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临床试验/NCT01325259
NCT01325259已完成2 期

Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease

University Hospital, Tours8 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2009年4月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
54
试验地点
8
主要终点
Standard Uptake Value Ratios (SUVr)

研究概览

简要总结

Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection.

Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls.

Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype.

Method: Prospective multicentric study. 65 patients expected to enter the study.

Primary outcome measure: Standard Uptake Volume ratios.

研究设计

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

入排标准

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

入选标准

  • Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
  • 18 < MMS <= 28 for patients
  • 28 <= MMS for healthy volunteers
  • study period > 7 years
  • native language : french
  • signed informed consent
  • affiliated to a social security system

排除标准

  • alcoholism in medical history
  • arterial hypertension (180/100 and more)
  • chronical pulmonary disease with hypoxis
  • cranial traumatism with loss of consciousness > 15 minutes
  • severe depressive syndrome or anxiety
  • psychiatric disease in medical history (excepted simple episodes of depression)

结局指标

主要结局

Standard Uptake Value Ratios (SUVr)

时间窗: inclusion

Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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