Alzheimer's Disease, Dementia
Conditions
Keywords
Acute agitation in patients diagnosed with Dementia
Brief summary
The purpose of this trial is to test the safety & tolerability of intramuscular aripiprazole in acutely agitated patients diagnosed with Dementia.
Interventions
DRUGAripiprazole
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.
DRUGPlacebo
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.
Sponsors
Otsuka America Pharmaceutical
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| safety assessments | — |
Countries
United States
Outcome results
None listed