NL-OMON50757已完成2 期
Tau Imaging in Tauopathies; Alzheimer's disease and Non-AD dementias - TITA
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria: , - At least 35 years of age
- •- Subjects must, in the opinion of the principal investigator/attending
- •neurologist, be able to tolerate the [18F]AV1451 PET scan procedures and be
- •competent to make a well informed decision to participate in this study..,
- •Additional inclusion criteria per diagnostic group:, For probable AD dementia
- •- A diagnosis of probable AD with at least intermediate likelihood according to
- •recently proposed NIA-AA criteria27. This will be determined using PET and/or
- •CSF evidence of A* deposition., For *MCI due to AD* patients;
- •- Patients must meet clinical criteria for MCI25, and;
- •- present with positive A* biomarkers on PET and/or CSF., For DLB patients;
- •- At least 50 years of age
- •- Patients must be included in the DEvELOP (protocol number 15/548)
- •- Subjects must, in the opinion of the principal investigator/attending
- •neurologist, be able to tolerate the [18F] FDG PET scan procedures, For
- •- No objective evidence of cognitive impairment as assessed by a
- •multidisciplinary specialist team;
- •- normal MRI;
排除标准
- •No MRI available or possible
- •Abnormalities on MRI which may interfere with PET image assessment:
- •Is or may become pregnant in the first 24h after the PET scan
- •Relevant history of drug allergy or hypersensitivity
- •Has ever recieved a tau and/or amyloid-beta targetting agent
- •Has been injected with a previously administered radiopharmaceutical within 6
- •terminal half-lives OR the total yearly radiation exposure exceeds 10 mSv;
- •Has a history of moderate or severe traumatic brain injury (TBI).
研究者
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