CTIS2023-508718-40-00进行中（未招募）1 期
Quantification tools for a novel tau PET marker in a rare neurological disease: 18F-PI-2620 in progressive supranuclear palsy
Fundacio De Recerca Clinic Barcelona-Institut D’investigacions Biomediques August Pi I Sunyer0 个研究点目标入组 66 人开始时间: 2023年10月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patients of both sexes aged between 40 and 80 years., The subject must be able to comply with the protocols and procedures necessary for the development of the clinical trial., Consent of the subject or his/her legal representative to voluntarily participate in the study by signing the informed consent., In women, postmenopausal status (one year without menstruation without other medical causes) or negative pregnancy test. Subjects (women and male partners of participants) of childbearing age must agree to a commitment to practice sexual abstinence or use highly effective contraceptive methods (hormonal contraceptives that inhibit ovulation, IUDs, surgical sterilization) from their inclusion in the study until one month after the PET scan., Magnetic resonance imaging (MRI) study of the brain to rule out any other type of relevant neurological pathology., PSP population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Höglinger et al. 2017), Parkinson population: Have a clinical diagnosis of soPSP or probable PSP according to current diagnostic criteria (Postuma et .a, 2015), Control population: Absence of clinical history of neuropsychiatric diseases.
排除标准
- •Diagnosis of relevant central nervous system disease such as Huntington's disease, normotensive hydrocephalus, cerebrovascular disease, frontotemporal dementia, Alzheimer's disease, history of major or recurrent head trauma, history of epilepsy or seizures (except febrile seizures in childhood without antiepileptic medication at present)., Legal incapacity and/or circumstances that prevent the subject or his/her legal representatives from understanding the nature, objectives and possible consequences of the trial., Treatment with any other investigational medicinal products within 30 days prior to inclusion., PSP population: Diagnosis or suspicion of any Parkinsonian syndrome other than PSP such as idiopathic Parkinson's disease, pharmacological parkinsonism, essential tremor, primary dystonias, or any other cause that may produce symptoms similar to those of Parkinson's disease., Presence of terminal illnesses or illnesses that may put the patient's health at risk from participating in the study or influencing the results of the study or the patient's ability to participate in the study., Abuse of alcohol or other legal or illegal drugs (except nicotine)., Pregnancy., Known allergy to PI-2620 or any of the other components of the radiopharmaceutical., Any contraindication or impediment to the performance of the PET/CT study with PI-2620., Subjects who are not able to understand and/or comply with the necessary guidelines for the conduct of the trial (e.g.: interrogation, physical examination, lumbar puncture, attending visits, etc.) and that they do not have responsible companions who understand and commit to comply with these guidelines., Subjects who do not cooperate or are unable to comply with the procedures required for this clinical trial, such as (but not limited to): social disorders that anticipate an obvious lack of cooperation, psychopathy, drug or alcohol abuse., Subjects or their legal representatives who do not sign the informed consent.
研究者
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