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

Mild Cognitive Impairment Clinical Trial

— CogCheck-MC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03672279
• Other study ID #: CogCheck-MC-Validation
• Status: Recruiting
• Start date: July 27, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Andreas U Monsch, PhD
• Phone: +41 61 326 47 70
• Email: andreas.monsch[@]felixplatter.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Dysfunction
• Dementia Alzheimers
• Mild Cognitive Impairment
• Neurocognitive Disorders

Intervention

Diagnostic Test:
• CogCheck
Novel self-administered cognitive assessment tool

Locations

Country	Name	City	State
Switzerland	Memory Clinic, University Department of Geriatric Medicine FELIX PLATTER	Basel	BS

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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