JPRN-jRCT1031230530招募中Unknown
A tau PET study for non-AD tauopathies
Takano Harumasa0 个研究点目标入组 80 人开始时间: 2023年12月22日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patient group
- •(common part)
- •1) Persons who are 50 years of age or older at the time of obtaining consent regardless of gender
- •2) Currently attending our hospital or having participated in research, and falls under any of A, B, or C below.
- •3) There is a study partner who communicates with participants at least once a week and who serves as an information provider.
- •(Contact with research subjects may be face-to-face, by telephone, email, etc.).
- •4) Those who have blood or cerebrospinal fluid specimens in the NCNP biobank, or those who plan to collect specimens.
- •A. Progressive Supranclear Palsy (PSP)
- •a) Those who are clinically diagnosed with PSP according to the diagnostic criteria of the Basic Research Group in the Field of Neurodegenerative Diseases
- •B. Corticobasal Syndrome (CBS)
- •a) Those who are clinically diagnosed with CBS by the Basic Research Group in the Neurodegenerative Disease Area
- •C. Non-Alzheimer's MCI
- •a) 0.5 in comprehensive CDR
- •b) Amyloid PET is negative in past studies, etc.
- •Healthy subjects
- •1) Healthy subjects with normal cognitive function (MMSE 28 points or higher)
- •2) Must be 50 years of age or older at the time of obtaining consent. regardless of gender
- •3) Comprehensive CDR is 0
- •4) Agree to undergo all tests including MRI, amyloid PET, and tau PET
- •5) After fully understanding the research content, written consent of the individual's free will can be obtained.
- •6) Persons who have blood or cerebrospinal fluid specimens in the NCNP biobank or those who plan to collect specimens.
排除标准
- •1. Patients
- •1) Proven to have multiple cerebral infarctions, normal pressure hydrocephalus, brain tumors, epilepsy, subdural hematoma, multiple sclerosis, or head trauma with residual symptoms or brain structural abnormalities
- •2) Exhibiting local lesions on MRI, such as infections and cerebral infarctions, which could affect cognitive function. Asymptomatic deep small infarctions and mild white matter changes are deemed acceptable for inclusion, but atheromal thrombosis and cardiac embolism, infarction with lesions in the cerebral cortex, or severe diffuse white matter changes (Fazekas grades equal to or above 3) are excluded.
- •3) Possessing an implanted pacemaker, aneurysm clip, artificial inner ear, or other magnetic/electric conductive metals or being unable to undergo MRI because of claustrophobia
- •4) Having allergy to thioflavin derivatives
- •5) Having a history of major depressive disorder or bipolar disorder defined by Diagnostic Statistical Manual (DSM)-V within 1 year prior or schizophrenia as defined by DSM-5
- •6) Being comorbid with or having a history of alcohol/drug dependence as defined by DSM-V within past 2 years
- •7) Exhibiting psychiatric symptoms, excitement, or behavioral disturbance to a degree that would have hindered their ability to follow the research protocol within the preceding three months
- •8) Having serious systemic diseases or unstable diseases
- •9) Currently participating in a clinical interventional study/trial or a history of having participated in anti-amyloid trials
- •10) Other, when a patient is judged as unsuitable by the principal investigator or sub-principal investigator
- •2. Healthy volunteers
- •1) Being diagnosed with a specific neurodegenerative disease including the AD spectrum. Proven to have multiple cerebral infarctions, normal pressure hydrocephalus, epilepsy, subdural hematoma, multiple sclerosis, and head trauma, with residual symptoms or brain structural abnormalities.
- •2) Exhibiting local lesions on MRI, such as infections and cerebral infarctions, which could affect cognitive function. Asymptomatic deep small infarctions and mild white matter changes are deemed acceptable for inclusion, but atheromal thrombosis and cardiac embolism, infarction with lesions in the cerebral cortex, or severe diffuse white matter changes (Fazekas grades equal to or above 3) are excluded.
- •3) Possessing an implanted pacemaker, aneurysm clip, artificial inner ear, or other magnetic/electric conductive metals or being unable to undergo MRI because of claustrophobia
- •4) Having allergy to thioflavin derivatives
- •5) Having a history of major depressive disorder or bipolar disorder as defined by DSM-V within 1 year prior or schizophrenia as defined by DSM-5
- •6) Being co-morbid with or having a history of alcohol/drug dependence as defined by DSM-V within 2 years prior
- •7) Having serious systemic diseases or unstable diseases
- •8) Others, judged to be unsuitable by principal investigator (PI) and co-PI.
研究者
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