Cognitive ImpairmentMoCA-NormNCT03246269
Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)
An observational study of Cognitive Impairment and Cognitive Decline, run by Andreas Monsch.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Cognitive Decline, Cognition Disorders
- What is being tested?
- MoCA
- How many people
- 334 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy volunteers
Who may be able to join
- Age ≥65 years
- Education ≥7 years
- Fluency in the German language
- Written informed consent
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Cognitive Impairment, Cognitive Decline, Cognition Disorders, Cognitive Symptom, Cognitive Change, Cognitive Deterioration
- Being tested
- MoCA
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders, Neurobehavioral Manifestations, Dementia, Alzheimer Disease, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoCADiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| MoCA cohort | The German MoCA is administered once to all study participants. Receives: Diagnostic Test: MoCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) - German version
Total score of the MoCA
Measured: Baseline
Secondary outcomes (3)
Mini-Mental State Examination (MMSE)
Total score of the MMSE
Measured: Baseline
Geriatric Depression Scale (GDS)
Total score of the GDS
Measured: Baseline
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
Total score of the CERAD-NAB
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study startDec 2016
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andreas Monsch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andreas Monsch, University Hospital, Basel, Switzerland
- Investigators
- Alessandra Thomann, MSc, Principal investigator, Felix Platter Hospital BaselNicolai Goettel, MD, Principal investigator, University Hospital, Basel, SwitzerlandRaphael Monsch, MD, Principal investigator, University Hospital, Basel, SwitzerlandManfred Berres, PhD, Principal investigator, University of Applied Sciences KoblenzAndreas Monsch, PhD, Study chair, Felix Platter Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246269
- Sponsor's protocol ID
- MoCA-Norm
- Acronym
- MoCA-Norm
- Status last verified
- May 2018
- First submitted
- 8 Aug 2017
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Values for the German Version of the Montreal Cognitive Assessment (MoCA)
- ClinicalTrials.gov ID
- NCT03246269
- Acronym / sponsor ID
- MoCA-Norm / MoCA-Norm
- Conditions
- Cognitive Impairment, Cognitive Decline, Cognition Disorders, Cognitive Symptom, Cognitive Change, Cognitive Deterioration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Andreas MonschUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 11 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MoCA cohort | – | Diagnostic Test: MoCAThe German MoCA is administered once to all study participants. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (4 listed)
- Age ≥65 years
- Education ≥7 years
- Fluency in the German language
- Written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoCA | Diagnostic test | MoCA cohort |
Primary outcome
Montreal Cognitive Assessment (MoCA) - German version
Time frame: Baseline
Total score of the MoCA
3 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: Baseline
Geriatric Depression Scale (GDS)
Time frame: Baseline
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Thomann, MSc principal investigator
Felix Platter Hospital Basel
Nicolai Goettel, MD principal investigator
University Hospital, Basel, Switzerland
Raphael Monsch, MD principal investigator
University Hospital, Basel, Switzerland
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment and Cognitive Decline, run by Andreas Monsch.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) - German version (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2018.