COMPOSE - A clinical study to improve cognitive capabilities in people with Down syndrome

Dear Mark

I would be grateful if you could advise families of people with DS known to Sunnyfield about this study. I am responsible for the Univ of Sydney site.

Best wishes

Stewart Einfeld

Professor, Centre for Disability Research and Policy

Senior Scientist, Brain & Mind Research Institute

THE UNIVERSITY OF SYDNEY
T +61 2 9351 9213  
E stewart.einfeld@sydney.edu.au  | W http://sydney.edu.au/health_sciences/staff/stewart_einfeld.shtml

Subject: COMPOSE - A clinical study to improve cognitive capabilities in people with Down syndrome

We would like to ask for your assistance in letting colleagues and patients who may be interested know about a new nationwide clinical trial to determine whether a medication called BTD-001 can improve memory, language, attention and learning in people with Down syndrome.

Two sites in Sydney are involved in this study –at Neuroscience Research Australia and the University of NSW the research is being led by Professor Rhoshel Lenroot, Dr Robert Leitner and Dr Bruce Chenoweth, while at the University of Sydney the research is being led by Professor Stewart Einfeld.

Trials in an animal model of Down syndrome found that the medication helped learning and memory, and that effects lasted even after the medication was stopped.  Although there is a long history of using this same medication in people, particularly in dementia, this trial will also help to establish safety for use in people with Down syndrome.  Participants in the study take the medication or a placebo for twelve weeks, with several visits to measure its effects on cognition and monitor health.  A family member or carer would also need to attend appointments to provide information about function

As an organization working with people with intellectual disabilities, we would like to ask for your assistance in letting people know about this study through circulating information in newsletters, e-news, email updates, posting a link on your organisation’s website or facebook page, or through displaying our brochure and/or poster promoting the study (both attached; we can send hard copies of the brochure and poster upon request).

We have ethics approval from the South Eastern Sydney Local Health District (SESLHD), the University of NSW and the University of Sydney to conduct this research. If further ethics approval would be required for you to assist in advertising this study, please do contact us.

Further information is available on the study website www.compose21.com. People who are interested can also call a central number, 1300 659 729 to confirm their eligibility.

If you would like brochures or posters or to discuss this further, please contact Karen Burton, NeuRA/UNSW site coordinator on 02 9399 1882 (k.burton@neura.edu.au) or Lauren Rice, University of Sydney site coordinator on 02 9114 4106 (lauren.rice@sydney.edu.au).

Thank you for your assistance in promoting this study.