NCT07413224

Qualitative Effects of AEF0217 in Down Syndrome People

Qualitative Evaluation of Perceived Effects Elicited by AEF0217 in Individuals With Down Syndrome

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 28 (estimated)
• Sponsor: Aelis Farma · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Following the AEF0217-102 trial (NCT05748405), which investigated the effects of AEF0217 versus placebo, participants with Down syndrome and their caregivers who took part in the trial are invited to share their perceptions of what they experienced or observed, in an exploratory manner. This qualitative study collects information through a specific questionnaire developed for this purpose.

Detailed description

This is a non-interventional, follow-up, cross-sectional, mixed-methods (qualitative and quantitative) study. Participants and their caregivers who will be enrolled are those who have received either AEF0217 or placebo and who have completed the previous trial. The participant and their cargiver will be contacted prospectively to assess their interest in participating in the study. The participant and their caregiver will sign an electronic informed consent form and will receive a link to a questionnaire developed using EU Survey to be completed. Data will be collected at a single time point but may refer retrospectively to past experiences related to the previous trial. Data from all participants and caregivers who complete the questionnaire will be included in the analysis. Given the observational and descriptive nature of the study, the quantitative analysis will be primarily descriptive. The study will be conducted in accordance with the ethical principles derived from the Declaration of Helsinki (75th General Assembly, Helsinki, Finland, October 2024). In addition, the study will be conducted in compliance with the protocol, Regulation (EU) 2016/679 (General Data Protection Regulation, GDPR), and the regulatory requirements applicable at the study site.

Conditions

• Down Syndrome (Trisomy 21)

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-02-17
• Last updated: 2026-04-08

Locations

1 site across 1 country: Spain