A Phase II Study of NTPI in Patients with Behavioral and Psychological Symptoms Associated with Alzheimer's Disease.
- Conditions
- Japanese patients with behavioral and psychological symptoms associated with Alzheimer's disease
- Registration Number
- JPRN-jRCT2071220042
- Lead Sponsor
- Toyama Ikuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1) Patients who have received sufficient explanation about this clinical trial, and obtained written consent of their agent and themselves.
2) Patients aged between 65 and 85 at the time of consent acquisition.
3) Patients fulfilled the criteria for Probable AD dementia of the NIA-AA diagnostic guidelines for Alzheimer's disease.
4) Patients with baseline MMSE score ranged from 10 to 20.
5) Patients with baseline NPI total score of 20 or more.
6) Patients judged to require drug therapy for behavioral and psychological symptoms associated with Alzheimer's disease.
1) Patients with dementia other than Alzheimer's disease.
2) Patients with behavioral and psychological symptoms induced by other diseases or drug.
3) Patients with alcohol or drug dependency, or having a medical history of them.
4) Patients with convulsive and/or epileptic seizure, or having a medical history of them.
5) Patients with thyroid disease.
6) Patients treated antipsychotics or psychostimulants for behavioral and psychological symptoms associated with Alzheimer's disease within 1 month before the day of consent acquisition.
7) Patients treated any therapy such as electroconvulsive therapy, high-intensity phototherapy or transcranial magnetic stimulation, within 3 months before the day of consent acquisition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method