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

NCT03672279 | Recruiting

• 1 other identifier: CogCheck-MC-Validation
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia Alzheimers; Mild Cognitive Impairment; Cognition Disorders; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

Mild neurocognitive disorder

Diagnostic Test: CogCheck

Major neurocognitive disorder

Diagnostic Test: CogCheck

Interventions

CogCheck DIAGNOSTIC_TEST

Novel self-administered cognitive assessment tool

Major neurocognitive disorder; Mild neurocognitive disorder

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Severe sensory (e.g. auditory, visual) or motor impairment (e.g. essential tremor, paresis, dyskinesia) interfering with cognitive testing
• MMSE score ≤20/30 or MoCA ≤12/30.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER

Basel, Canton of Basel-City, 4055, Switzerland

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders

Study Officials

• Andreas U Monsch, PhD

  Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER

  STUDY CHAIR

Central Study Contacts

Andreas U Monsch, PhD

CONTACT

+41 61 326 47 70; andreas.monsch@felixplatter.ch

Alexandra S Wueest, MSc

CONTACT

+41 61 326 47 51; alexandra.wueest@felixplatter.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. phil. Andreas U. Monsch

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: July 27, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)