Trial document




drksid header

  DRKS00004628

Trial Description

start of 1:1-Block title

Title

Transfer of plasma samples for assay development in the patent application "New approaches to Alzheimer's diagnosis"

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In the above study we collect blood samples from healthy and diseased people aged 50 vears and older. This will only be done when there is no contraindication for taking a blood sample and a informed consent was signed. The blood samples will be anonymised after collection. The samples will be used for testing a new method of investigation. This new method will be used in the future in the context of early Alzheimer's diagnosis.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

This study uses anonymised blood samples from healthy and diseased subjects to check a new method for diagnosis of Alzheimer Dementia. The new research method is to be used in the future in the diagnosis of Alzheimer Dementia.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004628
  •   2013/01/10
  •   [---]*
  •   yes
  •   Approved
  •   12-5300-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer's disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Healthy and diseased subjects receive a blood draw. The samples will be anonymised and used for an assaydevelopment.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Development of immunological tests for human blood plasma for determining the concentration of Aβ (1-40) and Aβ (1-42) and for comparison.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

/

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2013/01/15
  •   80
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

a) The study participant can understand the situation, the clinical trial and the consequences of taking part at the clinical trial and the participant is in position to give the consent;
b) the study participants signed and personally dated the consent before any test-specific action is taken;
c) age of the study participant is 50 years or older.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Health concerns against sampling blood as study-specific measure.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • LVR-Klinikum Essen, Kliniken und Institut der Universität Duisburg-Essen
    • Mr.  Prof. Dr.  Jens  Wiltfang 
    • Altendorfer Str. 97-101
    • 45127  Essen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • LVR-Klinikum Essen, Kliniken und Insitut der Universität Duisburg-Essen
    • Mr.  Prof. Dr.  Jens  Wiltfang 
    • Altendorfer Str. 97-101
    • 45127  Essen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • LVR-Klinikum Essen, Kliniken und Institut der Universität Duisburg-Essen
    • Ms.  Sinja Henrike  Meyer 
    • Wickenburgstr. 23
    • 45147  Essen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • LVR-Klinikum Essen, Kliniken und Institut der Universität Duisburg-Essen
    • Mr.  Prof. Dr.  Jens  Wiltfang 
    • Altendorfer Str. 97-101
    • 45127  Essen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/09/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.