About the Down Syndrome Study
What is the purpose of the study?
The Compose study (Cognition and Memory in People with Down Syndrome) is a clinical study that will assess the safety and potential efficacy of a compound that could enhance cognitive function in people with Down syndrome. The compound is well understood and has been in use for a variety of conditions for decades.
More specifically the Study will look at the potential of a compound to improve memory, language, and learning. The Compose Study could lead to development of a product that may significantly improve the quality of life for people with Down syndrome.
Who else is involved in this research?
The clinical study is based on research conducted by Stanford University at the Down Syndrome Research Center, and was initially funded by the LuMind Foundation, a foundation founded by parents of children with Down syndrome in the San Francisco Bay Area.
Ongoing work has the backing of the USA Government through the National Institute of Health (USA), which has provided funding grants to support additional development.
- 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 an investigational drug
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.