19 completed. 19 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 19 | Completed 19 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 1 | Completed 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 |
|---|---|---|---|---|---|---|
| Therapies for Down Syndrome Regression Disorder Lorazepam, Intravenous immunoglobulin (IVIG), Tofacitinib - Down Syndrome, Regression | Phase 2 | Completed | University of Colorado, Denver | 66 | 2023-06-29 | 2026-09-03 |
| Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome Placebo, AEF0217 - Down Syndrome | Phase 1 / Phase 2 | Completed | Aelis Farma | 40 | 2022-12-15 | 2024-10-10 |
| Dilated Versus Non-Dilated Wavefront Corrections for Patients With Down Syndrome Dilated Refraction, Non-Dilated Refraction - Down Syndrome, Refractive Errors | Phase 2 | Completed | Ohio State University | 42 | 2022-05-06 | 2026-05-08 |
| Medications for Obstructive Sleep Apnea In Children With Down Syndrome Atomoxetine and oxybutynin (ato-oxy) - Obstructive Sleep Apnea, Down Syndrome | Phase 2 | Completed | University of Arizona | 22 | 2020-10-21 | 2025-08-19 |
| Tofacitinib for Immune Skin Conditions in Down Syndrome Tofacitinib - Down Syndrome, Alopecia Areata | Phase 2 | Completed | University of Colorado, Denver | 47 | 2020-10-21 | 2025-12-11 |
| Building Sentences With Preschoolers Who Use AAC AAC Generative Language Intervention, Standard of Care / Business as Usual - Down Syndrome, Speech and Language Disorder | Phase 2 | Completed | University of Central Florida | 70 | 2018-05-11 | 2024-01-08 |
| The Effects of Inhalational Anaesthetics in Cognitive Functions in Down Syndrome Patients Sevoflurane, Desflurane - Down Syndrome | Phase 2 | Completed | Asklepieion Voulas General Hospital | 39 | 2016-12-01 | 2020-06-09 |
| the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome cerebrolysin - Down Syndrome | Phase 2 | Completed | Mansoura University Children Hospital | 64 | 2016-09-30 | 2021-02-11 |
| Down Syndrome Memantine Follow-up Study Memantine, Placebo - Down Syndrome, Intellectual Disability | Phase 2 | Completed | University Hospitals Cleveland Medical Center | 160 | 2014-10-01 | 2023-06-27 |
| A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) Placebo, RG1662 - Down Syndrome | Phase 2 | Completed | Hoffmann-La Roche | 173 | 2014-05-05 | 2017-10-25 |
| A Double-blind, Placebo-controlled Comparative Study and Open-label Extension Study to Confirm the Efficacy and Safety of E2020 in Subjects With Down Syndrome Having Regression Symptoms and Disabled Activities of Daily Living. E2020-Donepezil hydrochloride, Placebo - Down Syndrome | Phase 2 | Completed | Eisai Co., Ltd. | 36 | 2013-09-12 | 2017-08-22 |
| A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia ELND005, Placebo - Down Syndrome | Phase 2 | Completed | OPKO Health, Inc. | 23 | 2013-09-01 | 2019-11-04 |
| Nicotine Treatment of Cognitive Decline in Down Syndrome Low Dose Nicotine (7mg), Moderate Dose Nicotine (14mg) - Down Syndrome, Mild Cognitive Impairment | Phase 1 / Phase 2 | Completed | Vanderbilt University Medical Center | 7 | 2013-04-01 | 2022-05-10 |
| Normalization of dyrk1A and APP Function as an Approach to Improve Cognitive Performance and Decelerate AD Progression in DS Subjects: Epigallocatechin Gallate as Therapeutic Tool Epigallocatechin-3-gallate (EGCG) - Down Syndrome (DS) | Phase 2 | Completed | Parc de Salut Mar | 87 | 2012-02-01 | 2016-02-11 |
| Egcg, a dyrk1a Inhibitor as Therapeutic Tool for Reversing Cognitive Deficits in Down Syndrome Individuals. Epigallocatechin-3-gallate (EGCG), Placebo - Down Syndrome | Phase 2 | Completed | Parc de Salut Mar | 31 | 2010-05-01 | 2013-03-13 |
| Rivastigmine Study in Adolescents With Down Syndrome Rivastigmine, Liquid Placebo - Down Syndrome | Phase 1 / Phase 2 | Completed | Duke University | 42 | 2009-11-01 | 2015-04-06 |
| Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid. Florbetaben (BAY94-9172) - Down Syndrome, Amyloid Beta-protein | Phase 2 | Completed | Lantheus Biosciences Ltd. | 109 | 2009-06-01 | 2014-03-05 |
| Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (HCl) (Aricept) In Treating Cognitive Dysfunction Exhibited By Children With Down Syndrome Donepezil HCl, Placebo - Down Syndrome | Phase 2 | Completed | Eisai Inc. | 129 | 2007-11-16 | 2021-04-19 |
| 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 |
Alzheimer Disease (2) · Autoimmune Diseases (2) · Alopecia Areata (1) · Autoimmune Diseases of the Nervous System (1) · Catatonia (1) · Cognitive Dysfunction (1) · Dementia (1) · Dermatitis, Atopic (1) · Eczema (1) · Hidradenitis Suppurativa (1) · Inflammation (1) · Intellectual Disability (1) · Language Disorders (1) · Plaque, Amyloid (1)
Abnormalities, Multiple (19) · Chromosome Disorders (19) · Congenital Abnormalities (19) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (19) · Genetic Diseases, Inborn (19) · Nervous System Diseases (19) · Neurobehavioral Manifestations (19) · Neurologic Manifestations (19) · Intellectual Disability (18) · Pathological Conditions, Signs and Symptoms (5) · Mental Disorders (4) · Signs and Symptoms (3) · Behavior (2) · Brain Diseases (2) · Central Nervous System Diseases (2)
epigallocatechin gallate (2) · tofacitinib (2) · 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene (1) · Atomoxetine Hydrochloride (1) · Commerce (1) · Desflurane (1) · Donepezil (1) · Immunoglobulins, Intravenous (1) · Leucovorin (1) · Lorazepam (1) · Memantine (1) · Nicotine (1) · Rivastigmine (1) · Sevoflurane (1) · Standard of Care (1)
Parc de Salut Mar (2) · University of Colorado, Denver (2) · Aelis Farma (1) · Asklepieion Voulas General Hospital (1) · Duke University (1) · Eisai Co., Ltd. (1) · Eisai Inc. (1) · Hoffmann-La Roche (1) · Institut Jerome Lejeune (1) · Lantheus Biosciences Ltd. (1) · Mansoura University Children Hospital (1) · OPKO Health, Inc. (1) · Ohio State University (1) · University Hospitals Cleveland Medical Center (1) · University of Arizona (1)
United States (12) · Spain (3) · France (2) · Argentina (1) · Brazil (1) · Canada (1) · Egypt (1) · Greece (1) · Italy (1) · Japan (1) · Mexico (1) · New Zealand (1) · Singapore (1) · United Kingdom (1)
Joaquin Espinosa, PhD (2) · Alberto C Costa, MD, PhD (1) · Alexander C Conley, PhD (1) · Clotilde Mircher, MD (1) · Daniel Combs, MD (1) · Elise Sannar, MD (1) · Emmanouil Gkliatis, MD (1) · George Capone, MD (1) · Heather Anderson, OD, PhD (1) · Henri Blehaut, M.D. (1) · Jonathon Santoro, MD (1) · Paul A Newhouse, MD (1) · Priya Kishnani, MD (1)
PMID 20084109, PMID 27302362, PMID 28453471, PMID 33773598, PMID 34535086, PMID 34942135, PMID 35123401, PMID 37555595, PMID 38946973, PMID 39737640
R01DC016321 (1), R33AR077495 (1), R61HL151254 (1)