A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied

Trial Profile

A Principal, Open-Label, Single Center Study to Validate the Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Subjects Previously Biopsied

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2014

At a glance

  • Drugs Flutemetamol-F-18 (Primary)
  • Indications Alzheimer's disease
  • Focus Diagnostic use; Registrational
  • Sponsors GE Healthcare
  • Most Recent Events

    • 30 Jun 2014 The CHMP of the EMA provided a positive opinion on the MAA for Vizamyl indicated for PET imaging of the brain to estimate beta amyloid neuritic plaque density in patients evaluated for Alzheimer's disease.
    • 06 Nov 2013 New trial record
    • 25 Oct 2013 Data presented at Alzheimer's Association International Conference 2012 (AAIC-2012) and the American Academy of Neurology's (AAN) 64th Annual Meeting, according to GE Healthcare.
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