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

NCT ID: NCT03672279

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mild neurocognitive disorder

CogCheck

Intervention Type: DIAGNOSTIC_TEST

Novel self-administered cognitive assessment tool

Major neurocognitive disorder

CogCheck

Intervention Type: DIAGNOSTIC_TEST

Novel self-administered cognitive assessment tool

Interventions

CogCheck

Novel self-administered cognitive assessment tool

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Andreas Monsch

Prof. Dr. phil. Andreas U. Monsch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas U Monsch, PhD

Role: STUDY_CHAIR

Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER

Locations

Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Andreas U Monsch, PhD

Role: CONTACT

andreas.monsch@felixplatter.ch

+41 61 326 47 70

Alexandra S Wueest, MSc

Role: CONTACT

alexandra.wueest@felixplatter.ch

+41 61 326 47 51

Facility Contacts

Alexandra S Wüest, MSc

Role: primary

alexandra.wueest@felixplatter.ch

+41 61 326 47 51

Andreas U Monsch, PhD

Role: backup

andreas.monsch@felixplatter.ch

+41613264770

Other Identifiers

CogCheck-MC-Validation

Identifier Type: -

Identifier Source: org_study_id