Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type

• Status: Terminated
• Trial end date: 2016-03-18
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Aripiprazole

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)