Trial document




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  DRKS00003199

Trial Description

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Title

Applicability of automated MR-based diagnosing in a memory clinic

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Here we plan to evaluate the range of potential applications of automated MR-based diagnostic methods in a memory clinic. In the long run, we hope that this study will contribute to a wide application of such methods in the clinical routine.

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Brief Summary in Scientific Language

Recent developments in machine-learning analysis methods and their application to neuroimaging (Davatzikos et al., 2009; Duchesnay et al., 2007; Fan et al., 2006; Fan et al., 2007; Kloppel et al., 2008a; Kloppel et al., 2008b; Lerch et al., 2008; Mourao-Miranda et al., 2005; Teipel et al., 2007a; Teipel et al., 2007b; Vemuri et al., 2008a; Vemuri et al., 2008b) are very encouraging in relation to the levels of diagnostic accuracy achievable in individual patients. These multivariate methods promise fully automated, standard PC-based clinical decisions, unaffected by individual neuroradiological expertise which strongly affects diagnostic accuracy. They are sufficiently sensitive to successfully separate those with mild cognitive impairment (MCI, (Petersen et al., 2001)) from the cognitively normal (Davatzikos et al., 2008) or identify those cognitively normal subjects who will convert to MCI (Davatzikos et al., 2009).
Research aims:
Can the automated methods
1.)aid in the identification of those with MCI who will continue to develop dementia?
2.) improve diagnostic accuracy in those with clinically diagnosed dementia?

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Organizational Data

  •   DRKS00003199
  •   2011/07/26
  •   [---]*
  •   yes
  •   Approved
  •   237/11, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F03 -  Unspecified dementia
  •   F06.7 -  Mild cognitive disorder
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Interventions/Observational Groups

  •   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. medical history, neuropsychology, routine MR without computerized analysis and PET imag-ing) obtained in the clinical workup. The clinical diagnosis is found independently of the com-puter algorithm and without altering the diagnostic procedure in the memory clinic.

    Study part 2. In this part of the proposal, we compare the ability of the computerised method to identify patients with MCI who convert to any type of dementia as accurately as the clinician. Follow-up examinations after 12 months will serve as gold standard.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

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.

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Secondary Outcome

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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Planned
  •   2011/08/01
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   no maximum age
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Additional 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

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • ZGGF
    • Mr.  Prof.   Michael  Hüll 
    • Lehener Str. 88
    • 79108   Freiburg
    • Germany
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    • ZGGF
    • Mr.  Prof.   Michael  Hüll 
    • Lehener Str. 88
    • 79108   Freiburg
    • Germany
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    • ZGGF
    • Mr.  Prof.   Michael  Hüll 
    • Lehener Str. 88
    • 79108   Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • ZGGF
    • Mr.  Prof.   Michael  Hüll 
    • Lehener Str. 88
    • 79108   Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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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.