NCT03581643

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

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

March 6, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

July 10, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

May 30, 2018

Last Update Submit

June 26, 2018

Conditions

Alzheimer DiseaseMild Cognitive Impairment

Keywords

Montreal Cognitive AssessmentSensitivitySpecificityValidation Study

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA) total score

    Performance on the MoCA (0-30; higher score indicates better performance)

    Administered once at baseline

Secondary Outcomes (2)

  • Mini-Mental State Examination (MMSE) total score

    Administered once at baseline

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

    Administered once at baseline

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age ≥ 65 years.
  • Education ≥ 7 years.
  • Fluency in the German language.
  • Completed neuropsychological assessment.

You may not qualify if:

  • Severe sensory or motor impairment interfering with cognitive testing.
  • Documented refusal of the use of health-related personal data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memory Clinic, University Center for Medicine of Aging, Felix Platter Hospital Basel

Basel, Canton of Basel-City, 4002, Switzerland

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionHypersensitivity

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersImmune System Diseases

Study Officials

  • Andreas Monsch, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Psychology, Head Memory Clinic

Study Record Dates

First Submitted

May 30, 2018

First Posted

July 10, 2018

Study Start

March 6, 2017

Primary Completion

May 8, 2018

Study Completion

May 8, 2018

Last Updated

July 10, 2018

Record last verified: 2018-06

Locations

CH(1)