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Multi-modal Neuroimaging in Alzheimer's Disease (IMAP)

2013年3月5日 更新者:University Hospital, Caen

Study of the Predictive Markers and the Pathophysiological Mechanisms of Alzheimer's Disease: Transverse and Longitudinal Approach in Anatomical and Functional Multimodal Imaging

According to estimations, Alzheimer's disease affects approximately 860,000 people aged of more than 65 years in France. This disease is characterized by disorders of cognitive functions, including memory, associated with structural and functional modifications of the brain. These changes are evolving within the pathology progression and can be evaluated with neuropsychological tests (to assess capabilities such as language, orientation, etc.) and also with brain imaging (e.g. MRI). Alzheimer's disease is still poorly understood, nevertheless currently available treatments can slow its development if the disease is diagnosed early enough.

Thus, the objective is to identify markers for early diagnosis of Alzheimer's disease, to better describe the evolution of this disease.

The three main objectives of this project are

  • to identify, compare and combine predictive markers of Alzheimer's disease
  • to make a significant contribution to the understanding of the pathophysiological mechanisms of Alzheimer's disease
  • to study the ability of different neuroimaging techniques to follow the evolution of this pathology.

研究概览

研究类型

介入性

注册 (预期的)

295

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Caen、法国、14033
        • University Hospital Côte de Nacre
      • Lille、法国、59037
        • University Hospital Roger Salengro
      • Rennes、法国、35033
        • University Hospital Pontchaillou
      • Rouen、法国、76031
        • University Hospital Rouen
      • Tours、法国、37044
        • university hospital Tours

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Education level > 7 years
  • Native language: French
  • Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:

    • Healthy young controls: between 18 and 40 years old; normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
    • Healthy Middle-aged controls: between 40 and 60 years old; without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
    • Healthy Elderly controls: over 60 years old, living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery (± 1.5 SD).
    • MCI patients: over 60 years old, presenting the current criteria for amnestic MCI including: i) memory complaint, ii) deficits of the episodic memory (lower performance of at least 1.5 SD from the norm for age and cultural level for one or more scores of episodic memory and iii) normal performances compared to the age and the educational level of all other cognitive functions as memory, including tests to assess cognitive abilities.
    • Alzheimer's patients: presenting the standard criteria of NINCDS-ADRDA probable Alzheimer's disease, including abnormal global cognitive function and deficits in at least two cognitive domains identified by the diagnostic battery and a mild to moderate Alzheimer's disease (MMSE ≥ 15).

Exclusion Criteria:

  • The sudden onset of cognitive impairments (as opposed to their slow and gradual installation in Alzheimer's disease)
  • A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
  • A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
  • A medication that may interfere with memory or metabolic measures
  • A alcohol or drugs abuse
  • claustrophobia, metallic object in the body
  • A predominantly left-hand (score below 50% in Edinburgh Inventory).
  • Protected adults, and persons not affiliated with a social security system will not participate in this study.
  • The inclusion of a participant in another biomedical research protocol (during the study or within 12 months before inclusion)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Young controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Middle age controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Elderly controls
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Autosomal dominant forms of early-onset Alzheimer disease
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Subjectif Cognitive Impariment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Mild Cognitive Impairment patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Alzheimer Disease patients
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Non degenerative amnsesic syndrome
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.
实验性的:Frontotemporal lobe dementia
Assessment of memory, circulating tPA dosage, ApoE4, brain imaging examination MRI and PET examinations.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
全脑、海马体和其他结构 MRI 测量的体积变化率
大体时间:3年
3年
下降率通过以下指标衡量:认知测试、日常生活活动和 CDR 框总和
大体时间:3年
3年
每个指定生化生物标志物的变化率
大体时间:3年
3年
葡萄糖代谢变化率 (FDG-PET)
大体时间:3年
3年
通过 18F-AV45 测量淀粉样蛋白沉积的程度
大体时间:3年
3年
每个成像和生物标志物测量的组间差异
大体时间:3年
3年
APOE基因型
大体时间:3年
3年

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年1月1日

初级完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2012年3月13日

首先提交符合 QC 标准的

2012年3月13日

首次发布 (估计)

2012年3月14日

研究记录更新

最后更新发布 (估计)

2013年3月6日

上次提交的符合 QC 标准的更新

2013年3月5日

最后验证

2013年3月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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