8 recruiting, 4 not yet recruiting, 2 enrolling by invitation, 1 completed. 2 Not applicable, 2 Phase 2, 1 Phase 3, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 2 | Not yet recruiting 1, Recruiting 1 |
| Phase 2 | 2 | Not yet recruiting 1, Recruiting 1 |
| Phase 3 | 1 | Recruiting 1 |
| Phase 4 | 1 | Not yet recruiting 1 |
Follow Down Syndrome (Trisomy 21): new trials by email Literature Review of Down Syndrome (Trisomy 21) trials Research Report on Down Syndrome (Trisomy 21)
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome CURAPROX pacifier use, Pacifier diary, Polysomnography (PSG) to explore OSA - Obstructive Sleep Apnea, Down Syndrome (Trisomy 21) | Not applicable | Not yet recruiting | Hospices Civils de Lyon | 50 | 2026-11-02 | 2026-10-07 |
| An Open-Label Phase II Feasibility Study for the Use of Ublituximab in Adults With Down Syndrome Regression Disorder Ublituximab - Down Syndrome Regression Disorder (DSRD), Down Syndrome (Trisomy 21) | Phase 2 | Not yet recruiting | Jonathan Santoro | 20 | 2026-10-01 | 2026-09-23 |
| Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation Donanemab, Placebo - Down Syndrome (DS), Down Syndrome (Trisomy 21) | Phase 4 | Not yet recruiting | Michael Rafii, MD, PhD | 60 | 2026-08-01 | 2026-05-15 |
| The Neurocognitive Bases of Trust in Intellectual Disability Confidence adjustment assessment, clinical assessment, Cognitive assessment - Down Syndrome (Trisomy 21), Fragile X Syndrome (FXS) | Recruiting | Hospices Civils de Lyon | 112 | 2026-07-17 | 2026-08-05 | |
| Vascular Function in Adults With Down Syndrome Down Syndrome (Trisomy 21) | Recruiting | University of Nevada, Las Vegas | 46 | 2026-04-09 | 2026-10-02 | |
| Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome Polysomnography (PSG) to explore OSA, Oro-myo-functional clinical evaluation, Sleep Disturbance Scale for Children - Obstructive Sleep Apnea, Down Syndrome (Trisomy 21) | Recruiting | Hospices Civils de Lyon | 30 | 2026-04-01 | 2026-04-03 | |
| Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD) | Recruiting | Healing Hope International | 100 | 2026-03-01 | 2026-03-25 | |
| Qualitative Effects of AEF0217 in Down Syndrome People Down Syndrome (Trisomy 21) | Enrolling by invitation | Aelis Farma | 28 | 2026-03-01 | 2026-04-08 | |
| The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment Pregnant Individuals, Aneuploidy | Recruiting | BillionToOne Inc. | 1000 | 2026-01-10 | 2026-10-15 | |
| AEF0217 in Participants With Down Syndrome AEF0217 100 µg, AEF0217 300 µg, Placebo - Down Syndrome (Trisomy 21) | Phase 2 | Recruiting | Aelis Farma | 188 | 2025-12-22 | 2026-04-08 |
| LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome Levetiracetam 500mg, Placebo - Down Syndrome, Down Syndrome (DS) | Phase 3 | Recruiting | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | 120 | 2025-12-22 | 2026-01-12 |
| Neuropsychological Evaluation in Intellectual Disability (ENDI) ENDI (Neuropsychological Evaluation in Intellectual Disability) - Down Syndrome (Trisomy 21), Neuropsychology | Not yet recruiting | Central Hospital, Nancy, France | 40 | 2025-07-01 | 2025-07-02 | |
| Relationship Between Eating Patterns, Body Composition and the Detection of Fatty Liver in Children and Adolescents With Trisomy 21: LiverTy Project To evaluate fat liver content in the cases/controls population. - Obesity Prevention, Pediatric Obesity | Enrolling by invitation | IMDEA Food | 34 | 2025-03-01 | 2025-05-02 | |
| Sleep Intervention and Quality of Life in Down Syndrome Mindfulness-Based Therapy for Insomnia, Wait-list control - Down Syndrome, Down Syndrome (Trisomy 21) | Not applicable | Recruiting | University of Alabama at Birmingham | 20 | 2025-03-01 | 2026-03-20 |
| Non-Invasive Determination of Fetal Chromosome Abnormalities Down Syndrome (Trisomy 21), Edward's Syndrome (Trisomy 18) | Unknown | Lenetix Medical Screening Laboratory | 1000 | 2009-01-01 | 2009-05-01 | |
| Non-Invasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker Down Syndrome (Trisomy 21), Edwards Syndrome (Trisomy 18) | Completed | Sequenom, Inc. | 1000 | 2008-06-01 | 2010-01-06 |
Down Syndrome (16) · Alzheimer Disease (3) · Trisomy 13 Syndrome (3) · Trisomy 18 Syndrome (3) · DiGeorge Syndrome (2) · Fragile X Syndrome (2) · Sleep Apnea Syndromes (2) · Sleep Apnea, Obstructive (2) · Aneuploidy (1) · Autism Spectrum Disorder (1) · Brain Injuries, Traumatic (1) · Cerebral Palsy (1) · Chromosome Aberrations (1) · Cognitive Dysfunction (1) · Congenital Abnormalities (1)
Abnormalities, Multiple (16) · Chromosome Disorders (16) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (16) · Nervous System Diseases (16) · Neurobehavioral Manifestations (16) · Neurologic Manifestations (16) · Congenital Abnormalities (15) · Genetic Diseases, Inborn (15) · Intellectual Disability (15) · Mental Disorders (6) · Pathological Conditions, Signs and Symptoms (6) · Brain Diseases (4) · Cardiovascular Abnormalities (4) · Cardiovascular Diseases (4) · Central Nervous System Diseases (4)
Polysomnography (2) · Functional Status (1) · Levetiracetam (1) · Mental Status and Dementia Tests (1) · Neuropsychological Tests (1) · Population Control (1) · donanemab (1) · ublituximab (1)
Hospices Civils de Lyon (3) · Aelis Farma (2) · BillionToOne Inc. (1) · Central Hospital, Nancy, France (1) · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (1) · Healing Hope International (1) · IMDEA Food (1) · Jonathan Santoro (1) · Lenetix Medical Screening Laboratory (1) · Michael Rafii, MD, PhD (1) · Sequenom, Inc. (1) · University of Alabama at Birmingham (1) · University of Nevada, Las Vegas (1)
United States (7) · France (5) · Spain (4) · Italy (1)
Allan Bombard, MD (1) · Caroline G Richter, PhD (1) · Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP (1) · Jonathan Santoro, MD (1) · Julia Wynn, MS, MS, CGC (1) · Michael Rafii, MD, PhD (1) · Pier Vincenzo Piazza, MD, PhD (1) · Stephen A Brown, MD (1)
2025 (1), R33AG066543 (1)