2024-519961-23-00招募中4 期
Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and of glucose metabolism with 18F-FDG PET in individuals enrolled in the ALFA project
Barcelonabeta Brain Research Center1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.
研究概览
简要总结
To determine the prevalence and progression of positive 18F-Flutemetamol scans in individuals recruited in the ALFA project
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 enrolled in the STUDY 45-65 FPM/2012
- •Participants with a cerebral MRI (magnetic resonance imaging) not suggestive of radiological incidental findings constituting an exclusion criterion
- •Cognition within psychometric normal ranges: MMSE (Mini Mental State Examination ≥26 and Verbal Semantic Fluency (animals) ≥12) at baseline
- •Score of 0 in the CDR scale (Clinical Dementia Rating) at baseline
- •Good knowledge of Spanish or Catalan and being literate
- •Female participants should be post-menopausal or present a negative pregnancy test at the moment of PET realization
排除标准
- •To present cognitive impairment at baseline
- •Active drug or alcohol abuse
- •Presence of a pacemaker, aneurysm graft, artificial heart valves, auditory implants, cerebral shunts, metal fragments, or strange objects in the eyes, skin, or body that may contraindicate magnetic resonance imaging
- •Previous intolerance to PET studies or known hypersensitivity to 18F-Flutemetamol or 18F-FDG
- •Being pregnant or breast-feeding
- •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
- •Individuals with visual and/or hearing impairment
- •History of encephalitis, ictus, or seizures excluding feverish convulsions during childhood
- •Severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumour (metastasis/brain cancer) as verified by magnetic resonance imaging (MRI)
- •Any contraindication to MRI acquisition, (i.e., metal implants) or phobia to performing the scan as determined by the onsite physician
- •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 significant condition that may jeopardize the study or be dangerous for the participant
结局指标
主要结局
Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.
Participants with a mean cortex activity SUVr (cerebellar cortex) over 1.56 in 18F-Flutemetamol PET will be classified as positive and, otherwise, as negative for cerebral amyloid deposition. Prevalence of positive 18F-Flutemetamol PET will be determined by age, sex, APOE genotype, and familiar history of AD.
次要结局
未报告次要终点
研究者
Oriol Grau
Scientific
Barcelonabeta Brain Research Center
研究点 (1)
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