Down Syndrome Clinical Research Study in Australia

A compound in a medicine used for decades, may improve learning for people with Down syndrome

The Compose study (Cognition and Memory in People with Down Syndrome) is seeking interest from families who have children with Down Syndrome who would like to know about a new nationwide clinical trial being conducted to determine whether a medication called BTD-001 can improve memory, language, attention and learning in people with Down Syndrome.

What is BTD-001?

BTD-001 is a form of a drug product approved and used widely in many countries around the world from the 1920’s until the 1980’s to treat respiratory conditions and senile dementia (memory loss in the elderly).

In this clinical study, BTD-001 will be given at lower doses than those used in the past. Past use of higher doses was considered generally safe and well tolerated. The potential efficacy of BTD-001 in Down syndrome is supported by strong scientific evidence.

Why participate?

•  Contribute to finding a treatment that may improve cognition and quality of life for people with Down syndrome.

•  Have accurate and meaningful diagnostic information.

•  Gain early access to a product not otherwise available.

•  Receive medical care and attention as part of the clinical study.

•  Help evaluate the safety and potential efficacy of BTD-001.

What are the criteria for participation?

•  Person with Down syndrome age 13 to 35 years old.

•  Stable medical condition.

•  Parent, guardian or carer who will accompany the participant to all visits and be able to report changes in speech, behavior, and activities of daily living.

•  Other specific criteria to be discussed with the clinic by phone or at the screening visit.

What will happen during the study?

•  There will be 6 clinic visits over a 16 week period.

•  On all visits a full physical examination and a review of health status will be conducted. On some visits, additional general health measures such as blood tests and electrocardiograms (measure of heart health) will be performed.

•  On some visits, tests that measure cognitive skills such as memory and language tests will be taken. Parents or carers will be interviewed or asked to complete questionnaires about communication, daily living and social skills.

•  On some visits, electrical activity in the brain in response to sounds will be measured.

•  Visits that include cognitive testing will take about 6 hours in the clinic. Other visits will take about 2 hours.

•  Travel costs will be reimbursed.

Further information is available at: www.compose21.com

People who are interested can also call 1300 659 729 to confirm their eligibility.