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临床试验/NCT03863041
NCT03863041已完成不适用

Study of Phosphorylated Metabolism Profile as Predictive Biomarker of Cognitive Decline in Memory Complaint.

Poitiers University Hospital1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2019年4月8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
49
试验地点
1
主要终点
phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint.

研究概览

简要总结

Alzheimer disease is a frequent disease in the late ages that results in global alteration of cognitive functions. In which memory complaint can be isolated in the early stages.

Physiopathology of neuronal degenerescence in Alzheimer disease is complex, two main histological lesions are known, amyloid plaques and neurofibrillar tangles. Beyond the histological knowledge, alterations of neuronal metabolism are described such as oxydative phosphorylation and glycolytic pathway. These metabolism alterations are involved in neuronal death.

Multi-nucleus magnetic resonance spectroscopy is a non-invasive non-irradiant imagery technique already used in routine. This technic allows the phosphoenergetic pool assessment, that inform about cellular metabolism.

The aim of the study is to explore the phosphorylated metabolism patterns as predictive biomarkers of cognitive decline in patients with a memory complaint diagnosed.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Memory complaint, leading to a medical visit at the Centre Mémoire de Ressources et de Recherche (CMRR) of Poitiers, and for which an MRI is needed in routine exploration.
  • Age inferior at 90 years old
  • Mini Mental State Examination (MMSE) score between 20 and 30
  • Patient without guardianship measure, without restricted liberty.
  • Patient who benefits from social security

排除标准

  • Vascular, tumor, inflammatory pathology diagnosed by MRI
  • Other diagnosed neurodegenerative disease than Alzheimer disease
  • Other non neurodegenerative neurological disease
  • Vital risk at short term
  • Severe and uncontrolled psychiatric disease

结局指标

主要结局

phosphorylated metabolism profile assessment as predictor of cognitive decline in patients with memory complaint.

时间窗: ONE YEAR

correlation between brain phosphorylated metabolism (Pcr, ATP, PME, PDE, cho, NAA, Cr, PH) at the inclusion and MMSE on 2 years.

次要结局

  • Evolution of multinuclear magnetic resonance spectroscopy data at one year and cognitive decline at one year.(ONE YEAR)
  • Correlation between phosphoryled metabolite and variability of cerebro spinal fluid biomarkers(ONE YEAR)
  • Correlation between multinuclear magnetic resonance spectroscopy data and severity of cognitive dysfunction, at the inclusion and at one year.(ONE YEAR)
  • Correlation between phosphorylated metabolite and final diagnostic of Alzheimer disease or not.(ONE YEAR)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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