TerminatedPhase 3Results posted

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

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

Lead sponsor

Intra-Cellular Therapies, Inc.

Asset

ITI-007

Listed sites

Recruiting sites

Enrollment

177

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•The Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDITI-007-201

NCT IDNCT02817906

Timeline

Milestones

Study first posted2016-06-29estimated

Study start2016-08-29actual

Primary completion2019-01-30actual

Study completion2019-01-30actual

Last update posted2021-06-29actual

Results first posted2021-06-29actual

Assets

Drug assets

ITI-007

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

4 endpoints

Primary/protocol endpoint

Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

Time frame:4 weeks (28 Days)

change from baseline, improvement

Primary/registry result

Change From Baseline in the Cohen-Mansfield Agitation Inventory - Community Version (CMAI-C)

Time frame:4 weeks (28 Days)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
9 mg ITI-007Aggressive Agitated Behaviorn=78 Participants	-1.0	0.37
Non-Aggressive Agitated Behaviorn=78 Participants	-4.1	0.72
Verbally Agitated Behaviorn=78 Participants	-2.9	0.49
PlaceboAggressive Agitated Behaviorn=84 Participants	-2.3	0.33
Non-Aggressive Agitated Behaviorn=84 Participants	-3.9	0.65
Verbally Agitated Behaviorn=84 Participants	-2.3	0.45

Secondary/protocol endpoint

Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)

Time frame:4 weeks (28 Days)

change from baseline, improvement

Secondary/registry result

Change From Baseline in the Clinical Global Impression Scale for Severity of Illness (CGI-S)

Time frame:4 weeks (28 Days)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
9 mg ITI-007CGI-S Aggressionn=78 Participants	-0.4	0.12
CGI-S Agitationn=78 Participants	-0.8	0.11
PlaceboCGI-S Aggressionn=84 Participants	-0.6	0.10
CGI-S Agitationn=84 Participants	-0.9	0.10

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.