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

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA) total score	Performance on the MoCA (0-30; higher score indicates better performance)	Administered once at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE) total score	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)	CERAD-NAB total score (0-120; higher score indicates better performance)	Administered once at baseline

Collaborators and Investigators

• Sponsor: Andreas Monsch
• Investigators: Principal Investigator: Andreas Monsch, PhD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2017
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): May 8, 2018

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: June 26, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Montreal Cognitive Assessment; Validation Study; Sensitivity; Specificity
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction; Neurocognitive Disorders
• Other Study ID Numbers: MoCA-Valid

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No