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Showing 1-20 of 102 trials
NCT05638412
In this study, investigators will study the impact of a 1:1 caregiver coaching intervention using the JASPER (Joint Attention, Symbolic Play, Engagement, Regulation) behavioral therapy curriculum compared to a psychoeducational curriculum that will be provided to caregivers for self-directed learning. Investigators want to determine the impact of both interventions on the child's development and behavior, and caregiver implementation of strategies.
NCT07413224
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 what they experienced or observed, in an exploratory manner. This qualitative study collects information through a specific questionnaire developed for this purpose.
NCT04726241
This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.
NCT07296861
The goal of this project is to evaluate an adapted health promotion program, HomeGrown, designed to improve the health of young children with Down syndrome by supporting families in making healthy home environmental changes. There is a significant need for evidence-based programs that address healthy eating and physical activity within this population, as most existing interventions have been developed for typically developing children. By tailoring the program to the unique needs of families of young children with Down syndrome, this project aims to advance inclusion and equity in health behavior promotion. This R61/R33 study will assess the feasibility (R61 Phase) and subsequent efficacy (R33 Phase) of the HomeGrown program in improving family practices related to nutrition and physical activity. During the R61 feasibility phase, 38 primary caregivers of children aged 2-6 years with Down syndrome will be enrolled in a 6-month randomized controlled trial. Families will be randomized 1:1 to either the HomeGrown intervention or a waitlist control group (6-month delayed start), stratified by the child's biological sex (male/female) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up. The R61 feasibility phase will address three specific aims: Accrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase. Engagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale. Data Collection \& Retention: Achieve at least 80% retention with completion of all outcome assessments. By addressing key gaps in nutrition and physical activity research for young children with Down syndrome, this study has the potential to improve health outcomes for an underserved population and inform future clinical and community health promotion efforts.
NCT03914625
This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.
NCT04811534
According to data from French congenital malformation registries, the prevalence of Down Syndrome (DS) in 2017 (live births and medical termination of pregnancy (MToP)) in Reunion Island was the lowest in France (23.04 per 10,000 births), notably in relation to a young maternal age. However, if we look at live births, Reunion Island has the highest prevalence of DS in France (12.24 vs. 5.81 per 10,000 births), despite a well organized prenatal diagnosis (PND). In fact, the use of MToP in this context is the lowest in France (10.8 vs 26.3 per 10 000 births). Local specificities may have an impact on the choice of patients to undergo or not undergo a MToP in the context of PND of DS and explain why the rate of recourse to MToP is the lowest in France. To date, no qualitative study exploring the reasons why women and their partners do not undergo a MToP in the context of DS has been conducted in Reunion Island. Thus, the main hypothesis is that the low recourse to MToP following PND of DS in Reunion Island could be explained by the beliefs, values or choices of Reunion Island women and their partners during pregnancy in relation to a specific family, socio-cultural and economic context.
NCT04854122
Work capacity is an important predictor of declining health or physical function, and of mortality, and is commonly measured as peak oxygen consumption. Peak oxygen consumption is very low in individuals with Down syndrome, the most prevalent genetic cause of intellectual disability. Previous research suggests individuals with Down syndrome may experience a double disadvantage when they are exercising: they may not be able to increase cardiac output sufficiently and they may not be able to allocate adequate blood flow to the working muscles. The aim of this research proposal is therefore to investigate the responses in central and peripheral blood flow regulation and cardiac autonomic function to exercise training in individuals with DS. Additionally the effects of exercise on gait, balance and attitude towards exercise in individuals with DS are investigated.
NCT07195253
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. In children, OSA can have long-term consequences on the development and on the cardiovascular system. Down Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study by Fauroux et al. (2024), OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting the need to develop new strategies to prevent and to screen OSA early in infancy. OSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly. The primary objective of the present study is to explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS. The main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance. Data from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.
NCT03233646
This study aims to develop and evaluate biomarkers using non-invasive optical coherence tomography (OCT) and OCT angiography (OCTA) as well as ultra-widefield (UWF) fundus photography to assess the structure and function of the retinal and choroidal microvasculature and structure in persons with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), Parkinson's Disease (PD), or other neurodegenerative disease, diseases as outlined.
NCT07366593
Baseline serum IgG, IgA, IgM (nephelometry), total WBC count (automated analyzer), RR (manual count), and SaO2 (pulse oximetry) were measured. Pearson or Spearman correlations were used to assess relationships between immune and respiratory variables, and with age
NCT07213063
Purpose: This study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study. Who can participate: People with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian. What participants will do: Take creatine (3 g/day) and HMB (3 g/day) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers. Timing: All tests and blood samples are taken before and after each 8-week period. Importance: Results will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.
NCT07234695
The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease. Patients will be randomly assigned to one of two groups: one group will receive the active drug (levetiracetam), and the other will receive a placebo. Both groups will receive the treatment for 96 weeks. Each patient will participate for a total of 2 years and 5 months.
NCT05144373
Infants with Down syndrome show significant delays and weaknesses in motor, cognitive, and language development compared to typically developing infants. This project aims to examine the developmental cascade effects of specific gross and fine motor experience on motor, cognitive and language development in infants with Down syndrome. We propose that both gross and fine motor experience will facilitate cognitive and language development in infants with Down syndrome, and particularly, fine motor experience will help advance gesture and early words production.
NCT06206824
Leucettinib-21 First-in-Human Phase 1 Study in 6 Parts: Single (Part 1 and 5) and Multiple (Part 3 and 6) Ascending Doses, and Food-Effect (Part 2) in Healthy Subjects, and Single Dose (Part 4) in People with Down Syndrome (DS) and Alzheimer's Disease (AD). For Parts 1, 3, 4, 5 and 6, safety and tolerability of an oral administration of Leucettinib-21 will be assessed as primary objectives. Pharmacokinetics and pharmacodynamic biomarkers will be investigated as secondary objectives. For Part 2, the effect of high fat meal will be evaluated on the pharmacokinetics parameters after an oral administration of Leucettinib-21.
NCT07260136
The study aims to determine the prevalence,clinical presentations and radiographic cervical spine abnormalities associated Down syndrome in children at sohag university hospital
NCT07248267
This randomized clinical trial investigates the effects of Vojta therapy on functional mobility and gait parameters in children with down syndrome. The study involves 28 male and female children aged 2-10 years old, who will be randomly assigned to one of the two groups i.e. control and experimental group. Key performance outcomes -GMFM 88 and gait outcome assessment -will be assessed both before and after the intervention. The research aims to evaluate the effects of vojta therapy on functional mobility and gait parameters in children with down syndrome. This RCT study will examine the potential key parameters of gait I.e. its spacial parameters that are step length, stride length, stride width, In and out toe and BOS and functional mobility Data will be analyzed through SPSS version 27.00.
NCT07244133
This randomised clinical trial investigates the effects of powerball using static and dynamic surface on upper limb Endurance and coordination in children with Down Syndrome. The study involves 28 children with Down Syndrome aged 6-10 years, will be randomly assigned one of the two groups for 3 week intervention period. Power ball training 3 sessions per week with the duration of 30 mins each session. Group A will receive different upper extremity activities with power ball on static surface while Group B will receive same activities with power ball on dynamic surface using a BOSU ball. The whole session followed by warm up and cool down sessions for 5 minutes each. Endurance will be assessed through ABIL-HAND kids tool. To access the coordination BOT-2 subsets test will be used. Data will be assessed using SPSS 27.0.
NCT06911944
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. The main questions it aims to answer are: Does donanemab reduce amyloid in the brain? Is donanemab safe and well-tolerated in people with Down syndrome? Researchers will compare donanemab to a placebo (a look-alike substance that contains no drug) to see if donanemab works to reduce levels of amyloid in the brain. Participants in the study will be 35-50 years old and will be in the study for 12 months. Participants will then stay in the study for an additional 12 months in an long-term extension where all participants will receive donanemab. Participants who had a reduction in amyloid (measured by amyloid brain scan) by the end of the first 12 months will receive placebo for the long-term extension, while participants who did not have an amyloid reduction will receive study donanemab for the long-term extension. Everyone (participants and study staff) will remain blinded to treatment for the duration of the study. Participants will: * Have intravenous (IV) infusions of donanemab (or placebo) every 4 weeks * Visit the clinic once every other month for checkups and tests. These tests will include brain scans (magnetic resonance imaging \[MRI\] and positron emission tomography \[PET\] ), blood draws and memory tests. * Have a study partner who who can provide information about the participant and can join participant for some of the study visits.
NCT05332912
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 perspective taking and performing complex spatial tasks such as wayfinding and environmental learning. A weakness in spatial abilities may have many direct applications to daily life, ranging from activities such as tying shoes to using hand tools and navigating the environment. Spatial abilities also serve as a cognitive foundation for many other complex skills such as solving mathematical problems and using spatial language for giving and receiving directions. Moreover, spatial abilities are used in a variety of specialty jobs such as grocery stocking, packaging, and assembling, which are among the most commonly reported jobs for adults with DS. Hence, a new focus on spatial ability and its modifiability in persons with DS is clearly warranted. The primary goal of the research proposed in this application is to evaluate the malleability of mental rotation and perspective taking in people with DS through providing intentional experience with numerous spatial activities. Two groups of participants will be tested over the course of the project: adolescents and young adults with DS and typically developing (TD) children. Following an initial evaluation of performance on the two abilities, participants will receive up to eight sessions of spatial activity experience utilizing puzzle construction, block building, and computer search tasks. Following the experience sessions, spatial abilities of participants will be re-evaluated. These data will be used to investigate two specific aims. First, the researchers investigate whether spatial abilities of persons with DS can be modified by experience with spatial activities. Second, the researchers investigate whether the degree of modification observed for persons with DS can reduce performance differences between them and TD children. The researchers also consider whether performance on the PPVT, Raven's matrices, and Chronological Age are associated with any benefits from spatial ability experience.
NCT03771469
This will be a prospective validation study of a sample of consecutive pediatric Down syndrome patients who are seen through the weekly Down syndrome clinic at OHSU/Doernbecher's. Questionnaires will be administered to approximately 5 new patients per month. Since this population has a higher prevalence of OSA than the general pediatric population, and OSA is a potentially modifiable determinant of quality of life, validated instruments are critical in assessing disease burden and response to treatment.