A PET scan study of a new test for Alzheimer's disease (version 1)

• Research type

  Research Study

• Full title

  A Single-Arm Open-Label Multi-Centre Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40 (HMR 10-020)

• IRAS ID

  68140

• Contact name

  Steve Warrington

• Sponsor organisation

  GE Healthcare

• Eudract number

  2010-023513-64

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This is a study of a new imaging test to detect a protein in the brain called beta-amyloid. People with Alzheimer’s disease have high brain levels of beta-amyloid. If there’s no beta-amyloid in the brain, doctors can be reassured that a patient doesn’t have Alzheimer’s disease. In this study, We'll test a radioactive tracer callefluemetamol (18F), which binds to beta-amyloidfluemetamol (18F) is injected and a PET (positron emission tomography) scan is used to detect it in the brainfluemetamol (18F) binds to beta-amyloid during the PET scan and ‘lights up’ the parts of the brain with beta-amyloid. We know that healthy young people (21’40 years) don’t have any beta-amyloid in the brain. We’re doing this study to prove thafluemetamol (18F) doesn’t show any beta-amyloid in the brains of healthy young people. This is a large multicentre study with up to 300 healthy volunteers (aged 21’40 years) in 15 sites in Europe and the USA. Each volunteer will participate in the study for up to 6« weeks, but usually about 1’2 weeks. They'll have 3 study visits: 2 screening visits and 1 visit for the PET scan. Each volunteer will have 1 dose of up to 20 æfluemetamol (18F) and a PET scan. The amount of radiation exposure will be 6 mSv, which is just over double the total amount of background radiation (2.7 mSv) that the average UK resident is exposed to each year. Volunteers will also have an MRI scan at screening. A pharmaceutical company (GE Healthcare Ltd) is funding the study. In the UK, the study will take place at 2 centres in London and 1 centre in Glasgow. We'll recruit healthy volunteers by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/102

• Date of REC Opinion

  3 Dec 2010

• REC opinion

  Favourable Opinion