2023-503538-37-00招募中2 期
ASSESSMENT OF THE BRAIN DEPOSIT OF TAU 4R DETECTED BY BRAIN PET WITH 18F-PI2620 IN PROGRESSIVE SUPRANUCLEAR PALSY COMPARED TO CONTROLS WITHOUT NEURODEGENERATIVE TAUOPATHY 4R: A CLINICAL TRIAL
University Clinic Of Navarra2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2023年8月7日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer
研究概览
简要总结
To compare the brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer in patients with PSP compared to controls.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Subjects from one of the following two groups: a) Patients aged between 40 and 79 years, with a clinical diagnosis of different variants of PSP. Clinical diagnosis will be based on the MDS-PSP criteria for PSP subtypes (Höglinger et al., 2017). In addition, we will apply the recently proposed Multiple Allocations eXtinction (MAX) rules to approach ambiguous multiple allocations (Grimm et al., 2019). b) Control group: b.1.. Patients aged 40 to 79 years, with a clinical diagnosis of PD according to the UK Parkinson's Disease Society Brain Bank Diagnostic Criteria (Hughes et al., 1992) and normal cognitive status (MoCA>24). b.2.. Healthy subjects (male or female) aged 40 to 79 years, with normal neurological examination and normal cognitive status (MoCA>24).
- •The subject, or their representative, has given their consent to participate in the study.
- •The subject must, in the opinion of the investigator, be able to meet all the requirements of the clinical trial.
排除标准
- •Patients with evidence of relevant structural brain abnormalities or significant leukoencephalopathy on magnetic resonance imaging (MRI) (Fazekas score ≥3 or a score of ≥3 on the age-related white matter changes Rating Scale) (Wahlund et al., 2001).
- •Patients with PD with cognitive impairment (MoCA<24).
- •Pregnant, breastfeeding or childbearing women who are not going to use contraception.
结局指标
主要结局
Brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer
Brain deposit of tau 4R protein by means of the PET-Tau imaging study using the 18F-PI2620 radiotracer
次要结局
- Pattern of glucose metabolism by PET-FDG
- Motor (rigidity, bradykinesia, falls, dysarthria, etc.) and non-motor (depression, apathy, cognitive impairment) symptoms
研究者
UCEC
Scientific
University Clinic Of Navarra
研究点 (2)
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