- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246269
Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA) (MoCA-Norm)
May 30, 2018 updated by: Andreas Monsch
This observational cohort study in healthy volunteers establishes normative data for the German version of the Montreal Cognitive Assessment (MoCA) and investigates the possible impacts of demographics on the MoCA total score.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Montreal Cognitive Assessment (MoCA) is a short tool to evaluate a multitude of cognitive domains (visuospatial / executive functioning, object naming, memory, attention, language, abstraction, orientation).
The original English MoCA consistently showed very high sensitivity and specificity in distinguishing patients with mild cognitive impairment from healthy controls.
Therefore it is an excellent tool for early recognition of cognitive disorders.
Based on a Canadian sample, the MoCA proposes a cut-off-value of 26/30 points.
However, there is increasing evidence of intercultural differences in terms of the best cut-off-score.
In addition the original version only slightly corrects for possible influences of education - an adjustment for age- or gender-related effects is missing.
Therefore, the aim of our study was to investigate the possible impacts of demographics on the MoCA total score and to provide normative values for a German-speaking population.
Study Type
Observational
Enrollment (Actual)
334
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
61 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy volunteers
Description
Inclusion Criteria:
- Age ≥65 years
- Education ≥7 years
- Fluency in the German language
- Written informed consent
Exclusion Criteria:
- History of cognitive impairment
- Depression
- Severe sensory or motor impairment interfering with cognitive testing
- Serious somatic disease
- Disease or event affecting the central nervous system
- Cerebrovascular disease
- Regular medication with psychoactive drugs except for benzodiazepines
- Participation in a cognitive study within the last 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MoCA cohort
The German MoCA is administered once to all study participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA) - German version
Time Frame: Baseline
|
Total score of the MoCA
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Mental State Examination (MMSE)
Time Frame: Baseline
|
Total score of the MMSE
|
Baseline
|
|
Geriatric Depression Scale (GDS)
Time Frame: Baseline
|
Total score of the GDS
|
Baseline
|
|
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
Time Frame: Baseline
|
Total score of the CERAD-NAB
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alessandra Thomann, MSc, Felix Platter Hospital Basel
- Principal Investigator: Nicolai Goettel, MD, University Hospital, Basel, Switzerland
- Principal Investigator: Raphael Monsch, MD, University Hospital, Basel, Switzerland
- Principal Investigator: Manfred Berres, PhD, University of Applied Sciences Koblenz
- Study Chair: Andreas Monsch, PhD, Felix Platter Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
April 1, 2017
Study Registration Dates
First Submitted
August 8, 2017
First Submitted That Met QC Criteria
August 8, 2017
First Posted (Actual)
August 11, 2017
Study Record Updates
Last Update Posted (Actual)
May 31, 2018
Last Update Submitted That Met QC Criteria
May 30, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Disease
- Dementia
- Alzheimer Disease
- Cognitive Dysfunction
- Neurobehavioral Manifestations
- Cognition Disorders
Other Study ID Numbers
- MoCA-Norm
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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