DS102:

Clinical study DS102 is enrolling individuals with Down syndrome ages 13 to 35 in Australia. This study involves standard safety assessments which include physical and neurological exams, blood tests, and adverse event monitoring. Preliminary efficacy will be evaluated through measures of cognitive and functional performance which include tests of memory, language and electrical responses of the brain to sound. Parents or carers will be interviewed or asked to complete questionnaires about communication, daily living and social skills. This study is an important first step in developing a drug that could improve cognition and quality of life for people with Down syndrome.

Summary:

• Randomized, double blind, placebo-controlled, parallel group
• Planned 90 subjects with confirmed Down syndrome ages 13 to 35
• Small molecule product administered orally
• 12 week treatment period with a 4 week follow-up
• Screening and 6 clinic visits