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

A

Andreas Monsch

Status

Completed

Conditions

Alzheimer Disease
Mild Cognitive Impairment

Study type

Observational

Funder types

Other

Identifiers

NCT03581643
MoCA-Valid

Details and patient eligibility

About

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).

Full description

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.

Enrollment

430 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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