Trial document




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  DRKS00011373

Trial Description

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Title

Kölner Agnosie-Diagnostikum (KAD) - The development of a diagnostic tool for clinical diagnostics of visual agnosia

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Trial Acronym

KAD

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URL of the Trial

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Brief Summary in Lay Language

The aim of the project is the evaluation of the Kölner Agnosie-Diagnostikum (KAD) - a test for clinical diagnostics of visual agnosia developed in cooperation with the Uniklinik Köln – the teaching hospital of Cologne (Germany). Visual agnosia is a disorder of the recognition of visual stimuli which exists in different degrees and which is often category-specific. In this project, we are going to implement the KAD in a healthy sample (100 participants) and a clinical population (100 patients). The clinical Population consists of patients who are either suffering from parkinson's disease or who had an ischemic attack in a period of four weeks before the test date. After the data collection, the samples are going to be compared to calculate normative values.

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Brief Summary in Scientific Language

The aim of the project is the development of the Kölner Agnosie-Diagnostikum (KAD) – a psychometric test battery for clinical diagnostics and differential diagnostics of visual agnosia. Visual agnosia is a modality-specific disorder of the ability to recognize visual stimuli. The impaired recognition of forms, objects, faces, colors or letters cannot be explained by general cognitive or visual impairment. Visual agnosia can either be congenital or acquired through brain damage. To date, no standardized test for clinical diagnostics of visual agnosia is published. In order to enhance the understanding of the disorder and its behavioral manifestations and to integrate the diagnosis in therapy concepts, the development of an adequate test is necessary.
The project serves to ensure the scientific criteria of the KAD. The results of the clinical sample (N=100) will be compared to those of a healthy population (N=100). Additionally, we will implement well-established neuropsychological tests for the evaluation of cognitive functions (MMST; DemTect), depression (BDI-IV) and a sociodemographic questionnaire to compare the results of the participants in these tests with those from the KAD. To analyze the sensitivity and specificity of the KAD, a statistical ROC-curve analysis will be conducted. A final version of the KAD will be developed.

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Organizational Data

  •   DRKS00011373
  •   2016/12/14
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  •   yes
  •   Pending/not yet approved
  •   16-428, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   G20 -  Parkinson disease
  •   I63 -  Cerebral infarction
  •   I64 -  Stroke, not specified as haemorrhage or infarction
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Interventions/Observational Groups

  •   The Kölner Agnosie-Diagnostikum (KAD) will be implemented in a healthy sample to collect data for the calculation of normative values. The healthy sample consists of 100 participants (w=50, m=50) who participate voluntarily in the project. We target an even distribution of different age groups (18-90) and gender. Additionally, well-established diagnostic tools for the evaluation of cognitive functions (MMST; DemTect), depression and a sociodemographic questionnaire will be implemented to ensure that the results in the KAD cannot be explained by cognitive impairment or depression.
  •   The Kölner Agnosie-Diagnostikum (KAD) will be implemented in a clinical sample to collect data for the calculation of normative values. The clinical sample consists of 100 patients (w=50, m=50) who participate voluntarily and who either suffer from Parkinson’s disease or who had an ischemic attack in a period of four weeks before the test date. We target an even distribution of different age groups (18-90) and gender. Additionally, well-established diagnostic tools for the evaluation of cognitive functions (MMST; DemTect), depression and a sociodemographic questionnaire will be implemented to ensure that the results in the KAD cannot be explained by cognitive impairment or depression.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Diagnostic
  •   Parallel
  •   I
  •   N/A
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Primary Outcome

Development of the new psychometric Kölner-Agnosie Diagnostikum (KAD). Comparison of the two samples to define the normative values.
Correlation of the test results of the KAD with well-established tests for cognitive functions (MMST;DemTect), a sociodemographic questionnaire and an inventory for the diagnostics of depressive symptoms (BDI-IV).
ROC-curve Analysis to determinate the sensitivity and specificity of the test.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2017/02/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

age: 18-90; female and male; German language proficiency; written declaration of consent of the participant; normal or corrected vision and normal or corrected hearing; clinical sample: patients who suffer from Parkinson’s disease (stages II-III according to Hoahn & Yahr) or who had an ischemic attack in a period of four weeks before test date

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Exclusion Criteria

Impaired vision or hearing; clinically relevant depressive symptoms; current or retrospective alcohol- or drug abuse; existence of impaired cognitive functions that may influence the test results (DemTect ≤9)

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Addresses

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Sources of Monetary or Material Support

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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.