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ClinicalTrials.gov 21 recruiting now official registry

Down Syndrome clinical trials

Every US clinical trial registered for Down Syndrome — phase mix, recruiting status, and the sponsors running them, straight from the NIH ClinicalTrials.gov registry.

55 US clinical trials · 21 currently recruiting

The research picture

Down Syndrome has 55 registered US clinical trials, 21 of them open to new participants right now — about 38% of the total.

21
recruiting participants now
38%
of trials open to enrollment
5
in Phase 3–4 (later-stage)
3
top sponsor: Sequenom

Counts reflect the public ClinicalTrials.gov registry as last mirrored by PlainTrial. Status and phase are reported by each study's sponsor. This is reference information, not medical advice.

Active & Recent Trials

RECRUITING 100,000 participants

DS-Connect®: The Down Syndrome Registry

University of Colorado, Denver

NCT01950624

RECRUITING 2,500 participants

The Human Trisome Project

University of Colorado, Denver

NCT02864108

RECRUITING 2,000 participants

Specimen Collection from Pregnant Women At Increased Risk for Fetal Aneuploidy

Sequenom

NCT01429389

RECRUITING 1,000 participants

Patterns of Neurodevelopmental Disorders

Richard Frye

NCT06213090

RECRUITING 700 participants

Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy

National Institute of Allergy and Infectious Diseases (NIAID)

NCT07416201

RECRUITING Phase 2 461 participants

A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)

National Cancer Institute (NCI)

NCT04546399

RECRUITING 450 participants

Trial-Ready Cohort-Down Syndrome (TRC-DS)

University of Southern California

NCT04165109

RECRUITING NA 376 participants

Physical Activity and Community EmPOWERment Project

University of North Carolina, Chapel Hill

NCT06740162

RECRUITING 330 participants

A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia

Children's Oncology Group

NCT05702645

RECRUITING NA 303 participants

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)

Oregon Health and Science University

NCT05508971

RECRUITING Phase 2 230 participants

Down Syndrome Obstructive Sleep Apnea

Brigham and Women's Hospital

NCT06043440

RECRUITING Phase 4 100 participants

Evaluating Treatment of ADHD in Children with Down Syndrome

Children's Hospital Medical Center, Cincinnati

NCT04219280

RECRUITING NA 86 participants

PAP for Children With DS and OSAS

University of Miami

NCT04132999

RECRUITING NA 81 participants

Brain Outcomes With Lifestyle Change in Down Syndrome

University of Kansas Medical Center

NCT05985486

RECRUITING NA 60 participants

Measuring Aided Language Development

University of Central Florida

NCT06512168

RECRUITING NA 60 participants

Gamma Frequency Stimulation in Individuals With Down Syndrome

Massachusetts Institute of Technology

NCT05196984

RECRUITING NA 40 participants

Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia

University of Michigan

NCT05527652

RECRUITING Phase 2 36 participants

Medications for Obstructive Sleep Apnea to Improve Cognition in Children With Down Syndrome

University of Arizona

NCT05933603

RECRUITING NA 30 participants

How Simplified Language Affects Comprehension and Learning in Young Children With Down Syndrome

Michigan State University

NCT06951516

RECRUITING NA 20 participants

Sleep Intervention and Quality of Life in Down Syndrome

University of Alabama at Birmingham

NCT06783725

RECRUITING NA 6 participants

Harness-based Mobility Intervention for Infants With Down Syndrome

Boston University Charles River Campus

NCT06219863

ACTIVE NOT RECRUITING Phase 3 9,350 participants

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma

Children's Oncology Group

NCT01190930

ACTIVE NOT RECRUITING Phase 3 6,720 participants

A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia

National Cancer Institute (NCI)

NCT03914625

ACTIVE NOT RECRUITING Phase 3 280 participants

Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome

Children's Oncology Group

NCT02521493

ACTIVE NOT RECRUITING 202 participants

Evaluating Cognitive Outcomes in Down Syndrome

Children's Hospital Medical Center, Cincinnati

NCT04208685

ACTIVE NOT RECRUITING NA 81 participants

Validation of Sleep Questionnaires in the Down Syndrome Population

Oregon Health and Science University

NCT03771469

ACTIVE NOT RECRUITING Phase 2 66 participants

Therapies for Down Syndrome Regression Disorder

University of Colorado, Denver

NCT05662228

ACTIVE NOT RECRUITING NA 60 participants

Proactive Speech and Language Intervention for Infants With Down Syndrome

Arizona State University

NCT06450509

ACTIVE NOT RECRUITING NA 57 participants

Investigating the Impact of JASPER Behavioral Therapy in Children With Down Syndrome

Boston Children's Hospital

NCT05638412

ACTIVE NOT RECRUITING Phase 3 57 participants

Effects of Hypoglossal Nerve Stimulation on Cognition and Language in Down Syndrome and Obstructive Sleep Apnea

Inspire Medical Systems

NCT04801771

ACTIVE NOT RECRUITING Phase 2 20 participants

Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition

Vanderbilt University Medical Center

NCT05231798

ACTIVE NOT RECRUITING NA 19 participants

Transcranial Photobiomodulation With Near-Infrared Light for Language in Individuals With Down Syndrome

Massachusetts General Hospital

NCT04668001

COMPLETED 3,062 participants

Clinical Evaluation of the SEQureDx T21 Test In High Risk Pregnancies

Sequenom

NCT01555346

COMPLETED 2,502 participants

Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

Sequenom

NCT00971334

COMPLETED 760 participants

Expanded Noninvasive Genomic Medical Assessment: The Enigma Study

Progenity

NCT02787486

COMPLETED 273 participants

Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)

Carelon Research

NCT05312177

COMPLETED 257 participants

Down Syndrome Metabolic Health Study

Children's Hospital of Philadelphia

NCT01821300

COMPLETED Phase 2 160 participants

Down Syndrome Memantine Follow-up Study

University Hospitals Cleveland Medical Center

NCT02304302

COMPLETED NA 155 participants

A Bicycle Training Intervention

University of Michigan

NCT02046889

COMPLETED Phase 2 109 participants

Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.

Life Molecular Imaging

NCT00928304

COMPLETED 90 participants

A Non-Drug Study of The Suitability of Neurocognitive Tests And Functioning Scales For The Measurement of Cognitive And Functioning Changes in Individuals With Down Syndrome

Hoffmann-La Roche

NCT01580384

COMPLETED NA 44 participants

Strategies for Teaching Verbs

Vanderbilt University Medical Center

NCT03441685

COMPLETED 43 participants

Neurocognitive and Psychosocial Outcomes in Survivors of Childhood Leukemia With Down Syndrome

St. Jude Children's Research Hospital

NCT02859389

COMPLETED NA 42 participants

A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea

Christopher Hartnick, M.D.

NCT02344108

COMPLETED Phase 1 35 participants

A Study of RG1662 in Individuals With Down Syndrome

Hoffmann-La Roche

NCT01436955

COMPLETED NA 28 participants

Oxygen Uptake Kinetics During Submaximal Exercise in Adults With Down Syndrome

University of Nevada, Las Vegas

NCT05995223

COMPLETED Phase 2 22 participants

Medications for Obstructive Sleep Apnea In Children With Down Syndrome

University of Arizona

NCT04115878

COMPLETED Phase 1 20 participants

Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome

AC Immune

NCT02738450

COMPLETED NA 19 participants

Relationship Between Down Syndrome (DS) and Alzheimer's Disease (AD)

St. Joseph's Hospital and Medical Center, Phoenix

NCT02759887

COMPLETED NA 18 participants

Investigating Trunk Control in Young Children With Down Syndrome

Texas Woman's University

NCT03544840

COMPLETED NA 13 participants

Parents as the Primary Sexuality Educators for Their Young Adults With Down Syndrome

Wake Forest University Health Sciences

NCT03135236

COMPLETED NA 12 participants

Treatment Trial of Subclinical Hypothyroidism in Down Syndrome

Children's Hospital of Philadelphia

NCT01832753

COMPLETED 12 participants

Down Syndrome Biomarker Initiative (DSBI)

Michael Rafii

NCT02141971

COMPLETED NA 8 participants

Balance Bike Training in Down Syndrome

University of Mississippi Medical Center

NCT03677245

COMPLETED NA 5 participants

Feasibility and Dose Tolerability of HD-tDCS in Healthy Adults and Children With Down Syndrome

University of Wisconsin, Madison

NCT02481765

Phase Distribution

PhaseTrial count
Phase 1 2
Phase 2 8
Phase 3 4
Phase 4 1

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Down Syndrome Trial Landscape

ClinicalTrials.gov lists 55 US studies indexed under Down Syndrome, and 21 of those are currently open to recruitment — roughly 38% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Down Syndrome shows 5 late-stage studies (Phase 3 and Phase 4 combined) alongside 10 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Down Syndrome is led by Sequenom with 3 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 55 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Down Syndrome?

PlainTrial tracks 55 US clinical trials for Down Syndrome, of which 21 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Down Syndrome?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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