GE-067-007 Brain Amyloid Study

• Research type

  Research Study

• Full title

  A Principal Open-Label Study to Compare the Brain Uptake of [18F]flutemetamol with Brain Amyloid Levels Determined Post-Mortem

• IRAS ID

  35214

• Contact name

  Zuzana Walker

• Sponsor organisation

  GE Healthcare Ltd

• Eudract number

  2009-013030-25

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Amyloid is an abnormal deposit of protein in the body. It is associated with over 30 human diseases including Alzheimer's disease. In Alzheimer's disease, amyloid deposition in the brain affects memory and thinking. However, amyloid can sometimes be found in the brain without causing problems. Currently, the only means to detect amyloid is histopathological analysis of brain tissue collected during a brain biopsy or post mortem examination, using immunohistochemistry or histochemical dyes. Brain biopsy is rarely done because it is so invasive. <fluemetamol is a new radioactive drug intended for use with PET imaging for detecting amyloid in the living brain. The study aim is to determine the level of association between brain uptake of [18Ffluemetamol (from analysis of PET images) and brain amyloid content as assessed by histochemistry, immunohistochemistry and ELISA (on corresponding post-mortem brain tissue).

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  10/H0502/23

• Date of REC Opinion

  31 Mar 2010

• REC opinion

  Further Information Favourable Opinion