Trial document





This trial has been registered retrospectively.
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  DRKS00007581

Trial Description

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Title

Value and acceptance of magnetic imaging based risk stratification in early diagnosis of Alzheimer's disease

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Background: It is quite common that people suffering from cognitive impairement only go to see a doctor when the symptoms have already reached a severe stage. Reason is their fear of Alzheimer’s disease or their refusal against exhausting and personally exposing diagnostic procedures. Nevertheless an early diagnosis and therapy would both be helpful to improve life quality and to maintain it for a longer period of time.

Methods: In this prospective preventive survey 106 person with general risk factors had an image based risk stratification for Alzheimer’s diseaese. They were assesed by a standard magnetic resonance imaging (MRI) of the brain with subsequent hippocampal volumetry. According to the hippocampal atrophy the participants were divided into 2 groups, one with elevated and the other with reduced risk. All oft them underwent a thorough consultation regarding their fears, worries and well-being before and after the risk stratification.

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Brief Summary in Scientific Language

patient centered evaluation of a MRI based risk stratification on 106 participants via questionnaires to lead more patients to an early Alzheimer's disease diagnosis and it's derived benefits

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Organizational Data

  •   DRKS00007581
  •   2014/12/03
  •   [---]*
  •   no
  •   Approved
  •   11113, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

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

  •   Alzheimer's disease
  •   G30.9 -  Alzheimer disease, unspecified
  •   F00.9 -  Dementia in Alzheimer disease, unspecified
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Interventions/Observational Groups

  •   Patients with unclear cognitive impairments
    undergo a questionnaire about their risks and about their fears, worries and their well-being regarding Alzheimer's disease just before having a MRI of the brain with volumetric assessment. 3 weeks later, after a thorough counseling interview the questionnaire asseses the degree of fears, worries and well-being again.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

faster access to early Alzheimer's detection, measured via questionnaire

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Secondary Outcome

change worries and well-being after MRI based risk stratification

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2011/12/15
  •   106
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

adults interested in primary or secondary prevention through risk stratification regarding Alzheimer's disease. Adults perceiving cognitive impairment

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Exclusion Criteria

underage person

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Addresses

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    • MedPrevent Ottobrunn
    • Haidgraben 2
    • 85521  Ottobrunn
    • Germany
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    • Medprevent Ottobrunn
    • Mr.  Dr. med., M.Sc.  Oliver  Bartzsch 
    • Haidgraben 2
    • 85521  Ottobrunn
    • Germany
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    • MedPrevent Ottobrunn
    • Mr.  Dr. med, M. Sc.  Oliver  Bartzsch 
    • Haidgraben 2
    • 85521  Ottobrunn
    • Germany
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Sources of Monetary or Material Support

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    • MedPrevent Ottobrunn
    • Haidgraben 2
    • 85521  Ottobrunn
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/06/06
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Trial Publications, Results and other Documents

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