Trial document




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  DRKS00003721

Trial Description

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Title

Identification of biomarkers sensitive to disease progression in patients with Mild Cognitive Impairment. Two-part Research: Part A

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Trial Acronym

WP5P001 - Part A

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URL of the Trial

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Brief Summary in Lay Language

This part of the two-part study takes place in healthy participants. It is used to implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners). Therefore we apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients (Part B).

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Brief Summary in Scientific Language

This part of the two-part study takes place in healthy participants. It is used to implement a "common" MRI acquisition protocol in multiple centers across Europe (Pharma-COG partners). Therefore we apply the common MRI protocol on phantoms and human subjects to characterize, compare and minimize test-retest variability across the MR sites of WP5 for all the quantitative metrics that will be later assessed on patients (Part B).

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Organizational Data

  •   DRKS00003721
  •   2012/04/18
  •   2011/08/12
  •   no
  •   Approved
  •   11-4807-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   NCT01425957  (CinicalTrials.gov )
  •   DRKS00003705  (DRKS-ID Part B)
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Health Condition or Problem studied

  •   Healthy Subjects
  •   F00.0 -  Dementia in Alzheimer's disease with early onset
  •   F00.1 -  Dementia in Alzheimer's disease with late onset
  •   F00.2 -  Dementia in Alzheimer's disease, atypical or mixed type
  •   F00.9 -  Dementia in Alzheimer's disease, unspecified
  •   F06.7 -  Mild cognitive disorder
  •   Mild Cognitive Impairment
  •   Alzheimer's disease / Alzheimer dementia
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Interventions/Observational Groups

  •   Healthy participants (female/male) willing to participate at a MRI brain scan.
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Characteristics

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

Magnetic Resonance Imagery protocol [ Time Frame: Two sessions, one week apart] [ Designated as safety issue: No ]

The Magnetic Resonance Imagery protocol comprises a localiser or scout run, 4 structural-volumetric MRI sequences (i.e. 2 MP-RAGE, 1 FLAIR and 1 T2*), a resting state functional MRI acquisition (i.e. rsfMRI) and a diffusion tensor scan (i.e. DTI) that will be conducted at the magnetic field strength of 3T.

The main parameter of "efficacy" will be the reliability of the acquired MRI data (in terms of their correct acquisition and limited variability).

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   France
  •   Italy
  •   Spain
  •   Netherlands
  •   Greece
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/26
  •   5
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   50   Years
  •   80   Years
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Additional Inclusion Criteria

Participants will be (i) healthy volunteers (between 50 and 80 years old) and/or (ii) subjects (between 50 and 80 years old), who will perform a 3T-MRI for reasons such as migraine, headache, auditory or visual symptoms, paresthesias, and whose scan will be negative (see exclusion criteria below). Such subjects will be selected and asked to perform additional sequences according to the part A study protocol.

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Exclusion Criteria

-Ischaemic lesions already detected in a previous scan
-Head injury with loss of consciousness > 24 hours
-Current substance abuse
-Current therapy with steroids or current chemotherapy
-Loss of weight > 5 kg in the last 6 months
-Systemic disease with frequent involvement of the CNS (lupus, HIV, rheumatoid arthritis)
-CNS disease diagnosed by a specialist or in treatment (such as epilepsy, ictus)
-Cerebral metastasis or CNS primary tumour still benign (except for pituitary microadenoma)
-Suspected multiple sclerosis + MRI evidence of white matter lesions
-Suspected recent stroke + MRI evidence of infarct
-Aneurysm > 10 mm and arteriovenous malformations (except for venous angioma)
-Dysgenesia of central nervous system

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Addresses

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    • QUALISSIMA
    • Mr.  Romain  Combalat 
    • 10, rue Clapier
    • 13001  MARSEILLE
    • France
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    • Universitätsklinikum Duisburg-Essen, LVR Essen
    • Ms.  Dr.  Jennifer  Arnold 
    • Wickenburgstr. 23
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Duisburg-Essen, LVR Essen
    • Ms.  Dr.  Jennifer  Arnold 
    • Wickenburgstr. 23
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Innovative Medicines Initiative (IMI)
    • Avenue de la Toison d'Or 56-60
    • B-1060   Brussels
    • Belgium
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Status

  •   Recruiting complete, follow-up complete
  •   2012/09/19
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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.