5 completed, 5 recruiting, 4 terminated, 2 active not recruiting. 17 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 5, Recruiting 5, Terminated 4, Active not recruiting 2, Unknown 1 |
| Phase 2 | 2 | Completed 1, Recruiting 1 |
Follow Down Syndrome: new trials by email Literature Review of Down Syndrome trials Research Report on Down Syndrome
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 |
|---|---|---|---|---|---|---|
| Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome Cold Stress, Maximal Dynamic Exercise, Isometric Handgrip Exercise with Post-Exercise Muscle Ischemia - Down Syndrome, Autonomic Dysfunction | Phase 3 | Recruiting | University of Colorado, Denver | 200 | 2026-04-06 | 2026-10-13 |
| 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 |
| Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome Epi-ON corneal cross-linking (CXL) - Down Syndrome (DS), Keratoconus | Phase 3 | Recruiting | Woolfson Eye Institute | 225 | 2025-08-01 | 2026-02-02 |
| The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia 4 chemotherapy blocks: Course 1 AIE (cytarabine/idarubicin/etoposide), Course 2 AI (cytarabine/idarubicin), Course 3 HAD (high-dose cytarabine (1g)/daunorubicin), Course 4 HA (high-dose cytarabine). - AML (Acute Myelogenous Leukemia), Down Syndrome (DS) | Phase 3 | Recruiting | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | 100 | 2025-07-24 | 2025-11-20 |
| LIFE-DSR-Biomarker Sub-study of Biomarkers in Down Syndrome Related Alzheimer's Disease (DS-AD) [18F]MK-6240 - Down Syndrome | Phase 3 | Terminated | LuMind IDSC Foundation | 5 | 2023-06-27 | 2025-03-06 |
| Blood Flow and Blood Pressure Investigation in Down Syndrome Exercise - Down Syndrome | Phase 3 | Completed | University of Illinois at Chicago | 48 | 2022-09-01 | 2024-04-18 |
| GnRH Therapy on Cognition in Down Syndrome GnRH, gonadorelin acetate, 0.9% NaCl - Down Syndrome, Cognitive Decline | Phase 2 / Phase 3 | Recruiting | Nelly Pitteloud | 56 | 2020-08-27 | 2024-02-12 |
| A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia Asparaginase Erwinia chrysanthemi, Blinatumomab, Cyclophosphamide - B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma | Phase 3 | Active not recruiting | National Cancer Institute (NCI) | 6720 | 2019-07-03 | 2026-10-01 |
| Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome Asparaginase, Asparaginase Erwinia chrysanthemi, Cytarabine - Acute Myeloid Leukemia, Down Syndrome | Phase 3 | Active not recruiting | Children's Oncology Group | 280 | 2015-12-23 | 2026-08-19 |
| Efficacy Assessment of Systematic Treatment With Folinic Acid and Thyroid Hormone on Psychomotor Development of Down Syndrome Young Children thyroid hormone and folinic acid - Down Syndrome | Phase 3 | Completed | Institut Jerome Lejeune | 175 | 2012-04-02 | 2020-05-13 |
| Preimplantation Genetic Diagnosis (PGD) by Array Comparative Genome Hybridization (CGH) and Blastocyst Biopsy Preimplantation Genetic Diagnosis - Infertility, Miscarriage | Phase 3 | Terminated | Reprogenetics | 120 | 2011-04-01 | 2012-05-30 |
| Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma Cyclophosphamide, Cytarabine, Dexamethasone - Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma | Phase 3 | Completed | Children's Oncology Group | 9350 | 2010-08-11 | 2026-05-28 |
| Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Aricept (donepezil hydrochloride), Placebo - Down Syndrome, Cognitive Dysfunction | Phase 3 | Terminated | Eisai Inc. | 8 | 2008-09-01 | 2018-04-23 |
| Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Aricept (Donepezil hydrochloride), Placebo - Down Syndrome, Cognitive Dysfunction | Phase 3 | Terminated | Eisai Inc. | 9 | 2008-09-01 | 2020-01-28 |
| Vitamin E in Aging Persons With Down Syndrome Vitamin E, multivitamin, Placebo - Down Syndrome, Alzheimer Disease | Phase 3 | Unknown | New York State Institute for Basic Research | 350 | 2002-04-01 | 2012-05-04 |
| Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome folinic acid - Down Syndrome | Phase 2 / Phase 3 | Completed | Institut Jerome Lejeune | 120 | 2000-10-01 | 2009-12-17 |
| Multicenter Vitamin E Trial in Aging Persons With Down Syndrome Alpha-Tocopherol, Sugar Pill - Alzheimer's Disease, Down Syndrome | Phase 3 | Completed | New York State Institute for Basic Research | 349 | 2000-09-01 | 2012-05-09 |
Alzheimer Disease (4) · Cognitive Dysfunction (4) · Dementia (2) · Leukemia, Myeloid, Acute (2) · Motor Activity (2) · Precursor B-Cell Lymphoblastic Leukemia-Lymphoma (2) · Abortion, Spontaneous (1) · Burkitt Lymphoma (1) · Corneal Diseases (1) · Epilepsy (1) · Epilepsy, Tonic-Clonic (1) · Infertility (1) · Keratoconus (1) · Myelodysplastic Syndromes (1)
Abnormalities, Multiple (17) · Chromosome Disorders (17) · Congenital Abnormalities (17) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (17) · Genetic Diseases, Inborn (17) · Intellectual Disability (17) · Nervous System Diseases (17) · Neurobehavioral Manifestations (17) · Neurologic Manifestations (17) · Mental Disorders (6) · Neurocognitive Disorders (6) · Brain Diseases (4) · Central Nervous System Diseases (4) · Cognition Disorders (4) · Hematologic Diseases (4)
Cytarabine (4) · Leucovorin (4) · Thioguanine (3) · Asparaginase (2) · Calcium Dobesilate (2) · Cyclophosphamide (2) · Daunorubicin (2) · Dexamethasone (2) · Donepezil (2) · Doxorubicin (2) · Etoposide (2) · Mercaptopurine (2) · Methotrexate (2) · Vincristine (2) · Vitamin E (2)
Children's Oncology Group (2) · Eisai Inc. (2) · Institut Jerome Lejeune (2) · New York State Institute for Basic Research (2) · Federal Research Institute of Pediatric Hematology, Oncology and Immunology (1) · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (1) · LuMind IDSC Foundation (1) · National Cancer Institute (NCI) (1) · Nelly Pitteloud (1) · Reprogenetics (1) · University of Colorado, Denver (1) · University of Illinois at Chicago (1) · Woolfson Eye Institute (1)
United States (10) · Australia (4) · Canada (4) · New Zealand (3) · Puerto Rico (3) · France (2) · Switzerland (2) · Ireland (1) · Peru (1) · Russia (1) · Saudi Arabia (1) · Spain (1) · United Kingdom (1)
Thomas McRae, MD (2) · Anne L Angiolillo (1) · Arthur J Dalton, PhD (1) · Clotilde Mircher, MD (1) · Henri Blehaut, M.D. (1) · Howard F. Andrews, Ph.D. (1) · Jason N Berman (1) · Mary C Sano, PhD (1) · Mary C. Sano, Ph.D. (1) · Nelly Pitteloud, MD (1) · Paul S Aisen, MD (1) · Paul S. Aisen, M.D. (1) · Robert Motl, Ph.D. (1)
PMID 20084109, PMID 31281181, PMID 33411585, PMID 33844429, PMID 34863019, PMID 36048943, PMID 37890117, PMID 39121442, PMID 39625363, PMID 39651791, PMID 40315406, PMID 40588365, PMID 41124669
U10CA180886 (3), R01AG016381 (2), T32AG000279 (1), U10CA098543 (1)