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Validation of the Montreal Cognitive Assessment in Patients With Mild and Major Neurocognitive Disorder (MoCA-Valid)

2018年6月26日 更新者:Andreas Monsch

The primary aim of our study is to investigate the specificity, the sensitivity, and the overall diagnostic accuracy of the MoCA for mild and major NCD in a German-speaking population.

Secondary aims are: (1) to study the MoCA performance in different patient groups and (2) to compare the diagnostic properties of the MoCA with the ones of the MMSE (i.e., the current reference standard for screening of MCI).

研究概览

地位

完全的

详细说明

Due to the demographical development, age-related diseases will drastically increase over the next decades. To face this healthcare challenge, early and accurate identification of cognitive impairment is crucial. The early detection of cognitive decline requires a tool that is short, easy to administer and interpret, and has high diagnostic accuracy. Currently, a widely used instrument is the Mini-Mental State Examination (MMSE). However, the MMSE sensitivity is poor when identifying individuals with MCI, and it lacks meaningful assessment of executive functions. The Montreal Cognitive Assessment (MoCA) has been developed to address these weaknesses. It has demonstrated better diagnostic accuracy in patients with MCI, has less ceiling effect, and a higher test-retest-reliability. In addition, the MoCA better captures the cognitive domains proposed in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

In 2018, the investigators generated demographically adjusted normative values for the German version of the MoCA in cognitively healthy individuals. However, these normative data alone are not suitable to determine the exact diagnostic accuracy. Therefore, the investigators aim to analyze data from patients with cognitive disorders to validate the German version of the MoCA.

Validation studies for the MoCA have been performed in various languages and different etiologies, mainly in patients with MCI and AD. However, when applying the MoCA in a clinical routine setting, the patient population is more heterogeneous and different etiologies may lead to deficits in characteristic cognitive domains. Therefore, patients with diseases other than AD may perform differently on items of the MoCA. This might translate into differences regarding the optimal cut-off score to detect possible cognitive impairment. Thus, when solely relying on a cut-off score that has been validated in a population of AD patients, patients with other diseases leading to cognitive impairment may be missed.

The investigators therefore aim to establish the diagnostic accuracy of the MoCA when applied in a clinically diverse patient sample, namely, a sample that is seen in a typical Memory Clinic. In a first step, the diagnostic properties of the MoCA will be investigated by differentiating between healthy controls and all patients with mild and major neurocognitive disorders (NCD). In a second step, healthy controls will be compared separately to patients with mild NCD and to patients with major NCD. The investigators further aim to investigate the aptness of the MoCA for differential diagnostic. The MoCA performance of different diagnostic patient groups will be compared. Investigating the presence or absence of deficits per subitem in each patient group may reveal if different etiologies lead to characteristic MoCA profiles.

研究类型

观察性的

注册 (实际的)

430

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • BS
      • Basel、BS、瑞士、4002
        • Memory Clinic, University Center for Medicine of Aging, Felix Platter Hospital Basel

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 及以上 (年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

Patients undergoing the routinely held neuropsychological assessments in the Memory Clinic, University Center for Medicine of Aging, Felix Platter Hospital in Basel, Switzerland.

描述

Inclusion Criteria:

  • Age ≥ 65 years.
  • Education ≥ 7 years.
  • Fluency in the German language.
  • Completed neuropsychological assessment.

Exclusion Criteria:

  • Severe sensory or motor impairment interfering with cognitive testing.
  • Documented refusal of the use of health-related personal data.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Montreal Cognitive Assessment (MoCA) total score
大体时间:Administered once at baseline
Performance on the MoCA (0-30; higher score indicates better performance)
Administered once at baseline

次要结果测量

结果测量
措施说明
大体时间
Mini-Mental State Examination (MMSE) total score
大体时间:Administered once at baseline
Performance on the MMSE (0-30; higher score indicates better performance)
Administered once at baseline
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
大体时间:Administered once at baseline
CERAD-NAB total score (0-120; higher score indicates better performance)
Administered once at baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Andreas Monsch, PhD、University Hospital, Basel, Switzerland

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年3月6日

初级完成 (实际的)

2018年5月8日

研究完成 (实际的)

2018年5月8日

研究注册日期

首次提交

2018年5月30日

首先提交符合 QC 标准的

2018年6月26日

首次发布 (实际的)

2018年7月10日

研究记录更新

最后更新发布 (实际的)

2018年7月10日

上次提交的符合 QC 标准的更新

2018年6月26日

最后验证

2018年6月1日

更多信息

与本研究相关的术语

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