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临床试验/NCT03024944
NCT03024944撤回2 期

TAU PET Imaging in Northern Manhattan Study of Metabolism and Mind

Columbia University1 个研究点 分布在 1 个国家开始时间: 2017年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
撤回
试验地点
1
主要终点
Amount of Tau Accumulation by Measuring Standardized Uptake Value Ratio (SUVR)

研究概览

简要总结

The purpose of this project is to study brain imaging of a substance called tau, which is found in brains of persons with Alzheimer's disease, using the Tau binder, 18F-THK-5351, for live imaging of tau in the brain. The main goal of this proposal is to study whether diabetes status (type 2 diabetes [referred to as diabetes] and pre-diabetes, compared with normal glucose tolerance [NGT]), is associated with increased tau accumulation in the brain, one of the culprits of Alzheimer's disease, in a community-based group of middle aged Caribbean-Hispanics with a mean age of 63 years. The investigators propose to conduct tau positron emission tomography (PET) imaging in 30 middle aged Hispanics.

详细描述

The burden of late onset Alzheimer's dementia (LOAD) and its antecedents is increasing without known prevention or cure, and diabetes seems to be one of the strongest risk factors. The predominating causal model in Alzheimer's disease (AD) research is based on the amyloid hypothesis, which posits that amyloid (A) deposition in the brain causes synaptic dysfunction resulting in early memory deficits and progression to mild cognitive impairment (MCI) and dementia. Tau has also gained increasing interest as an AD pathology feature, biomarker, and treatment target.

There are no known curative or preventive measures for LOAD. One of the strongest potential LOAD risk factors is type 2 diabetes, an abnormal elevation of blood glucose associated with microvascular and macrovascular complications including cerebrovascular disease. Many studies have reported an association of diabetes with dementia, including LOAD and vascular dementia (VD). Most studies have found that diabetes is associated with an increased risk of both LOAD and VD, with a stronger association for VD compared with LOAD. Thus, this study focuses on the relation of diabetes, pre-diabetes, and elevated glucose, with AD.

研究设计

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

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All persons who have undergone magnetic resonance imaging (MRI) and amyloid PET already, or those who prospectively are deemed eligible for the parent study covered under protocol AAAQ2950, will be approached for participation.

排除标准

  • Person who are not participating in the MRI and amyloid PET under protocol AAAQ2950

研究组 & 干预措施

Brain Imaging with 18F-THK-5351

Experimental

This group consists of 30 adult subjects: 10 with Type 2 diabetes, 10 with pre-diabetes, and 10 with normal glucose tolerance. Each subject will receive a baseline scan and a follow-up PET scan with 18F-THK-5351.

干预措施: 18F-THK-5351 (Drug)

结局指标

主要结局

Amount of Tau Accumulation by Measuring Standardized Uptake Value Ratio (SUVR)

时间窗: 2 Years

The primary aim is to measure 18THK-5351 binding (SUVR) in medial temporal and inferior temporal cortex, cross-sectionally and longitudinally.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José A. Luchsinger

Associate Professor of Medicine and Epidemiology

Columbia University

研究点 (1)

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