An open-label, non-randomized, multi-center study to optimize image assessment and evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) for detection/exclusi...

Mise à jour : Il y a 5 ans
Référence : EUCTR2007-002256-42

An open-label, non-randomized, multi-center study to optimize image assessment and evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) for detection/exclusion of cerebral beta-amyloid in patients with probable Alzheimer’s disease compared to healthy volunteers

Femme et Homme

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Extrait

To determine the sensitivity and specificity of the independent visual assessment of BAY 94-9172 PET images (from the 90 to 110 min imaging window) in detecting/excluding cerebral amyloid beta in patients with probable AD compared to HV. The clinical diagnosis - in Part A made by the investigator, in Part B established by an independent consensus panel - based on internationally accepted, validated criteria and established after comprehensive clinical and neuro-psychiatric examination, will serve as the standard of truth.


Critère d'inclusion

  • Probable Alzheimer Disease patients compared to Healthy Volunteers. The clinical diagnosis - in Part A made by the investigator, in Part B established by an independent consensus panel of experts in dementia - will serve as the standard of truth and will be based on internationally accepted, validated (diagnostic) criteria and established after comprehensive review of all available clinical, neuro-psychiatric and other relevant data

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