Period Title: Overall Study
Started [1] 86 [2] 89 [3]
Completed [4] 70 84
Not Completed 16 5
Reason Not Completed
Adverse Event             3             0
Lack of Efficacy             1             0
Protocol Violation             1             1
Study Terminated by Sponsor             2             2
Withdrawal by Subject             7             0
Other             2             2
[1]
Part A-Number of subjects treated
[2]
87 patients were randomized but only 86 received study drug. The number completed and discontinued is based on the 86 patients that received study drug.
[3]
90 patients were randomized but only 89 received study drug. The number completed and discontinued is based on 89 patients that received study drug.
[4]
Part A
Arm/Group Title 9 mg ITI-007 Placebo Total
Hide Arm/Group Description 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 86 89 175
Hide Baseline Analysis Population Description
Safety Analysis Set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 89 participants 175 participants
75.6  (8.64) 74.1  (8.61) 74.8  (8.63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 89 participants 175 participants
Female
44
  51.2%
57
  64.0%
101
  57.7%
Male
42
  48.8%
32
  36.0%
74
  42.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 89 participants 175 participants
White
73
  84.9%
75
  84.3%
148
  84.6%
Black or African American
10
  11.6%
10
  11.2%
20
  11.4%
Asian
3
   3.5%
1
   1.1%
4
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.1%
1
   0.6%
Multiple
0
   0.0%
1
   1.1%
1
   0.6%
Unknown
0
   0.0%
1
   1.1%
1
   0.6%
CMAI-C   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 86 participants 89 participants 175 participants
CMAI-C Aggressive Behavior 13.28  (4.51) 14.08  (5.92) 13.69  (5.27)
CMAI-C Non-Aggressive Agitated Behavior 17.20  (7.42) 17.46  (7.05) 17.33  (7.22)
CMAI-C Verbally Agitated Behavior 15.37  (4.95) 15.65  (5.02) 15.51  (4.98)
[1]
Measure Description: 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.
1.Primary Outcome
Title Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)
Hide Description 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.
Time Frame 4 weeks (28 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Set (Study stopped for futility)
Arm/Group Title 9 mg ITI-007 Placebo
Hide Arm/Group Description:
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Overall Number of Participants Analyzed 78 84
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Aggressive Agitated Behavior -1.0  (0.37) -2.3  (0.33)
Non-Aggressive Agitated Behavior -4.1  (0.72) -3.9  (0.65)
Verbally Agitated Behavior -2.9  (0.49) -2.3  (0.45)
2.Secondary Outcome
Title Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)
Hide Description

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).

Time Frame 4 weeks (28 Days)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat Set
Arm/Group Title 9 mg ITI-007 Placebo
Hide Arm/Group Description:
9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
Overall Number of Participants Analyzed 78 84
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
CGI-S Aggression -0.4  (0.12) -0.6  (0.10)
CGI-S Agitation -0.8  (0.11) -0.9  (0.10)
Time Frame 4 weeks of double blind treatment.
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title 9 mg ITI-007 Placebo
Hide Arm/Group Description 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
All-Cause Mortality
9 mg ITI-007 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/86 (0.00%)   0/89 (0.00%) 
Hide Serious Adverse Events
9 mg ITI-007 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/86 (2.33%)   1/89 (1.12%) 
Infections and infestations     
Urinary tract infection   1/86 (1.16%)  0/89 (0.00%) 
Acarodermatitis   0/86 (0.00%)  1/89 (1.12%) 
Investigations     
Ammonia Increased   1/86 (1.16%)  0/89 (0.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
9 mg ITI-007 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/86 (15.12%)   8/89 (8.99%) 
Gastrointestinal disorders     
Nausea   3/86 (3.49%)  0/89 (0.00%) 
Vomiting   2/86 (2.33%)  0/89 (0.00%) 
Constipation   2/86 (2.33%)  0/89 (0.00%) 
Abdominal pain upper   0/86 (0.00%)  2/89 (2.25%) 
Infections and infestations     
Upper respiratory tract infection   2/86 (2.33%)  2/89 (2.25%) 
Injury, poisoning and procedural complications     
Fall   4/86 (4.65%)  1/89 (1.12%) 
Nervous system disorders     
Dizziness   4/86 (4.65%)  0/89 (0.00%) 
Headache   2/86 (2.33%)  1/89 (1.12%) 
Somnolence   0/86 (0.00%)  3/89 (3.37%) 
Indicates events were collected by systematic assessment
CMAI-C Factor Composite score (Aggressive Behavior, Non-Aggressive Agitated Behavior, Verbally Agitated Behavior) was the primary efficacy measure not the CMAI-C Total score.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: ITI Clinical Trials
Organization: Intra-Cellular Therapies, Inc.
Phone: 646-440-9333
EMail: ITCIClinicalTrials@itci-inc.com
Layout table for additonal information
Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT02817906    
Other Study ID Numbers: ITI-007-201
First Submitted: June 27, 2016
First Posted: June 29, 2016
Results First Submitted: May 13, 2021
Results First Posted: June 29, 2021
Last Update Posted: June 29, 2021