NCT03246269

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

August 8, 2017

Last Update Submit

May 30, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA) - German version

    Total score of the MoCA

    Baseline

Secondary Outcomes (3)

  • Mini-Mental State Examination (MMSE)

    Baseline

  • Geriatric Depression Scale (GDS)

    Baseline

  • Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)

    Baseline

Study Arms (1)

MoCA cohort

The German MoCA is administered once to all study participants.

Diagnostic Test: MoCA

Interventions

MoCADIAGNOSTIC_TEST
MoCA cohort

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Age ≥65 years
  • Education ≥7 years
  • Fluency in the German language
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionCognition DisordersNeurobehavioral ManifestationsDementiaAlzheimer DiseaseLymphoma, Follicular

Condition Hierarchy (Ancestors)

Neurocognitive DisordersMental DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Andreas Monsch, PhD

    Felix Platter Hospital Basel

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 11, 2017

Study Start

December 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 31, 2018

Record last verified: 2018-05