JPRN-jRCTs031180225招募中未知
Elucidation of the pathophysiological mechanism of dementia and clinical research for creation of drug discovery targets
Ito Daisuke0 个研究点目标入组 500 人开始时间: 2019年3月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 500
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Selection criteria common to all subjects
- •1. The subject fully understands the contents of the research and written consent is obtained from the subject. If the attending physician considers that the subject's consent ability is not sufficient, written consent is obtained from the substitute.
- •2. The following healthy volunteers and patients who speak Japanese as their mother language, have normal writing abilities, and have no audio-visual disorders. However, subjects who are unable to write do to neurodegenerative diseases are allowed to participate in the research.
- •Healthy subjects, patients with Alzheimer's disease (AD), mild cognitive impairment (MCI), frontal temporal lobe degeneration (FTLD), head trauma, Parkinson's disease or Parkinson's syndrome, senile psychosis, Lewy body Dementia (DLB)
- •3. Subjects who have been judged by the doctor that a study partner is necessary, must have a study partner. The study partner must satisfy the following conditions. The study partner is physically and mentally healthy, has contact with the subject for more than 10 hours a week, and can accompany all examinations during the observation period, etc.
- •4. The subject's medical history, physical examination results, general blood test findings do not interfere with the subject's participation in the research.
- •5. The subject carries no severe diseases which may cause interruption during the research or which may need hospital treatment.
- •6. Women participating in the research are not pregnant or nursing.
- •7. The subject has the intention and ability to participate in the research for 3 years.
- •8. The subject agrees to receive MRI, tau PET, amyloid PET, and the blood test.
- •9. When taking restricted concomitant medicine, the dosage regimen / dose must be stable for more than 12 weeks before screening.
排除标准
- •1. When an infection, a cerebral infarction or a local lesion, which affects the cognitive function, is found by MRI during screening. Small infarcts in the deep area and diffuse changes in the white matter are allowed, however those occurring in specific sites which affect the cognitive function, as well as principle cortical infarctions are excluded.
- •2. When there is a problem in taking an MRI imaging, due to pacemaker, aneurysm clip, artificial valve, cochlear implant or other magnetic or electrically conductive metal, or claustrophobia.
- •3. The subject has psychiatric symptoms, excitability, behavior abnormalities within the past 3 months, which make it difficult to follow the protocol.
- •4. The subject suffers from a severe systemic disease or an unstable disease.
- •5. The subject has syphilis, or the subject's thyroid function affects the cognitive function.
- •6. When performing lumbar puncture, if the subject takes antiplatelet medications, the withdrawal period before the examination should be considered.
- •7. The subject is not participating in any treatment drug trials.
- •8. The subject is planning to participate in therapeutic clinical trials of Alzheimer's disease during the 3-year research period.
- •9. When taking a prohibited concomitant medicine such as warfarin.
- •10. The subject has Huntington's disease, multiple cerebral infarction, normal pressure hydrocephalus, brain tumor, epilepsy, paroxysmal disease, subdural hematoma, multiple sclerosis.
- •11. When there is a history of juvenile onset normal schizophrenia.
- •12. It is judged by the attending physician that the subject's participation is not appropriate.
研究者
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