EUCTR2019-004290-84-ES进行中（未招募）1 期
Characterization of cerebral tau aggregates with 18F-RO6958948 PET in the ALFA population.
BarcelonaBeta Brain Research Center0 个研究点目标入组 100 人开始时间: 2020年5月10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
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signature of the study informed consent form approved by the corresponding authorities.
- •2. 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 ALFAcognition study (ALFAcognition/BBRC2017) or the Barcelona?eta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018).
- •3. Participants with an available cerebral MRI (magnetic resonance imaging) in the last 12 months not suggestive of radiological incidental findings constituting an exclusion criterion.
- •4. 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.
- •5. Known A? and tau status.
- •6. Good knowledge of the language and being literate.
- •7. Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET acquisition.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. 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.
- •2. Individuals with visual and/or hearing impairment.
- •3. History of encephalitis, ictus or seizures excluding feverish convulsions during childhood, as assessed in the BBRC-sponsored studies specified above.
- •4. Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by MRI.
- •5. 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.
- •6. Clinically relevant renal or hepatic insufficiency.
- •7. Any other clinically important condition that may jeopardize the study or be dangerous for the participant.
- •8. Active drug or alcohol abuse, as assessed in the BBRC-sponsored studies specified above.
- •9. Previous intolerance to PET studies or known hypersensitivity to 18F-RO6958948.
- •10. Being pregnant or breast-feeding.
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