Clinical trial NCT02168920: Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole in the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Agitation Associated With Dementia of the Alzheimer's Type
Keywords: Alzeheimer
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-06-20
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: CMAI
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Clinical Global Impression of Severity （CGI-S）
timeFrame: Baseline, 10 weeks
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 10 Weeks
Other outcomes:
Locations:
city: Kanto Region
country: Japan
Study officials:
References: