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临床试验/NCT01609335
NCT01609335已完成1 期

Normative Values for Cognitive Testing and Alzheimer's Imaging Biomarkers in Young Adults (30-49yo)

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
41
试验地点
1
主要终点
Normal values for amyloid PET, FDG and Magnetic Resonance Imaging

研究概览

简要总结

Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, fludeoxyglucose (FDG) PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.

The investigators objective in this proposal is to obtain imaging biomarker data in a group of individuals who are appropriate for establishing normative values for AD biomarkers. The investigators believe the most valid approach to establishing biomarker cut points is to base them on the upper bound of the range observed in young to early-middle-age subjects in whom the presence of occult AD pathology is extremely unlikely. Based on a large volume of community-based autopsy data, that upper age limit would be about 50 years old. The lower age bound for a group of subjects used to establish normative AD biomarker values would have to be based on considerations of brain maturation, which may continue into the middle- to late-20s. Thus, taking the above into consideration, the ideal age range for establishing normative AD imaging biomarker data (amyloid PET, FDG PET, and structural MRI) may be ages 30-49 years old.

研究设计

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

入排标准

年龄范围
30 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Cognitively normal males or females aged 30 to 49 years old.

排除标准

  • Subjects unable to lie down without moving for up to 45 minutes.
  • Women who are pregnant or cannot stop breast feeding for 24 hours.
  • Claustrophobic patients unable to tolerate the scans (no sedation can be offered).
  • Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.

研究组 & 干预措施

Cognitively Normal Subjects

Other

Study participation will consist of tests of memory and thinking, a MRI, and two PET scans. F-18 FDG and C-11 Pittsburgh compound B (PiB) are two drugs used in PET scans.

干预措施: F-18 FDG (Drug)

Cognitively Normal Subjects

Other

Study participation will consist of tests of memory and thinking, a MRI, and two PET scans. F-18 FDG and C-11 Pittsburgh compound B (PiB) are two drugs used in PET scans.

干预措施: C-11 PiB (Drug)

结局指标

主要结局

Normal values for amyloid PET, FDG and Magnetic Resonance Imaging

时间窗: 2 days

Biomarkers of Alzheimer's disease (AD) occupy an essential place in recently formulated diagnostic criteria for AD where their role is to identify the pathophysiological processes underlying cognitive impairment or to predict time to dementia. Three of these biomarkers are brain imaging tests (amyloid PET, FDG PET, and structural MRI). In order to effectively use AD biomarkers for diagnostic and prognostic purposes, continuous values much be divided into normal and abnormal ranges. This requires that a cut point(s) be established in the continuous distribution of values for each biomarker.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Val Lowe

Consultant - Diagnostic Radiology

Mayo Clinic

研究点 (1)

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