Safety and imaging of Florbetapir in individuals with MCI

• Research type

  Research Study

• Full title

  A longitudinal, open label, multicenter study, evaluating the safety and imaging characteristics of Florbetapir 18F (18F-AV-45) in individuals with new onset mild cognitive impairment (MCI)

• IRAS ID

  82865

• Contact name

  Richard James Perry

• Sponsor organisation

  Avid Pharmaceutical

• Eudract number

  2011-001625-24

• ISRCTN Number

  not known

• Research summary

  Alzheimer??s Disease (AD) is the most common cause of dementia in the elderly, affecting approximately 7.3 million people in Europe. Diagnosis and treatment of the disease have been hampered by the absence of reliable non-invasive markers for the underlying pathology. The main purpose of this study is to find better ways to evaluate the cause of mild thinking and memory problems using a new type of brain scan using a specialist scanner called a PET (Positron Emission Tomography) scanner. The use of a new radioactive tag will be tested which can stick to certain deposits in the brain that can be detected by the PET scanner.Patients with new onset mild cognitive impairment will be enrolled in one group receiving a 370 MBq bolus injection of florbetapir 18F followed by 10 minutes continuous PET imaging. Patients will be in the study for up to 25 months (24 months after PET imaging). The trial funded by Avid Pharmaceutical Inc. Approximately 200 patients are to be entered in this study across different countries including: France, Italy, Netherlands, Spain and Switzerland.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/1198

• Date of REC Opinion

  19 Sep 2011

• REC opinion

  Further Information Favourable Opinion