Agitation Associated With Dementia of the Alzheimer's Type
Conditions
Keywords
Alzeheimer
Brief summary
To evaluate the efficacy (based on mean change in Cohen-Mansfield Agitation Inventory \[CMAI\] total score from baseline as the primary efficacy variable), dose-response, and safety of aripiprazole at 2, 3, and 6 mg/day in comparison with placebo in patients with agitation associated with Alzheimer's type dementia
Detailed description
This trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparison trial to assess the efficacy and safety of aripiprazole in patients with agitation associated with Alzheimer's type dementia. Screening period is 4 weeks. Patients are randomly assigned to one of 4 groups, and treatment period is 10 weeks. Period of post-treatment observation is 30 days.
Interventions
DRUG2 mg/day
Once daily for 10 weeks
DRUG3 mg/day
Once daily for 10 weeks
DRUG6 mg/day
Once daily for 10 weeks
DRUGPlacebo (0 mg/day)
Once daily for 10 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible). * Patients who satisfy both of the following diagnostic criteria: * Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to Diagnostic and Statistical Manual of mental disorders (DSM-5) * Diagnosis of probable Alzheimer's disease according to National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) * Hospitalized patients or care facility patients * Patients with an Mini-Mental State Examination (MMSE) score of 1 to 22
Exclusion criteria
* Patients with complications of dementia or memory impairment other than Alzheimer's type dementia * Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher * Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances * Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke * Patients with heart failure classified as New York Heart Asscoiation (NYHA） III or IV * Patients who require drug therapy for arrhythmia or ischemic heart disease * Body weight of less than 30 kg * Patients with a high risk of suicide * Patients with a complication or history of seizure disorder * Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis * Patients with thyroid disease (except if the disease has been stabilized with drug therapy for 3 months or longer prior to time of informed consent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMAI | Baseline, 10 weeks | Change from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Severity （CGI-S） | Baseline, 10 weeks | Change from baseline |
| Clinical Global Impression-Improvement (CGI-I) | 10 Weeks | Score after 10 weeks |
Countries
Japan
Outcome results
None listed