A Community-Based Screening Program to Identify, Using Blood-Based Biomarkers, Individuals With or Without Alzheimer's Disease Symptoms Who Are at High Risk for Brain Amyloid Pathology

Eisai Limited3 个研究点分布在 1 个国家目标入组 2,000 人2023年9月12日

适应症Alzheimer's Disease

干预措施No Intervention

概览

阶段: 不适用
干预措施: No Intervention
疾病 / 适应症: Alzheimer's Disease
发起方: Eisai Limited
入组人数: 2000
试验地点: 3
主要终点: Number of Participants With Low, Medium, and High Amyloid Pathology
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The primary purpose of this study is to identify participants with or without symptoms of Alzheimer's Disease (AD) that are at high risk for brain amyloid pathology using blood-based biomarkers.

注册库

clinicaltrials.gov

开始日期

2023年9月12日

结束日期

2028年3月31日

最后更新

上个月

研究类型

Observational

性别

All

研究者

发起方

Eisai Limited

责任方

Sponsor

入排标准

入选标准

•Male or female, age 50 to 80 years inclusive, at the time of informed consent
•\- Those 50 to 64 years of age must have 1 of the following risk factors confirmed prior to blood sample collection:
•First degree relative with dementia onset before age 75,
•Known before screening to have at least 1 Apolipoprotein E4 (APOE4) allele, or
•Known before screening to have elevated brain amyloid according to previous positron emission tomography (PET), cerebrospinal fluid (CSF), or blood testing
•Provide written informed consent
•Willing and able to comply with all aspects of the protocol
•Willing to be referred to a clinical site if the assessment results meet the criteria

排除标准

•Known uncontrolled medical conditions (example, cardiac, respiratory, gastrointestinal, psychiatric, renal disease, malignant neoplasm)
•Participation in an interventional clinical trial study at the time of consent