Phase 2b Study of AEF0217 for 24 Weeks to Improve Daily Life and Cognitive Function in Adults and Older Teens With Down Syndrome

What this Trial Is About

Researchers are evaluating the effects of AEF0217 on adaptive behaviors in adults and older adolescents with Down Syndrome. This Phase 2B trial aims to determine if daily AEF0217 over 24 weeks improves daily life activities, cognitive functions including fluid and crystallized cognition, quality of life, and sleep. The safety of AEF0217 is also being studied by comparing three different doses to a placebo. Participants will be randomly assigned to receive one of three doses of AEF0217 or a placebo daily for 24 weeks. The study includes multiple visits initial baseline visits, follow-ups at weeks 1, 2, 4, 8, 12, 18, 24, and a final follow-up at week 32. After 24 weeks, those who complete treatment may join a 12-month open-label extension trial. Safety assessments include blood and urine tests, while efficacy is measured through adaptive behavior, cognition, sleep, and quality of life evaluations. Participants will attend six clinic visits accompanied by a caregiver to complete tablet-based tests and questionnaires. Phone calls will be made five times during the study to check wellbeing. Researchers will monitor vital signs, laboratory values, and adverse events throughout the trial. The total participation period ranges up to 36 weeks including follow-up. An independent safety committee will review safety data to ensure participant protection during the study.

AEF0217 in Participants With Down Syndrome