This study is looking at Down syndrome, a genetic condition that can affect learning, behavior, and thinking abilities. The treatment being tested is called AEF0217, which is an oral solution that is taken by mouth. Some people in the study will receive AEF0217 at different dose levels, while others will receive placebo. The medication works as a CB1 signaling specific inhibitor, which means it affects certain signals in the brain that may influence behavior and thinking.
The purpose of the study is to find out which doses of AEF0217 given over 24 weeks can help improve daily living skills and behaviors compared to placebo, and to see how these effects develop over time and whether they differ based on age, level of disability, certain genes, and blood levels of specific substances at the start of the study. The study will also look at whether the treatment can improve thinking skills, language abilities, quality of life, and sleep, and will check if the treatment is safe and well tolerated.
The study will last for 32 weeks in total. During the first 24 weeks, participants will take either AEF0217 or placebo every day. Throughout the study, participants will have regular visits where different tests and questionnaires will be done to measure changes in adaptive behaviors, which are the everyday skills needed for living independently, as well as thinking abilities, language skills, quality of life, mood, anxiety, and sleep quality. Safety will be monitored throughout the study by checking vital signs like blood pressure and heart rate, doing blood and urine tests, and performing heart monitoring tests. After the 24 weeks of treatment, there will be an additional 8-week period to continue monitoring participants.
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