Clinical trials: Trisomy 21
Sleep Apnea, Obstructive, Down Syndrome
A Pilot Study to Evaluate the Hypoglossal Nerve Stimulator in Adolescents With Down Syndrome and Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) affects up to 1% of the general pediatric population and is associated with adverse behavior and quality of life, as well as long term cardiopulmonary system complications.
- Trial name
- NCT02344108
- Testing
- Inspire® Upper Airway Simulation System (Model 3028 IPG )
- Where
- 5 sites in United States
- Volunteers
- 42 people
- Sponsor
- Christopher Hartnick, M.D.
Down Syndrome, Mild Cognitive Impairment
Nicotine Treatment of Cognitive Decline in Down Syndrome
This study will ascertain whether nicotine is safe and tolerable in DS patients, help with dose-ranging of nicotine in DS, look for evidence of enhancements in cognitive functioning, and establish evidence for biological and…
- Trial name
- NCT01778946
- Testing
- Low Dose Nicotine (7mg), Moderate Dose Nicotine (14mg)
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Vanderbilt University Medical Center
Acute Myeloid Leukemia Post Cytotoxic Therapy, Myelodysplastic Syndrome Post Cytotoxic Therapy
Highest Dose of Uproleselan in Combination With Fludarabine and Cytarabine for Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Mixed Phenotype Acute Leukemia Relapsed or Refractory That Expresses E-selectin Ligand on the Cell Membrane
This phase I trial tests the safety, side effects, and determination of the best dose of uproleselan in combination with fludarabine and cytarabine in treating patients with acute myeloid leukemia, myelodysplastic syndrome or…
- Conditions
- Acute Myeloid Leukemia Post Cytotoxic Therapy, Myelodysplastic Syndrome Post Cytotoxic Therapy, Myeloid Leukemia Associated With Down Syndrome, Recurrent Acute Myeloid Leukemia
- Trial name
- NCT05146739
- Testing
- Cytarabine, Fludarabine, Leucovorin
- Where
- 19 sites in United States
- Volunteers
- 8 people
- Sponsor
- National Cancer Institute (NCI)
Down Syndrome
Assessing Malleability of Spatial Abilities in Down Syndrome
Based on available literature and our own preliminary research, the researchers have concluded that persons with Down syndrome (DS) exhibit difficulties in utilizing the specific spatial abilities of mental rotation and…
- Trial name
- NCT05332912
- Testing
- Spatial Ability Experience
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- University of Alabama, Tuscaloosa
Down Syndrome, Trisomy 21
Down Syndrome Metabolic Health Study
The purpose of this research study is to determine which measures best capture cardiovascular disease (CVD) risk and type 2 diabetes (T2DM) risk in children and adolescents with Down syndrome (DS).
- Trial name
- NCT01821300
- Where
- 2 sites in United States
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Down Syndrome, Depression
Fluoxetine Treatment of Depression in Down Syndrome
The purpose of the study is to do a preliminary assessment of whether fluoxetine is effective, safe, and tolerable for the treatment of depression in adults with Down syndrome.
- Trial name
- NCT05458479
- Testing
- Fluoxetine
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Massachusetts General Hospital
Respiratory Syncytial Virus Infection
Synagis® Liquid 50mg, 100mg for Intramuscular Injection Special Investigation in Immunocompromised Children With Synagis®
This post marketing observational study (PMOS) was conducted in Japan during the 2013-2014 and 2014-2015 Respiratory Syncytial Virus (RSV) seasons to assess the safety and effectiveness of palivizumab for the prevention of…
- Trial name
- NCT02016690
- Volunteers
- 312 people
- Sponsor
- AbbVie
Down Syndrome
An Online Health Tool About Down Syndrome: Down Syndrome Clinic to You
The investigators conducted a national two-arm, randomized controlled trial of caregivers of individuals with DS to assess the efficacy of DSC2U in assuring adherence to evidence-based guidelines.
- Trial name
- DSC2U (NCT04227197)
- Testing
- Down Syndrome Clinic to You (DSC2U)
- Where
- United States
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Hypothyroidism, Trisomy 21
Use of Liquid Stable Levothyroxine in Trisomy 21 Pediatric Patients
Children with levothyroxine (T21) have developmental delay and other functional gastrointestinal (GI) issues that may negatively affect L-T4 tolerability and absorption.
- Trial name
- NCT04747275
- Testing
- Liquid stable levothyroxine (L-T4) Tirosint-SOL, Oral tablet levothyroxine (L-T4)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Children's Mercy Hospital Kansas City
Down Syndrome, Alzheimer Disease
The Promotion of Physical Activity for the Prevention of Alzheimer's Disease in Adults With Down Syndrome
The objectives of this study are to determine the feasibility and potential efficacy of remotely delivered group exercise sessions to increase daily moderate to vigorous physical activity in adults with Down syndrome, relative to…
- Trial name
- NCT04048759
- Testing
- Remote Low, Remote High, Personal Coach
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- University of Kansas Medical Center
Down Syndrome, Trisomy 21
Use of Partial Body Weight Support Play Environment to Encourage Mobility and Exploration in Infants With Down Syndrome
To explore the effects of Partial Body Weight Support (PBWS) within an enriched play environment for infants with Down Syndrome (DS), who are not yet walking, to better understand how PWBS may impact their mobility; exploration…
- Trial name
- NCT05307523
- Testing
- Enriched Play Environment with Partial Body Weight Support Harness, Enriched Play Environment without Partial Body Weight Support Harness
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- University of Washington
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
The purpose of this study is to measure the safety, PK, occurrence of ADA to nirsevimab, and anti-RSV neutralizing Ab in Japanese children with certain health conditions or pre-term infants aged ≤12 months.
- Trial name
- JUBILUS (NCT06042049)
- Testing
- Nirsevimab
- Where
- 9 sites in Japan
- Volunteers
- 33 people
- Sponsor
- AstraZeneca
Vision, Low
Spectacles for Patients With Down Syndrome
This study tests the hypothesis that objectively derived spectacle prescriptions based on wavefront aberration measurements of the eyes of individuals with Down syndrome can provide an improvement in visual acuity over that…
- Trial name
- NCT03367793
- Testing
- Spectacles - Clinically Derived, Spectacles - Metric Technique #1 Derived, Spectacles - Metric Technique #2 Derived
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Houston
Down Syndrome, Amyloid Beta-protein
Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.
To determine the sensitivity of the visual assessment of BAY94-9172 PET images in detecting cerebral β-amyloid in individuals with Down Syndrome (DS) and specificity in individuals without DS.
- Trial name
- NCT00928304
- Testing
- Florbetaben (BAY94-9172)
- Where
- 2 sites in United States
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Lantheus Biosciences Ltd.
Down Syndrome
Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride.
- Trial name
- NCT00675025
- Testing
- Donepezil hydrochloride (Aricept)
- Where
- 31 sites in United States
- Volunteers
- 117 people
- Sponsor
- Eisai Inc.
Down Syndrome
Efficacy and Safety of Memantine Hydrochloride in Enhancing the Cognitive Abilities of Young Adults With Down Syndrome
The purpose of this 16-week research study is to determine whether a drug called memantine hydrochloride (memantine) has the potential to help improve memory and other cognitive abilities of young adults with Down syndrome (DS).
- Trial name
- NCT01112683
- Testing
- Memantine
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- University of Colorado, Denver
Down Syndrome, Physical Inactivity
Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome
The investigators are assessing acceptability, appropriateness, and feasibility of an remote choreographed exercise intervention using validated scales alongside qualitative data among young adults with Down Syndrome.
- Trial name
- DANCE-DS (NCT06537648)
- Testing
- Decreasing Alzheimer's Risk Through oNline Choreographed Exercise - Down Syndrome Program
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Kansas Medical Center
Down Syndrome
Blood Flow Regulation in Individuals With Down Syndrome - Training Study
Work capacity is an important predictor of declining health or physical function, and of mortality, and is commonly measured as peak oxygen consumption.
- Trial name
- NCT04854122
- Testing
- Combined exercise intervention
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Nevada, Las Vegas
Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma
Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma
This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute…
- Conditions
- Acute Lymphoblastic Leukemia, Adult B Lymphoblastic Lymphoma, Ann Arbor Stage I B Lymphoblastic Lymphoma, Ann Arbor Stage II B Lymphoblastic Lymphoma
- Trial name
- NCT01190930
- Testing
- Cyclophosphamide, Cytarabine, Dexamethasone
- Where
- 243 sites in United States, Australia and 5 more
- Volunteers
- 9,350 people
- Sponsor
- Children's Oncology Group
Acute Myeloid Leukemia, Down Syndrome
Response-Based Chemotherapy in Treating Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome in Younger Patients With Down Syndrome
This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome.
- Conditions
- Acute Myeloid Leukemia, Down Syndrome, Myelodysplastic Syndrome, Myeloid Leukemia Associated With Down Syndrome
- Trial name
- NCT02521493
- Testing
- Asparaginase, Asparaginase Erwinia chrysanthemi, Cytarabine
- Where
- 191 sites in United States, Australia and 4 more
- Volunteers
- 280 people
- Sponsor
- Children's Oncology Group