NCT03846232已完成不适用
T1rho: Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Detection of abnormal cerebral protein levels
研究概览
简要总结
The main goal of the T1rho/BBRC2017 study is to assess the capability of the MRI sequences T1rho + multicomponent T2 relaxation analysis of detecting abnormal cerebral protein deposition in AD patients in comparison with an age-matched cognitively healthy control group. Both the AD and control groups will had previously undergone amyloid PET imaging to confirm/discard cerebral proteinopathy in the context of other research studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 60 years
- •Informed, written consent form
- •To fully satisfy the criteria for one of the two following 2 groups:
- •for the AD group:
- •Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers): Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 27 (included).
- •Documented positive visual read (as per EMA-approved procedures for each respective tracer) of an amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD in the last 24 months.
- •Lumbar puncture with core AD CSF biomarkers available in the last 24 months.
- •For the cognitively health group:
- •Normal cognition as defined by the ALFA study cognitive workup (Molinuevo et al. 2016).
- •CONFIDENTIAL 17
- •[18F]-Flutemetamol PET scan performed in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study in the last 24 months.
- •Lumbar puncture with core AD CSF biomarkers preferably available in the last 24 months.
排除标准
- •Past or present history of major brain disorders other than MCI or AD.
- •Contraindication to MRI scanning or conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- •Participation in a clinical trial for a disease modifying drug for AD.
- •Hypoperfusion pattern not consistent with AD diagnosis, as assessed by ASL.
结局指标
主要结局
Detection of abnormal cerebral protein levels
时间窗: at inclusion
Discriminant capacity to detect abnormal cerebral protein levels in 3 age-matched groups: cognitively normal subjects without (CN) and with abnormal biomarker levels (PreAD), and Alzheimer Disease patients (AD).
次要结局
未报告次要终点
研究者
研究点 (1)
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