NCT00095719

Brief Summary

The purpose of this trial is to test the safety \& tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

November 9, 2004

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

November 11, 2013

Status Verified

August 1, 2008

Enrollment Period

1.2 years

First QC Date

November 9, 2004

Last Update Submit

November 7, 2013

Conditions

DementiaAlzheimer's Disease

Keywords

Acute agitation in patients diagnosed with Dementia

Outcome Measures

Primary Outcomes (1)

  • tolerability

Secondary Outcomes (1)

  • safety assessments

Study Arms (2)

A1

ACTIVE COMPARATOR
Drug: Aripiprazole

B1

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AripiprazoleDRUG

IM Solution, IM, Cohort 1 - 2.5mg (.33cc) maximum dose 5.0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 5.0mg (.67cc) maximum dose 10 mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 10 mg (1.3cc) or 5.0 mg (.67cc) maximum dose 15mg; 1 injection, 24 hour observation for all cohorts.

Also known as: Abilify
A1
PlaceboDRUG

IM Solution, IM, Cohort 1 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 2 - 0mg; 2 injections 2nd injection 2 hours after first; Cohort 3 - 0mg; 1 injection, 24 hour observation for all cohorts.

B1

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Local Institution

Santa Ana, California, United States

Location

Local Institution

Hamden, Connecticut, United States

Location

Local Institution

Hialeah, Florida, United States

Location

Local Institution

Miami, Florida, United States

Location

Local Institution

North Miami, Florida, United States

Location

Local Institution

Indianapolis, Indiana, United States

Location

Local Institution

New York, New York, United States

Location

Local Institution

Staten Island, New York, United States

Location

Local Institution

Dayton, Ohio, United States

Location

Local Institution

Oklahoma City, Oklahoma, United States

Location

Local Institution

Tulsa, Oklahoma, United States

Location

Local Institution

Hershey, Pennsylvania, United States

Location

Local Institution

Austin, Texas, United States

Location

Local Institution

Midvale, Utah, United States

Location

MeSH Terms

Conditions

DementiaAlzheimer Disease

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 9, 2004

Study Start

December 1, 2003

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 11, 2013

Record last verified: 2008-08

Locations

US(14)