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临床试验/NCT03659643
NCT03659643Unknown不适用

Mild Cognitive Impairment, Use of qEEG as a Prognostic Marker

Jon Snaedal1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Diagnosis of dementia

研究概览

简要总结

Multi center study of six Memory Clinics in four Nordic countries in validating a prognostic diagnostic investigation of qEEG in Mild Cognitive Impairment (MCI). The study is in two parts, the first one is a follow up of a previous study conducted in 2011-2013 and the second half is new recruitment with two years follow up. End points are diagnosis of a dementing disorder, primarily dementia of Alzheimer´s type.

详细描述

The Nordic Network in Dementia Diagnostics (NIDD) conducted a study in 2011-2013 on qEEG using a method of Statistical Pattern Recognition (SPR) in six academic Memory Clinics in four Nordic countries. In the current study, those from the former study diagnosed either with Mild Cognitive Impairment (MCI; n= 120) or with Subjective Cognitive Impairment (SCI; n=60) are contacted again and evaluated for cognitive impairment. The EEG registered at entry in the former study is considered in relation to their current diagnosis (SCI,MCI or dementia) and thereby, the prognostic value of the method is evaluated.

In the second part of the study (n=120), new patients evaluated in the Memory Clinics and diagnosed with MCI (not SCI) are invited to participate for a two year follow up.

In the diagnostic work-up, simple screening tests and information from a close relative form the basis of the cognitive status (SCI;MCI, Dementia). In evaluating the cause of cognitive impairment, detailed neuropsychological testing is performed as well as MRI of the brain and CSF for Alzheimer´s markers. qEEG with SPR analysis is registered but the clinician is blinded to its outcome.

The end point in both parts of the study is a diagnosis of a dementing disorder.

研究设计

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

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Group 1: Individuals diagnosed with either SCI or MCI during 2011-2013 Group 2: Individuals diagnosed with MCI at entry of the study

排除标准

  • Age <50 years or >85 years
  • Medically or psychologically unstable
  • Living outside the capital region

结局指标

主要结局

Diagnosis of dementia

时间窗: Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration

The type of dementia is registered

次要结局

  • CERAD ten word test(Group 1: 4-6 years after initial registration, Group 2: 1-2 years after initial registration)

研究者

发起方
Jon Snaedal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jon Snaedal

Professor in Geriatric Medicine

Landspitali University Hospital

研究点 (1)

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