JPRN-jRCTs031220123招募中未知
Investigation for efficacy and safety of alpha-synuclein PET ligand [18F] C05-05
Endo Hironobu0 个研究点目标入组 91 人开始时间: 2022年6月9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
- 91
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
- •(A) Brain dynamics evaluation
- •Patients (20 patients with dementia with Lewy bodies, 20 patients with Parkinsons disease, 10 patients with multiple system atrophy, 5 patients with progressive supranuclear palsy, 5 patients with corticobasal syndrome, and 5 patients with Alzheimers disease)
- •(1)Patients who are 20 years old or older at the time of consent acquisition.
- •(2)Patients whom a potential substitute can accompany on the day of participation in the study at QST
- •(3)Patients with dementia with Lewy bodies and Parkinsons disease: Patients who meet the UKPDSBB clinical diagnostic criteria or the diagnostic criteria of McKeith et al.
- •(4)Patients with multiple system atrophy: Patients who meet Gilmans clinical diagnosis criteria.
- •(5)patients with progressive supranuclear palsy: Patients who meet the diagnostic criteria of Hoeglinger et al and Kanazawa et al.
- •(6)patients with corticobasal syndrome: Patients who meet the clinical diagnostic criteria of Mayo and/or Cambridge.
- •(7)patients with Alzheimers disease: Patients who meet the NINCDS-ADRDA diagnostic criteria.
- •Healthy subjects (20 healthy subjects)
- •(1)Healthy adults who have been determined to be eligible for this study by the principal investigator or sub-investigator.
- •(2)Those who are 20 years of age or older at the time of obtaining consent.
- •(B) Whole body dynamic evaluation (6 Healthy subjects; 3 male and 3 female)
- •(1)Healthy adults who are judged to be eligible for this study by a medical examination by the principal investigator or sub-investigator.
- •(2)Healthy adults who are 50 years of age or older at the time consent is obtained.
排除标准
- •(1) Patients with a history of or complications from organic brain disease (for example, disorders of consciousness, head trauma requiring hospitalization, evident cerebral infarction, or cerebral hemorrhage).
- •(2) Patients with substance-related disorders (for example, drug dependence).
- •(3) Those who have complications from serious diseases or those who have a history of such diseases, judged by the principal investigator or sub-investigator to be inappropriate for this study.
- •(4) Those who have magnetic metals in their body (for example, tattoos, tattoos including art makeup, pacemakers) (for brain dynamics evaluation only).
- •(5) Persons with intense claustrophobia.
- •(6) Those who are pregnant or may be pregnant, and those who are breast-feeding.
- •(7) Those who are allergic to local anesthetics and blood coagulation inhibitors. (Brain dynamics evaluation only)
- •(8) Those who are taking the anticoagulant medication. (Brain dynamics evaluation only)
- •(9) Others judged by the principal investigator or sub-investigator to be inappropriate as research subjects.
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