A PET study to assess brain uptake of RO5186582; ver 1

• Research type

  Research Study

• Full title

  A single-center, double blind molecular and functional imaging study to assess GABA(A)a5 receptor expression, occupancy and functional connectivity in the brains of individuals with Down Syndrome and healthy controls following a single oral administration of RO5186582 or placebo.

• IRAS ID

  106989

• Contact name

  Elizabeth Tranter

• Eudract number

  2012-001301-24

• ISRCTN Number

  n/a

• Research summary

  RO5186582 is an experimental medicine that we hope will improve memory and attention in people with Down Syndrome (DS) by blocking sites in the brain called GABA(A)a5 receptors. In healthy volunteers and DS patients: * We'll use PET (positron emission tomography) scans to measure how many GABAAa5 receptors there are and how much RO5186582 attaches to them * We'll use MRI (magnetic resonance imaging) scans to test the effect of RO5186582 on brain activity * We'll study if genes (pieces of DNA) affect how the body responds to or handles RO5186582 Up to 9 healthy volunteers and up to 8 volunteers with DS, aged 18 ?? 30, will take part. Each participant will: * have 2 study sessions, each including 1 PET scan and 1 MRI scan * take single doses of RO5186582 and placebo Before each PET scan, We'll give participants an injection of a radioactive tracer containing carbon-11; the PET scan shows where the tracer is in the brain, so we can tell where the receptor is. Each participant will be exposed to radiation similar to 1 year??s background radiation. Participants must lie still in the PET scanner for 1« h and in the MRI scanner for 30 min. Participants will take up to 15 weeks to finish the study. They??ll stay on the ward for 2 nights and make up to 4 outpatient visits (1 visit will be to a psychiatrist??s clinic). A pharmaceutical company (Roche) is paying for the study. The study is being done at 1 clinic and 1 scanning unit in London. The Mental Health Research Network will identify NHS psychiatrists to recruit DS patients (by review of records, referral from colleagues or advertising). The clinic will recruit healthy participants by advertising; by word of mouth; from volunteer databases; and via its websites.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  12/LO/0974

• Date of REC Opinion

  25 Jun 2012

• REC opinion

  Favourable Opinion