Clinical trials: Down Syndrome (Trisomy 21), active
Down Syndrome, Trisomy 21
Executive Function Play Opportunities for Children With Down Syndrome
The Executive Function Play Opportunities (EXPO) study is a sequential, multiple assignment, randomized trial (SMART) evaluating adaptive caregiver-mediated intervention pathways for improving executive function (EF) in children…
- Trial name
- EXPO (NCT07792382)
- Testing
- EXPO, EXPO Extended, EXPO Foundations
- Where
- 2 sites in United States, Italy
- Volunteers
- 150 people
- Sponsor
- Colorado State University
Pregnant Individuals, Aneuploidy
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
The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of…
- Conditions
- Pregnant Individuals, Aneuploidy, Down Syndrome (Trisomy 21), 22q11.2 Deletion Syndrome
- Trial name
- ADVANCE (NCT07643896)
- Where
- 9 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- BillionToOne Inc.
Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome
Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals.
- Trial name
- TET21 (NCT07658053)
- Testing
- CURAPROX pacifier use, Pacifier diary, Polysomnography (PSG) to explore OSA
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Hospices Civils de Lyon
Down Syndrome (Trisomy 21)
Vascular Function in Adults With Down Syndrome
Adults with Down syndrome (Ds) are often thought to have a lower risk of heart and blood vessel disease because they tend to have lower blood pressure (BP) and fewer heart attacks than people without Ds.
- Trial name
- VDS (NCT07630207)
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- University of Nevada, Las Vegas
Down Syndrome Regression Disorder (DSRD), Down Syndrome (Trisomy 21)
An Open-Label Phase II Feasibility Study for the Use of Ublituximab in Adults With Down Syndrome Regression Disorder
The goal of this clinical trial is to evaluate whether the monoclonal antibody ublituximab can treat Down Syndrome Regression Disorder (DSRD) by assessing its safety, tolerability, and preliminary efficacy in affected…
- Conditions
- Down Syndrome Regression Disorder (DSRD), Down Syndrome (Trisomy 21), Neuroinflammatory / Neuropsychiatric Disorder
- Trial name
- NCT07812181
- Testing
- Ublituximab
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Jonathan Santoro
Obstructive Sleep Apnea, Hypertonia, Muscle
Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia
The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).
- Conditions
- Obstructive Sleep Apnea, Hypertonia, Muscle, Nasal Airway Obstruction, Tolerance
- Trial name
- NCT05527652
- Testing
- Self-Supporting Nasopharyngeal Airway (ssNPA)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Down Syndrome (Trisomy 21), Fragile X Syndrome (FXS)
The Neurocognitive Bases of Trust in Intellectual Disability
This project studies the neurocognitive basis of trust adjustment in intellectual disability (ID), a source of significant vulnerability for these patients, focusing on two target populations chosen for their specific social…
- Trial name
- BNConfDI (NCT07434037)
- Testing
- Confidence adjustment assessment, clinical assessment, Cognitive assessment
- Where
- France
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Down Syndrome, Down Syndrome, Partial Trisomy 21
Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition
Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated.
- Conditions
- Down Syndrome, Down Syndrome, Partial Trisomy 21, Alzheimer Disease
- Trial name
- NCT05231798
- Testing
- [18F]-FEOBV Radiotracer
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
Down Syndrome (DS), Down Syndrome (Trisomy 21)
Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation
The goal of this clinical trial is to learn if donanemab can reduce levels of amyloid in the brain, and if donanemab is safe and well-tolerated in participants with Down syndrome.
- Conditions
- Down Syndrome (DS), Down Syndrome (Trisomy 21), Alzheimer Disease, Amyloid Beta Protein
- Trial name
- ALADDIN (NCT06911944)
- Testing
- Donanemab
- Volunteers
- 60 people
- Sponsor
- Michael Rafii, MD, PhD
Down Syndrome (Trisomy 21)
AEF0217 in Participants With Down Syndrome
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.
- Trial name
- NCT07334912
- Testing
- AEF0217 100 µg, AEF0217 300 µg
- Where
- 10 sites in France, Italy and 1 more
- Volunteers
- 188 people
- Sponsor
- Aelis Farma
Down Syndrome (Trisomy 21)
Qualitative Effects of AEF0217 in Down Syndrome People
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…
- Trial name
- NCT07413224
- Where
- Spain
- Volunteers
- 28 people
- Sponsor
- Aelis Farma
Obstructive Sleep Apnea, Down Syndrome (Trisomy 21)
Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome
Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals.
- Trial name
- OMF21 (NCT07195253)
- Testing
- Polysomnography (PSG) to explore OSA, Oro-myo-functional clinical evaluation, Sleep Disturbance Scale for Children
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Hospices Civils de Lyon
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program.
- Conditions
- Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD), Neurodevelopmental Disorders and Developmental Abnormalities, Developmental Delay (Disorder)
- Trial name
- GEN-HOPE (NCT07493096)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Healing Hope International
Down Syndrome, Down Syndrome (Trisomy 21)
Sleep Intervention and Quality of Life in Down Syndrome
Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS).
- Trial name
- SleepDS (NCT06783725)
- Testing
- Mindfulness-Based Therapy for Insomnia, Wait-list control
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Alabama at Birmingham
Diastolic Dysfunction, Neonatal Encephalopathy
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined…
- Conditions
- Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn
- Trial name
- DiFuSE (NCT06200519)
- Where
- Ireland
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- University College Cork
Down Syndrome, Down Syndrome (DS)
LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome
The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome.
- Conditions
- Down Syndrome, Down Syndrome (DS), Down Syndrome (Trisomy 21), Alzheimer Dementia
- Trial name
- LESS-AD (NCT07234695)
- Testing
- Levetiracetam 500mg
- Where
- 5 sites in Spain
- Volunteers
- 120 people
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Down Syndrome, Trisomy 21
The Human Trisome Project
The Human Trisome Project will significantly increase the speed of Down syndrome research and the understanding of associated medical conditions. Its biobank will provide de-identified samples to research.
- Trial name
- HTP (NCT02864108)
- Where
- United States
- Volunteers
- 2,500 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Chromosomal Aneuploidies (e.g., Trisomy 21, Trisomy 18, Trisomy 13); Prenatal Screening Accuracy
Evaluation of Fetal Bladder Emptying During the 11-14 Weeks' Ultrasound Examination as a Negative Predictive Marker for Chromosomal Abnormalities
Template-Based Brief Summary (Sağlık Profesyonelleri İçin) Study Title: The Negative Predictive Value of First-Trimester Fetal Bladder "Rapid Emptying" (≤40 minutes and post-void ≤2 mm) for Major Chromosomal Aneuploidies: A…
- Trial name
- NCT07165743
- Testing
- 40-Minute Real-Time First-Trimester Ultrasonography
- Where
- Turkey (Türkiye)
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Haseki Training and Research Hospital
Down Syndrome (Trisomy 21), Neuropsychology
Neuropsychological Evaluation in Intellectual Disability (ENDI)
The goal of this observational study is to evaluate the acceptability ofpatients with trisomy 21 (T21) to perform the full battery of ENDI neurospychological tests and each of the subsets.
- Conditions
- Down Syndrome (Trisomy 21), Neuropsychology, Cognitive Aging, Alzheimer Disease
- Trial name
- ENDI (NCT07047963)
- Testing
- ENDI (Neuropsychological Evaluation in Intellectual Disability)
- Where
- France
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Central Hospital, Nancy, France
Periodontitis, Trisomy 21
Periodontitis and Inflammation in Children With Down Syndrome/Trisomy 21: Study on Biological Samples
Since 2018, the Chicago Classification of Periodontal Diseases and Conditions, has listed Down syndrome (DS)/trisomy 21 (T21) as a systemic disease with periodontal implications.
- Trial name
- NT21 (NCT05970965)
- Testing
- Biological sampling
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris