← Trials/Trial dossier/NCT00095719

CompletedPhase 3

Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

A Safety & Tolerability Study of Intramuscular Aripiprazole in Acutely Agitated Patients Diagnosed With Dementia

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Asset

Aripiprazole

Listed sites

Recruiting sites

Enrollment

125

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•Tolerability

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 IDCN138-131

NCT IDNCT00095719

Timeline

Milestones

Study start2003-12 (month precision)

Study first posted2004-11-09estimated

Primary completion2005-03actual (month precision)

Study completion2005-03actual (month precision)

Last update posted2013-11-11estimated

Assets

Drug assets

Aripiprazole

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age95 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Acute agitation in Patients with a DSM-IV diagnosis of Alzheimer's, vascular or mixed Dementia

Exclusion criteria

•Current DSM-IV Axis 1 diagnosis other than Alzheimer's, vascular or mixed Dementia.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

tolerability

descriptive

Secondary/protocol endpoint

safety assessments

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.