GE-067-005 18F Phase 3 Study

• Research type

  Research Study

• Full title

  A Principal Open-label Study to Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects with Amnestic Mild Cognitive Impairment who will Convert to Probable Alzheimer's Disease.

• IRAS ID

  22449

• Contact name

  Richard Perry

• Eudract number

  2009-010227-62

• ISRCTN Number

  not issued

• Research summary

  This study will involve subjects who have been diagnosed with amnestic Mild Cognitive Impairment (aMCI). The study aims to usfluemetamol (18F), an investigational drug, to predict which patients will experience a more rapid conversion to probable Alzheimer's Disease (pAD) based on the uptake in the brainfluemetamol (18F) is designed as a marker for detecting beta-amyloid plaques in the brain. The uptake will be measured using an image taken using a Positron Emission Tomography (PET) scanner. The images will be reviewed by five independent readers who will not have access to the subject's medical history and diagnosis. The subject's clinician will continue to see the subject every six months for a total of three years. At each visit the clinician will perform a series of tests aimed to help assist with the diagnosis of pAD. The clinician will not have access to the PET image or interpretations until the study is complete. All subjects regardless if they have been diagnosed as having pAD will be evaluated by the Clinical Adjudication Committee (CAC). The CAC will evaluate the information and if a diagnosis of pAD is provided, the subject's participation in the study will come to an end. Eventually the study will compare the time to conversion to pAD in aMCI subjects with normal and abnormal patterns ofluemetamol (18F) uptake.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/60

• Date of REC Opinion

  9 Sep 2009

• REC opinion

  Further Information Favourable Opinion