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Validation of a Novel Self-Administered Cognitive Assessment Tool (CogCheck) in Patients With Mild and Major Neurocognitive Disorder (CogCheck-MC)

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ClinicalTrials.gov Identifier: NCT03672279
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Andreas Monsch, University Hospital, Basel, Switzerland

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 investigated by differentiating between healthy controls and patients with mild and major neurocognitive disorders (NCD). We further aim to investigate the aptness of CogCheck for differential diagnostic by comparing the CogCheck performance of different diagnostic patient groups.

The primary aim of our study is to investigate the diagnostic accuracy of CogCheck for mild and major NCD in a German-speaking population.

Secondary aims are: (1) to examine the user-friendliness of CogCheck, (2) to study the CogCheck performance in different patient groups, and (3) to compare the diagnostic properties of CogCheck with the ones of the currently used paper-and-pencil tests.


Condition or disease Intervention/treatment
Dementia Alzheimers Dementia Mild Cognitive Impairment Dementia, Vascular Dementia With Lewy Bodies Cognition Disorders Neurocognitive Disorders Diagnostic Test: CogCheck

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a Novel Self-Administered Cognitive Assessment Tool (CogCheck) in Patients With Mild and Major Neurocognitive Disorder
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


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




Primary Outcome Measures :
  1. CogCheck [ Time Frame: Baseline assessment ]
    Results obtained in each subtest of CogCheck consisting of total scores and times (i.e., total seconds).


Secondary Outcome Measures :
  1. Mini-Mental State Examination (MMSE) [ Time Frame: Baseline assessment ]
  2. Montreal Cognitive Assessment (MoCA) [ Time Frame: Baseline assessment ]
  3. Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB) [ Time Frame: Baseline assessment ]
  4. Basel Verbal Learning Test (BVLT) [ Time Frame: Baseline assessment ]
  5. Geriatric Depression Scale (GDS) [ Time Frame: Baseline assessment ]
  6. Beck's Depression Inventory (BDI) [ Time Frame: Baseline assessment ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population is patients undergoing a neuropsychological assessment at the Memory Clinic, or in-hospital patients of the Department of Acute Geriatrics, University Center for Medicine of Aging, Felix Platter Hospital, in Basel, Switzerland.
Criteria

Inclusion Criteria:

  1. Age ≥65 years,
  2. Education ≥7 years,
  3. Fluency in the German language,
  4. Completed neuropsychological assessment
  5. Informed consent (if MMSE score <20/30, an additional consent from the patient's informant is required).

Exclusion Criteria:

(1) Severe sensory or motor impairment interfering with cognitive testing.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672279


Contacts
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Contact: Andreas U Monsch, PhD +41 61 326 47 70 andreas.monsch@fps.ch
Contact: Alessandra E Thomann, MSc +41 61 326 47 60 alessandra.thomann@fps.ch

Locations
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Switzerland
Memory Clinic, University Center for Medicine of Aging, Felix Platter Hospital Basel Not yet recruiting
Basel, BS, Switzerland, 4002
Contact: Alessandra E Thomann, MSc    +41613285130    alessandra.thomann@fps.ch   
Contact: Andreas U Monsch, PhD    +41613264770    andreas.monsch@fps.ch   
Principal Investigator: Andreas U Monsch, PhD         
Sub-Investigator: Alessandra E Thomann, MSc         
Sub-Investigator: Nicolai Goettel, MD         
Sub-Investigator: Luzius A Steiner, MD, PhD         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Andreas U Monsch, PhD Memory Clinic, Felix Platter Hospital Basel

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Responsible Party: Andreas Monsch, Prof. Dr. phil. Andreas U. Monsch, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03672279     History of Changes
Other Study ID Numbers: CogCheck-MC-Valid
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Dementia, Vascular
Disease
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Alzheimer Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Neurodegenerative Diseases
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Tauopathies