RecruitingNCT03672279

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


Sponsor

University Hospital, Basel, Switzerland

Enrollment

100 participants

Start Date

Jul 27, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new tablet-based tool called CogCheck that allows patients to complete memory and thinking tests on their own (without a specialist administering it), to see if it can accurately detect mild or major cognitive problems due to Alzheimer's disease. **You may be eligible if...** - You are 65 years old or older - You have at least 7 years of education - You are fluent in German - You have already completed a standard neuropsychological assessment within the past 3 months - Your clinical history and test results suggest mild or major cognitive impairment primarily due to Alzheimer's disease - You have signed an informed consent form **You may NOT be eligible if...** - You have severe sensory impairments (vision or hearing problems) that prevent use of the tool - You have other neurological conditions that are the primary cause of your cognitive problems - You are unable to understand or complete the assessments independently - You are not fluent in German Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTCogCheck

Novel self-administered cognitive assessment tool


Locations(1)

Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER

Basel, Canton of Basel-City, Switzerland

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NCT03672279


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