Safety, blood levels and effects of RO5186582; version 1
Research type
Research Study
Full title
A multi-center, randomized, double-blind, placebo-controlled, multiple dose study to investigate safety and tolerability of RO5186582 in individuals with Down Syndrome; HMR code 11-503.
IRAS ID
92848
Contact name
Frans van den Berg
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd
Eudract number
2011-002110-37
Clinicaltrials.gov Identifier
Research summary
The study medicine is called RG1662. It’s an experimental new treatment that we hope will improve attention and memory in people with Down Syndrome.
We’ll test if the study medicine has any important side effects, and see how much study medicine gets into the bloodstream, and how long the body takes to get rid of it. We’ll see if our tests show any improvement in memory and attention. We’ll also study if genes (pieces of DNA) affect how the body responds to or handles the study medicine.
The participants will be 33-44 men or women with Down Syndrome. They’ll be aged 18 – 30 years, and each participant will take the study medicine twice daily for 35 – 38 days. The participants will be split into 3 groups of 11, and each group will take a different dose level of the study medicine. 3 members of each group will take ‘dummy’ and 8 will take ‘real’ study medicine. Neither the participants nor the study doctors will know which treatment the participant is taking.
Participants will take up to 16 weeks to finish the study. They may stay on the ward for 1 night at the start of the study (but they could stay at home or in a hotel if they preferred), and make 7 outpatient visits during the study.
A pharmaceutical company (Roche) is paying for the study.
The study is being done in several countries. In the UK, it will be done at an independent research centre in London. Two NHS psychiatrists will recruit participants with Down Syndrome. They’ll do this by referring to a database, contacting Down Syndrome charities and attending Down Syndrome networking events for psychiatrists.
REC name
London - Harrow Research Ethics Committee
REC reference
11/LO/1953
Date of REC Opinion
10 Feb 2012
REC opinion
Further Information Favourable Opinion