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临床试验/NCT04992975
NCT04992975招募中不适用

Brain Iron Toxicity and Neurodegeneration - An Ultrahigh Field (7T) MRI Study

Nottingham University Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year

研究概览

简要总结

A longitudinal observational neuroimaging study of individuals with Early Onset Alzheimer's disease during the prodromal phase, and matched control group - Ultrahigh Field MRI study at 7T

详细描述

This study aims to determine whether high resolution MRI at 7T and Quantitative Susceptibility Mapping (QSM) can demonstrate a specific pattern of iron overload in strategically important areas of brain as a sensitive marker of pathological Alzheimer's disease i.e. patients with subjective or mild cognitive impairment associated with Amyloid or tau pathological state in the cerebrospinal fluid.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to provide informed consent
  • Patients with pathological diagnosis of Alzheimer's disease according to the National Institute on Aging and Alzheimer's Association, NIA-AA, criteria (Alzheimer's group) or cognitively normal individuals within 1.5 standard deviation of normal in all tests (control group)

排除标准

  • Lack of mental capacity to consent to study involvement
  • Not speaking English before age 5 years
  • Learning disability
  • Schizophrenia
  • Substance misuse
  • Implanted devices not certified as compatible with ultra-high field MRI (e.g. cardiac pacemaker)
  • Pregnancy

结局指标

主要结局

Quantitative Susceptibility Mapping, QSM (from 7T MRI data) to hippocampal subfield volume loss at 1 year

时间窗: one year

Relationship between QSM at recruitment and to hippocampal subfield volume (QSM and hippocampal subfield volume are obtained from 7T MRI Susceptibility Weighted and T1 Weighted images)

次要结局

  • neuropsychological measures in relation to QSM and volume loss in hippocampal subfields(one year)
  • cross-sectional and longitudinal changes in QSM in the hippocampal subfields(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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