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临床试验/NCT05768425
NCT05768425进行中(未招募)不适用

DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY

Danish Dementia Research Centre1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
55
试验地点
1
主要终点
Diagnostic accuracy of Real-time quaking-induced conversion

研究概览

简要总结

This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.

详细描述

Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.

DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. A novel technique for the measurement of misfolded alpha-synuclein (aSyn) is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process.

Objective

Determining which biospecimen alone or in conjunction with other biospecimens can most accurately discriminate patients with DLB from Alzheimer's disease (AD) assessed by RT-QuIC for aSyn.

Design: Cross-sectional case-control study of the diagnostic accuracy of pathological alpha-synuclein assessed by RT-QuIC in different biospecimens (CSF, skin, olfactory mucosa, saliva, feces, and urine) from patients with DLB versus AD.

Patients will also be scored with tests for cognitive function, dysautonomia, and movement disorders.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Diagnostic accuracy of Real-time quaking-induced conversion

时间窗: 24 months

Area under the curb

次要结局

  • Sense of smell(24 months)
  • Cognitive function(24 months)
  • Dysautonomia(24 months)
  • Motor functions(24 months)

研究者

发起方
Danish Dementia Research Centre
申办方类型
Network
责任方
Sponsor

研究点 (1)

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