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临床试验/NCT03372317
NCT03372317招募中不适用

Tau Positron Emission Tomography (PET) in Imaging and Cognition

Yaakov Stern1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年6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
招募中
发起方
入组人数
105
试验地点
1
主要终点
Functional imaging (fMRI)

研究概览

简要总结

The investigators aim to use the new PET radioligand, 18F-MK-6240, to detect tau pathology in cognitive healthy and mild cognitive impairment (MCI) elders. The investigators will then examine the interactions between differential tau burden and performance on cognitive tasks, functional magnetic resonance imaging (fMRI) neural activation patterns, and other cognitive and behavioral measures. By investigating these relationships, the investigators hope to understand the cognitive and behavioral outcomes of tau deposition found in specific brain regions in cognitively normal/mildly cognitively impaired adults. Furthermore, the study aims to examine how the presence of tau may contribute to the risk of subsequent cognitive decline, neurodegeneration, and dementia.

详细描述

Many cognitively healthy older adults have, upon post mortem evaluations, been found to have varying amounts of neurofibrillary tangles (tau) and beta-amyloid plaque deposits, which are the hallmark brain pathologies known to be associated with Alzheimer's disease and various other dementias. While some with these pathologies may not clinically express cognitive decline or dementia in their lifetime, human post-mortem studies suggest that increasing neurofibrillary tangle density correlates with neurodegeneration and cognitive impairment.

Imaging tauopathy in-vivo provides an opportunity to examine neurocognitive correlates of differential levels of tauopathy in the brain, allowing to further qualify pre-clinical states of cognitive impairment. The investigators aim to investigate possible protective mechanisms, such as cognitive reserve, that may modulate the relationship between tauopathy and cognitive decline.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Aged 55-90
  • Previously received an amyloid PET scan
  • Residing near Columbia University Medical Center
  • Must be willing and able to participate

排除标准

  • Have a contraindication to PET (e.g, metallic implants, pacemaker, claustrophobia, or cannot lie flat for one hour)
  • Pregnancy
  • Lactating Women
  • Current, past, or anticipated exposure to radiation
  • Significant active physical illness

研究组 & 干预措施

Non-demented elders

Participants aged 55-90 that are cognitively normal or have mild cognitive impairment will receive 18F-MK-6240 to identify the presence of tau protein in the brain.

干预措施: 18F-MK-6240 (Drug)

结局指标

主要结局

Functional imaging (fMRI)

时间窗: Up to 5 years

Relation of Tau PET to imaging acquired during task performance

Total number of individuals with tau present

时间窗: Up to 5 years

Based on the scans, the total number of subjects with identifiable tau in their scans will be measured.

Cognition

时间窗: Up to 5 years

Relation of Tau PET to measures of cognition such as memory and reasoning

次要结局

未报告次要终点

研究者

发起方
Yaakov Stern
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yaakov Stern

Professor of Neuropsychology

Columbia University

研究点 (1)

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