JPRN-jRCT2071220042进行中（未招募）2 期
A Phase II Multi-Center, Placebo-Controlled, Randomized, Double Blind, Parallel Group Study of NTPI in Patients with Behavioral and Psychological Symptoms Associated with Alzheimer's Disease.
Toyama Ikuo0 个研究点目标入组 90 人开始时间: 2022年8月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 65age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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