Trial · NCT02817906

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

NCT02817906, Phase 3, Terminated, Intra-Cellular Therapies, Inc.; results first posted 2021-06-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease. Trials, record NCT02817906. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02817906

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ITI-007 for the Treatment of Agitation in Patients With Dementia, Including Alzheimer's Disease
NCT number: NCT02817906
Status: Terminated
Phases: Phase 3
Enrollment: 177 participants, actual
Lead sponsor: Intra-Cellular Therapies, Inc.
Conditions: Agitation in Dementia, Including Alzheimer's Disease
Interventions: ITI-007, Placebo
First posted: 2016-06-29
Last updated: 2021-06-29
Results first posted: 2021-06-29
Limitations and caveats: 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.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	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.
Secondary	Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	4 weeks (28 Days)	Intent-to-Treat Set (Study stopped for futility)	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	4 weeks (28 Days)	Intent-to Treat Set	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	9 mg ITI-007	Aggressive Agitated Behavior	-1.0	Standard Error 0.37	score on a scale
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	Placebo	Aggressive Agitated Behavior	-2.3	Standard Error 0.33	score on a scale
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	9 mg ITI-007	Non-Aggressive Agitated Behavior	-4.1	Standard Error 0.72	score on a scale
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	Placebo	Non-Aggressive Agitated Behavior	-3.9	Standard Error 0.65	score on a scale
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	9 mg ITI-007	Verbally Agitated Behavior	-2.9	Standard Error 0.49	score on a scale
Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)	Placebo	Verbally Agitated Behavior	-2.3	Standard Error 0.45	score on a scale
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	9 mg ITI-007	CGI-S Aggression	-0.4	Standard Error 0.12	score on a scale
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	Placebo	CGI-S Aggression	-0.6	Standard Error 0.10	score on a scale
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	9 mg ITI-007	CGI-S Agitation	-0.8	Standard Error 0.11	score on a scale
Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)	Placebo	CGI-S Agitation	-0.9	Standard Error 0.10	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	ITI-007 9 mg	86
Overall Study	STARTED	Placebo	89
Overall Study	COMPLETED	ITI-007 9 mg	70
Overall Study	COMPLETED	Placebo	84
Overall Study	NOT COMPLETED	ITI-007 9 mg	16
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Dizziness	Nervous system disorders	9 mg ITI-007	4	86
other	Dizziness	Nervous system disorders	Placebo	0	89
other	Fall	Injury, poisoning and procedural complications	9 mg ITI-007	4	86
other	Fall	Injury, poisoning and procedural complications	Placebo	1	89
other	Nausea	Gastrointestinal disorders	9 mg ITI-007	3	86
other	Nausea	Gastrointestinal disorders	Placebo	0	89
other	Vomiting	Gastrointestinal disorders	9 mg ITI-007	2	86
other	Vomiting	Gastrointestinal disorders	Placebo	0	89
other	Constipation	Gastrointestinal disorders	9 mg ITI-007	2	86
other	Constipation	Gastrointestinal disorders	Placebo	0	89

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	9 mg ITI-007	0	86
Total, all-cause mortality	Placebo	0	89
Total, other adverse events	9 mg ITI-007	13	86
Total, other adverse events	Placebo	8	89
Total, serious adverse events	9 mg ITI-007	2	86
Total, serious adverse events	Placebo	1	89

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
9 mg ITI-007 vs Placebo: deaths from any cause	Trial comparisons
9 mg ITI-007 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02817906

GET https://conductscience.org/api/trials/v1/NCT02817906/events?page=2

API reference For AI assistants