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临床试验/NCT05756270
NCT05756270已完成不适用

Clinical Applicability of Pseudo-continuous Arterial Spin Labeling as a Substitute for FDG-position Emission Tomography in MCI and SCD Patients

University of Milano Bicocca1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Correlation between brain hypoperfusion and brain hypometabolism at baseline

研究概览

简要总结

The goal of this observational study is to compare cerebral perfusion patterns with pseudo-continuous arterial spin labeling (pCASL) and brain metabolism patterns with fluorodeoxyglucose-position emission tomography (FDG-PET) in patients with mild cognitive impairment (MCI) and subjective cognitive decline (SCD). The main questions it aims to answer are:

  • Do pCASL sequences identify hypoperfusion patterns that correlate well with FDG-PET hypometabolic patterns?
  • Are there differences in this correlation in terms of cerebrospinal fluid (CSF) profiles?
  • Can hypoperfusion patterns in pCASL predict conversion to dementia? Participants will undergo brain 3 Tesla magnetic resonance imaging (MRI), FDG-PET, lumbal puncture and blood collection to analyze amyloid beta and tau, yearly detailed neuropsychological tests for three years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with mild cognitive impairment or subjective cognitive decline according to established criteria
  • Clinical Dementia Rating scale of 0 or 0.5
  • Signed informed consent before study entry

排除标准

  • Contraindication to brain MRI, FDG-PET or lumbar puncture
  • Secondary causes of cognitive decline
  • Known major neurological or psychiatric comorbidities
  • History of substance or alcohol abuse
  • Known causes of cerebral brain perfusion alterations
  • Enrollment in anti-amyloid or anti-tau drugs trials

结局指标

主要结局

Correlation between brain hypoperfusion and brain hypometabolism at baseline

时间窗: Baseline

The investigators will correlate cerebral perfusion indices and standardized uptake value ratios (SUVr) ratios for each pre-specified region of interest (ROI) within statistical parametric mapping (SPM) Automatic Anatomic Labeling (AAL), after coregistration on T1 sequences

Correlation between brain hypoperfusion and brain hypometabolism at baseline according to CSF profile

时间窗: Baseline

The investigators will correlate cerebral perfusion indices and SUVr for each pre-specified ROI (region of interest) within SPM Automatic Anatomic Labeling (AAL), after coregistration on T1 sequences. This analysis will be done within subgroups according to CSF status according to amyloid beta, phosphorylated tau and total tau.

次要结局

  • Correlations between brain hypoperfusion and CSF and blood biomarkers(Baseline)
  • Correlations between brain hypoperfusion and neuropsychological tests(Baseline, 1 year, 2 years)
  • Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia(1 year, 2 years)
  • Differences among brain hypoperfusion patterns according to amyloid and tau status(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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