跳至主要内容
临床试验/NCT01815112
NCT01815112终止不适用

Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
60
试验地点
2
主要终点
Dynamic FDG (fluoro-deoxyglucose) PET

研究概览

简要总结

The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia.

In AD the investigators observe:

  • A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter.
  • A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.

Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities:

  • Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain
  • Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus.

The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: over 65
  • •Participants (or representatives) gave their written informed consent
  • •Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria
  • •For Alzheimer arm: probable Alzheimer based disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association ) criteria
  • •For vascular dementia: diagnosis based on NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences) criteria
  • •For MCI: diagnosis based on Petersen index

排除标准

  • •Claustrophobia
  • •Cardiovascular disease
  • •Glycemia over 1.3 g/L
  • •Lumbar puncture within one week before MRI examination
  • •Non MR-compatible implant
  • •Suspected brain metastases
  • •No informed consent signature

研究组 & 干预措施

Alzheimer

Experimental

Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.

干预措施: Magnetic resonance imaging (Other)

Alzheimer

Experimental

Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.

干预措施: Positron emission tomography (Other)

Vascular dementia

Experimental

Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.

干预措施: Magnetic resonance imaging (Other)

Vascular dementia

Experimental

Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.

干预措施: Positron emission tomography (Other)

Mild cognitive impairment (MCI)

Experimental

Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.

干预措施: Magnetic resonance imaging (Other)

Mild cognitive impairment (MCI)

Experimental

Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.

干预措施: Positron emission tomography (Other)

Healthy subjects (MRI)

Experimental

Healthy subjects agreeing to undergo magnetic resonance imaging examination.

干预措施: Magnetic resonance imaging (Other)

Healthy subjects (PET)

Experimental

Cognitively healthy subjects. These subjects are people addressed in the nuclear medicine department for cancer-related positron emission tomography examination. If they agree, an extended neuropsychological test will assess that they do not suffer any cognitive disorder.

干预措施: Positron emission tomography (Other)

结局指标

主要结局

Dynamic FDG (fluoro-deoxyglucose) PET

时间窗: Day 2

Extraction of tissue time-activity curves ; notably in choroid plexus.

次要结局

  • Aqueductal CSF flow(Day 1)
  • Follow-up MRI(Day 365)
  • Follow-up PET(Day 366)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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