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NCT07334912
AEF0217 in Participants With Down Syndrome
Phase 2 trial testing AEF0217 100 µg in Down Syndrome (Trisomy 21) in 188 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Aelis Farma |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 188 |
| Start date | 22 December 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2027 |
| Sites | 10 locations across France, Spain, Italy |
Drugs / interventions tested
- AEF0217 100 µg — full drug profile →
- AEF0217 300 µg — full drug profile →
- Placebo
Conditions studied
- Down Syndrome (Trisomy 21) — all drugs for Down Syndrome (Trisomy 21) →
Sponsor
Aelis Farma — full company profile →
Who can join
Adults 16 to 32, any sex, with Down Syndrome (Trisomy 21). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is to identify if AEF0217 show an improvement in adaptive behaviors (daily life activities) in adults and older adolescents with Down Syndrome. It will also learn about the safety of AEF0217. The main questions it aims to answer are: * Does AEF0217 improve the daily life activities of the participants after being administered daily for 24 weeks ? * Does AEF0217 improve fluid cognitive function (cognitive abilities that do not depend on prior knowledge) and the crystallised one (knowledge acquired through one's culture, including verbal ability and social knowledge), the quality of life and sleep of the participants after being administered daily for 24 weeks ? * What medical problems do participants have when taking AEF0217? Researchers will compare 3 doses of AEF0217 to a placebo (a look-alike substance that contains no drug) to see if AEF0217 improves adaptative behaviours in people with Down Syndrome. Participants will: * Take AEF0217 or a placebo every day for 24 weeks * Visit the clinic 6 times with their caregiver for checkups, performing tests on a tablet and answering questionnaires. * Be called by phone at home 5 times to check that they are well.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07334912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Down Syndrome (Trisomy 21)
Currently open trials in the same condition.
- NCT07195253 — Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome · recruiting
- NCT07493096 — Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disor · recruiting
- NCT06783725 — Sleep Intervention and Quality of Life in Down Syndrome · NA · recruiting
Other Aelis Farma trials
Trials by the same sponsor.
- NCT05451017 — The Effect of Food on the Oral Bioavailability of AEF0117 in Healthy Volunteers · Phase 1 · terminated
- NCT05554926 — Study of [4-14C] AEF0117 Following a Single Oral Dose in Healthy Male Subjects · Phase 1 · completed
- NCT05748405 — Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome · Phase 1, PHASE2 · completed
- NCT05322941 — Effect of AEF0117 on Treatment-seeking Patients With Cannabis Use Disorder (CUD) · Phase 2 · completed
- NCT05170737 — AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjec · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07334912 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aelis Farma
- Last refreshed: 8 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07334912.
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