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Validation of a Novel Self-Administered Cognitive Assessment Tool (CogCheck) in Patients With Mild and Major Neurocognitive Disorder Predominantly Due to Alzheimer's Disease (CogCheck-MC)

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ClinicalTrials.gov Identifier: NCT03672279
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Andreas Monsch, University Hospital, Basel, Switzerland

Study Description
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Brief Summary:

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 assessment of neurocognitive functioning ideally requires a tool that is short, easy to administer and interpret, and has high diagnostic accuracy. In this context, the use of computerized test batteries is receiving increasing attention. Compared to paper-pencil tests, computerized test batteries have many advantages. The possibility to measure reaction times may provide additional information. Moreover, test questions are always presented the exact same way, examiner-related bias is eliminated, and results are available immediately after examination. Due to the ability to adjust the level of difficulty to the performance of the individual, floor and ceiling effects may be minimized. Additionally, costs are reduced, and fewer materials and less trained personnel are required. Finally, big data approaches and the use of machine learning algorithms are becoming more popular in the field of clinical diagnostics, and computerized cognitive test batteries may facilitate future data collection to this aim.

In 2014, we developed a self-administered tablet computer program for the iPad (CogCheck) to assess preoperative cognitive functioning in surgery patients.

The cognitive tests used in the CogCheck application are identical or similar to the paper-and-pencil tests that are currently used in dementia diagnostics. Replacing some of the paper-and-pencil tests by a computerized test battery may facilitate the routine neuropsychological examinations. Thus, we aim to investigate the diagnostic accuracy and user-friendliness of CogCheck when applied in a cognitively impaired patient sample. In a first step, the diagnostic properties of CogCheck will be examined by differentiating between healthy controls and patients with mild or major neurocognitive disorder (NCD) predominantly due to Alzheimer's disease (AD). Data from healthy controls have been collected (EKNZ Req-2016-00393) in a previous normative study of CogCheck. Thus a further aim is to investigate the user-friendliness of CogCheck in patients with mild or major NCD predominantly due to AD.

The primary aim of our study is to investigate the diagnostic accuracy of CogCheck for patients with mild or major NCD predominantly due to AD in a German-speaking population.

Secondary aims are: (1) to examine the user-friendliness of CogCheck in patients with mild or major NCD predominantly due to AD, (2) to compare the results between cognitively healthy individuals (EKNZ Req-2016-00393) and patients with mild or major NCD predominantly due to AD on each of the CogCheck subtest, (3) to establish an algorithm with the CogCheck subtests that optimally distinguishes between cognitively healthy controls (EKNZ Req-2016-00393) and patients with mild or major NCD predominantly due to AD, (4) to compare the diagnostic properties of CogCheck with the ones of the currently used paper-pencil tests.


Condition or disease Intervention/treatment
Dementia Alzheimers Mild Cognitive Impairment Cognition Disorders Neurocognitive Disorders Diagnostic Test: CogCheck

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Novel Self-Administered Cognitive Assessment Tool (CogCheck) in Patients With Mild and Major Neurocognitive Disorder Predominantly Due to Alzheimer's Disease
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Mild neurocognitive disorder Diagnostic Test: CogCheck
Novel self-administered cognitive assessment tool
Major neurocognitive disorder Diagnostic Test: CogCheck
Novel self-administered cognitive assessment tool


Outcome Measures
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Primary Outcome Measures :
  1. CogCheck [ Time Frame: Baseline assessment ]
    Results obtained in each subtest of CogCheck consisting of total scores and times (i.e., total seconds), where relevant for answering.


Secondary Outcome Measures :
  1. Mini-Mental State Examination (MMSE) [ Time Frame: Baseline assessment ]
  2. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline assessment ]
  3. Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB) [ Time Frame: Baseline assessment ]
  4. Basel Verbal Learning Test (BVLT) [ Time Frame: Baseline assessment ]
  5. Geriatric Depression Scale (GDS) [ Time Frame: Baseline assessment ]
  6. Beck's Depression Inventory (BDI) [ Time Frame: Baseline assessment ]
  7. Feedback questionnaire to assess the user-friendliness of CogCheck [ Time Frame: Baseline assessment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is patients undergoing a neuropsychological assessment at the Memory Clinic of the University Department of Geriatric Medicine FELIX PLATTER in Basel, Switzerland.
Criteria

Inclusion Criteria:

  1. Age ≥65 years
  2. Education ≥7 years
  3. Fluency in the German language
  4. Completed neuropsychological assessment (max. 3 months before data collection of CogCheck)
  5. Informed consent signed
  6. Clinical course based on caregiver information and neuropsychological assessment profile strongly suggest mild or major NCD predominantly due to AD.

Exclusion Criteria:

  1. Severe sensory (e.g. auditory, visual) or motor impairment (e.g. essential tremor, paresis, dyskinesia) interfering with cognitive testing
  2. MMSE score ≤20/30 or MoCA ≤12/30.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672279


Contacts
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Contact: Andreas U Monsch, PhD +41 61 326 47 70 andreas.monsch@felixplatter.ch
Contact: Alexandra S Wueest, MSc +41 61 326 47 51 alexandra.wueest@felixplatter.ch

Locations
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Switzerland
Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER Recruiting
Basel, BS, Switzerland, 4055
Contact: Alexandra S Wüest, MSc    +41 61 326 47 51    alexandra.wueest@felixplatter.ch   
Contact: Andreas U Monsch, PhD    +41613264770    andreas.monsch@felixplatter.ch   
Principal Investigator: Andreas U Monsch, PhD         
Sub-Investigator: Alexandra S Wüest, MSc         
Sub-Investigator: Nicolai Goettel, MD         
Sub-Investigator: Luzius A Steiner, MD, PhD         
Sub-Investigator: Manfred Berres, PhD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Andreas U Monsch, PhD Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER
More Information
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Responsible Party: Andreas Monsch, Prof. Dr. phil. Andreas U. Monsch, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03672279    
Other Study ID Numbers: CogCheck-MC-Validation
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Disease
Cognitive Dysfunction
Neurocognitive Disorders
Cognition Disorders
Pathologic Processes
Dementia
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders