RecruitingPhase 2NCT07334912

AEF0217 in Participants With Down Syndrome

A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase 2b Trial to Assess the Efficacy, Safety and Tolerability of AEF0217 for 24 Weeks in Adults and Older Adolescents With Down Syndrome.


Sponsor

Aelis Farma

Enrollment

188 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 16 YearsMax Age: 32 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AEF0217 100 µg, a drug called AEF0217 300 µg, and others for people with down syndrome (trisomy 21). The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAEF0217 100 µg

Sachet of granules

DRUGAEF0217 300 µg

sachet of granules

DRUGPlacebo

sachet of matching placebo granules


Locations(10)

CHU de Bordeaux

Bordeaux, France

Genetics department, Hospices Civils de Lyon

Lyon, France

Service Génétique Médicale, CHU de Montpellier

Montpellier, France

Genetics department, Institut Jérôme Lejeune

Paris, France

Service de Génétique, Chromosomique et Moléculaire, Chu de Saint Etienne

Saint-Etienne, France

IRCCS Istituto Delle Scienze Neurologiche, Azienda Unita Sanitaria Locale Di Bologna

Bologna, Italy

Centro di Medicina dell'Invecchiamento, Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

UOR of Neurofarmacology and Translational Neurosciences, Associazione Oasi Maria S.S.Onlus

Troina, Italy

Integrative Pharmacology and Systems Neurosciences, Hospital del Mar Research Institute

Barcelona, Spain

Servicio de Medicina Interna, Hospital Universitario De La Princesa

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT07334912


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