Aripiprazole for the Treatment of Patients With Agitation Associated With Dementia of the Alzheimer's Type
- Conditions
- Agitation Associated With Dementia of the Alzheimer's Type
- Registration Number
- JPRN-jRCT2080222527
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 880
1. Patients whose legal representatives can provide informed consent (Informed consent from the patients where possible).
2. Patients who satisfy both of the following diagnostic criteria:
- Diagnosis of major neurocognitive disorder due to Alzheimer's disease according to DSM-5
- Diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA
3. Hospitalized patients or care facility patients
4. Patients with an MMSE score of 1 to 22
1. Patients with complications of dementia or memory impairment other than Alzheimer's type dementia
2. Dementia patients with a Modified Hachinski Ischemic Score of 5 or higher
3. Patients with psychological symptoms or behavioral disorders that are clearly due to other medical conditions or substances
4. Patients with a complication or history of stroke or transient ischemic attack, except for asymptomatic stroke
5. Patients with heart failure classified as NYHA III or IV
6. Patients who require drug therapy for arrhythmia or ischemic heart disease
7. Body weight of less than 30 kg
8. Patients with a high risk of suicide
9. Patients with a complication or history of seizure disorder
10. Patients with a complication or history of neuroleptic malignant syndrome, tardive dyskinesia, paralytic ileus, or rhabdomyolysis
11. 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method