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Pre-specified Interim Analysis Indicated Futility
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITI-007 | Experimental | 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks. |
|
| Placebo | Placebo Comparator | Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ITI-007 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) | 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. | 4 weeks (28 Days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S) | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan Kozauer, M.D. | Intra-Cellular Therapies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun City | Arizona | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | ITI-007 9 mg | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 22, 2018 | May 13, 2021 |
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| 4 weeks (28 Days) |
| Little Rock |
| Arkansas |
| United States |
| Rogers | Arkansas | United States |
| Costa Mesa | California | United States |
| Glendale | California | United States |
| Irvine | California | United States |
| Lemon Grove | California | United States |
| Long Beach | California | United States |
| Oceanside | California | United States |
| Riverside | California | United States |
| Santa Ana | California | United States |
| Hallandale | Florida | United States |
| Hialeah | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Suwanee | Georgia | United States |
| Honolulu | Hawaii | United States |
| Las Vegas | Nevada | United States |
| Berlin | New Jersey | United States |
| Marlton | New Jersey | United States |
| Toms River | New Jersey | United States |
| Brooklyn | New York | United States |
| Staten Island | New York | United States |
| Centerville | Ohio | United States |
| Dayton | Ohio | United States |
| San Antonio | Texas | United States |
Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks
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| COMPLETED | Part A |
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| NOT COMPLETED |
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Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | 9 mg ITI-007 | 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks |
| BG001 | Placebo | Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| CMAI-C | 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. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C) | 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. | Intent-to-Treat Set (Study stopped for futility) | Posted | Least Squares Mean | Standard Error | score on a scale | 4 weeks (28 Days) |
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| Secondary | Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S) | 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). | Intent-to Treat Set | Posted | Least Squares Mean | Standard Error | score on a scale | 4 weeks (28 Days) |
|
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4 weeks of double blind treatment.
Safety Analysis Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 9 mg ITI-007 | 9 mg ITI-007 administered as a solid oral dose formulation once daily for 4 weeks | 0 | 86 | 2 | 86 | 13 | 86 |
| EG001 | Placebo | Placebo administered as a visually-matched solid oral dose formulation once daily for 4 weeks | 0 | 89 | 1 | 89 | 8 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Acarodermatitis | Infections and infestations | Systematic Assessment |
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| Ammonia Increased | Investigations | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ITI Clinical Trials | Intra-Cellular Therapies, Inc. | 646-440-9333 | ITCIClinicalTrials@itci-inc.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 23, 2018 | May 13, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000705749 | lumateperone |
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| Male |
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| Black or African American |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Multiple |
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| Unknown |
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| CMAI-C Non-Aggressive Agitated Behavior |
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| CMAI-C Verbally Agitated Behavior |
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| Verbally Agitated Behavior |
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