NCT04482660Enrolling By Invitation不适用
Characterization of Cerebral Tau Aggregates With 18F-RO6958948 PET in the ALFA Population
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年3月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Prevalence of cerebral tau positivity
研究概览
简要总结
This study will characterize tau tracer retention by Positron Emission Tomography (PET) as a function of amyloid levels transversally and longitudinally.
详细描述
CROSS-SECTIONAL OBJECTIVES
- To measure 18F-RO6958948 retention in selected participants of ALFA-related studies as a function of amyloid levels.
- To study the relation between 18F-RO6958948 retention and amyloid levels.
- To characterize imaging correlates as a function of tau and amyloid levels.
- To study the role of tau retention on cognitive performance.
- To define predictors of tau retention.
LONGITUDINAL OBJECTIVES
- To measure tau accumulation and spreading in participants of the ALFA-related studies of BBRC as a function of baseline amyloid levels.
- To study the dynamic relation between tau spreading and amyloid levels longitudinally.
- To define predictors of tau spreading.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To sign the study informed consent form approved by the corresponding authorities.
- •Men and women that have participated in a BBRC-sponsored study, including the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the ALFA cognition study (ALFAcognition/BBRC2017) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
- •Participants with an available cerebral MRI within the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion.
- •Known cognitive status based on the cognitive workup of the BBRC-sponsored studies specified above. Cognitive status should have been determined within the last 12 months.
- •Known AB and tau status.
- •Good knowledge of the language and being literate.
- •Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.
排除标准
- •Presence of clinically relevant psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria: major depressive disorder, generalized anxiety disorder, schizophrenia and bipolar disorder, as assessed in the BBRC-sponsored studies specified above.
- •Participants with visual and/or hearing impairment.
- •History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above.
- •Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI.
- •Previous participation in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or administration of a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study.
- •Clinically relevant renal or hepatic insufficiency.
- •Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
- •Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above.
- •Previous intolerance to PET studies or known hypersensitivity to 18F-RO
- •Being pregnant or breast-feeding.
结局指标
主要结局
Prevalence of cerebral tau positivity
时间窗: at inclusion
Prevalence of cerebral tau positivity assessed by 18F-RO6958948 PET
tau accumulation and spreading
时间窗: 2 years
To predictors of tau spreading
次要结局
未报告次要终点
研究者
研究点 (2)
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