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临床试验/NCT01642420
NCT01642420Unknown不适用

Quantitative Electroencephalography, Cerebrospinal Fluid Biomarkers, Linear CT Analyses and Timed Up and GO Dual Task as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression.

Zealand University Hospital1 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
115
试验地点
1
主要终点
Conversion from Mild Cognitive Impairment to Alzheimers disease

研究概览

简要总结

Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of examinations and tests, which combined can make AD diagnosis likely. But no single test or examination can unambiguous determine whether the patient has AD or not. Comparatively no examination or test can with accuracy predict whether a healthy person or a person with only mild cognitive (MCI)impairment in time will evolve AD.

Quantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely available diagnostic methods, which have the potential to diagnose AD at an early stage in a reliable accurate way. But they also have the potential to predict which patients diagnosed with MCI have particular risk of developing dementia.

The purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which patients with MCI will in time evolve AD.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For patients:
  • age 50 to 90
  • diagnosed with MCI or AD
  • cerebrospinal fluid examination and EEG performed at baseline
  • For control persons:
  • age 50 to 90
  • MMSE score equal or above 26
  • ACE score equal or above 85
  • Normal physical examination, including normal blood samples, CT of cerebrum and EEG examination

排除标准

  • Pregnant or breastfeeding
  • psychiatric disease, former depression is allowed if antidepressive treatment has been initiated of a leat 3 months duration
  • Neurologic or somatic disease, including former severe head trauma or neuroinfection
  • Antipsychotic treatment
  • Former severe abuse of alcohol, medication or drugs
  • ECT treatment or anaesthesia within the last 3 months
  • no closely related person to assist the patient
  • Additionally exclusion criteria for healthy control persons:
  • meet the diagnostic criteria for MCI or AD

结局指标

主要结局

Conversion from Mild Cognitive Impairment to Alzheimers disease

时间窗: Every year in totally of 3 years

The primary outcome measure is progression of clinical symptoms to an extent where the formal NINCDS-ADRDA criteria for dementia is meet. The progression is based upon clinical symptoms as well as explorative determinants in form of clinical tests, CSF analysis and qEEG analysis.

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

Malene Schjønning Nielsen

MD, PhD student

Zealand University Hospital

研究点 (1)

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