Investigation for efficacy and safety of alpha-synuclein PET ligand [18F] SPAL-T-06

Endo Hironobu0 个研究点目标入组 30 人开始时间: 2021年7月2日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•(A) Brain dynamics evaluation
•Patients (6 patients with dementia with Lewy bodies, 6 patients with Parkinson's disease, and 6 patients with multiple system atrophy)
•(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 NIRS.
•(3) Patients with dementia with Lewy bodies and Parkinson's disease: Patients who meet the UK Parkinson's disease society brain bank clinical diagnostic criteria or the diagnostic criteria of McKeith et al.
•(4) Patients with multiple system atrophy: Patients who meet Gilman's clinical diagnosis criteria for MSA.
•Healthy subjects (6 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.

•(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.

发起方

Endo Hironobu