F03 F06.7
Conditions
Interventions
Group 1: Study part 1. We aim to compare the diagnostic accuracy achieved by an automated method against a gold standard diagnoses defined by clinical consensus based on all available data (e.g. medic
Sponsors
ZGGF
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Part 1 - first time referral - age > 40 - Subjects with mild to moderate dementia (CDR of 1 or below). Part 2 - first time referral - age > 40 - CDR of 0.5 - Age and education corrected Z-score below -1.5 in at least one of the CERAD items
Exclusion criteria
Exclusion criteria: - Dementia that is definitely not caused by neurodegeneration (e.g. severe trauma, brain tumor). Cases for which that cause does not explain the cognitive impairment with certainty (e.g. disease progression despite isolated trauma) will remain in the study to include a representative spectrum. - Inability to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The overall aim is the evaluation of the clinical usefulness of the computer tool with respect to supporting the diagnostic process. Usefulness is here defined as the ability to reach a diagnostic decision with high reliability in a substantial fraction of the patients or at least the ability to rule out some possible diagnoses in a reliable manner in a substantial fraction of the patients. Reliable means here a predictive value for the true status which is high enough to allow to stop or at least reduce the further diagnostic process compared to the current work up. A secondary aim is to compare the diagnostic accuracy of the computer tool with that of an experienced clinician with respect to three aspects: Main diagnose, secondary diagnose and differentiation between main and secondary diagnose. Part 2: The aim is to demonstrate that the prognostic accuracy of the computer tool is at least as good as the accuracy of the clinician, i.e. to declare it as non-inferior. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: In the secondary analyses we compare the accuracy of the main diagnose with that of the gold standard in cross tabulations allowing a detailed picture of the types of confusions. The accuracy itself is compared by the overall accuracy, i.e. the exact rate of agreement, as well as by the five sensitivities. Confidence intervals for the differences will be computed. Part 2: In the secondary analysis the comparison will be based on the R² values when regressing the change in the score versus the output of each procedure. In a sensitivity analysis, the relation between the change and the output will be modelled by fractioned polynomials. | — |
Countries
Germany
Contacts
Public ContactMichael Hüll
ZGGF
Outcome results
None listed