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)

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.

Study Overview

• Status: Recruiting
• Conditions: Neurocognitive Disorders; Cognition Disorders; Mild Cognitive Impairment; Dementia Alzheimers
• Intervention / Treatment: Diagnostic test: CogCheck

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Andreas U Monsch, PhD; Phone Number: +41 61 326 47 70; Email: andreas.monsch@felixplatter.ch
• Study Contact Backup: Name: Alexandra S Wueest, MSc; Phone Number: +41 61 326 47 51; Email: alexandra.wueest@felixplatter.ch

Study Locations

• Switzerland
  • BS
    • Basel, BS, Switzerland, 4055
      • Recruiting
      • Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER
      • Contact: Alexandra S Wüest, MSc; Phone Number: +41 61 326 47 51; Email: alexandra.wueest@felixplatter.ch
      • Contact: Andreas U Monsch, PhD; Phone Number: +41613264770; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CogCheck	Results obtained in each subtest of CogCheck consisting of total scores and times (i.e., total seconds), where relevant for answering.	Baseline assessment

Secondary Outcome Measures

Outcome Measure	Time Frame
Mini-Mental State Examination (MMSE)	Baseline assessment
Montreal Cognitive Assessment (MoCA)	Baseline assessment
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)	Baseline assessment
Basel Verbal Learning Test (BVLT)	Baseline assessment
Geriatric Depression Scale (GDS)	Baseline assessment
Beck's Depression Inventory (BDI)	Baseline assessment
Feedback questionnaire to assess the user-friendliness of CogCheck	Baseline assessment

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Study Chair: Andreas U Monsch, PhD, Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders
• Other Study ID Numbers: CogCheck-MC-Validation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No