[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"down-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:down-syndrome":26},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,59,0,25,[9,43,70,98,120,143,166,196,221,249,275,302,327,353,376,413,439,469,516,542,568,593,632,655,680],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100624943","natural-history-of-dysregulation-and-aging-of-the-immune-system-in-people-with-trisomy-21-with-and-without-thymectomy-100624943",false,"NCT07416201","Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1\\. Aged \\>=1 year.\n\n2\\. Willingness to allow storage of specimens and data for future research.\n\n* Additional Inclusion Criteria for Affected Participants\n\n  1. Documented T21 based on chromosomal karyotype test.\n  2. Ability of participant or LAR to provide informed consent.\n* Additional Inclusion Criteria for Unaffected Relatives\n\n  1. Ability of participant to provide informed consent or, for individuals \\\u003C18 years of age, to provide informed assent as applicable.\n  2. Reside in the same household as the corresponding affected participant.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study.",true,"ALL","1 Year","120 Years",{"count":21,"type":22},700,"ESTIMATED","OBSERVATIONAL","Background:\n\nDown syndrome is a genetic disorder that can cause heart defects and other problems in the body. People with Down syndrome are more likely to have infections, autoimmunity, and blood diseases. Some may need surgery to treat congenital heart problems. During this surgery, doctors sometimes remove part of the thymus. The thymus is an organ that plays a role in immune function. People who have had part of their thymus removed may get sick more often than others do.\n\nObjective:\n\nThis natural history study will gather data about how removing part of the thymus affects the health of people with Down syndrome.\n\nEligibility:\n\nPeople aged 1 year and older with Down syndrome. The study will include both people who have, and those who have not had, surgery to remove part of their thymus. Healthy relatives are also needed.\n\nDesign:\n\nParticipants with Down syndrome will have clinic visits at least once a year for 15 years.\n\nAt each visit they will have a physical exam. They will give blood and stool samples. They will have tests of their heart and lung function.\n\nParticipants aged 18 years or older may have at least 1 imaging scan: They will lie on a table that slides into a donut-shaped machine. The machine uses X-rays to take pictures of the inside of the body.\n\nParticipants who have tissue samples collected from their bodies (biopsies) taken during the study may have extra tissue taken for research.\n\nHealthy relatives will also have visits once a year for 15 years. They will only have a physical exam and provide blood and stool samples.",[26],"Down Syndrome",[26,28,29],"Immunologic Deficiency Syndromes","THYMECTOMY","RECRUITING","2026-06-25",{"date":33,"type":34},"2026-06-26","ACTUAL",{"date":36,"type":34},"2026-06-23",{"date":38,"type":22},"2040-11-01",{"name":40,"class":41},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":42},"100457069","phase-2-cholinergic-integrity-in-down-syndrome-in-association-with-aging-alzheimers-disease-pathology-and-cognition-100457069","NCT05231798","Cholinergic Integrity in Down Syndrome in Association With Aging, Alzheimer's Disease Pathology, and Cognition","Inclusion Criteria:\n\n1. Diagnosis of Down syndrome (DS), including mosaic DS or partial trisomy 21.\n2. Provision of signed and dated informed consent form and if needed, assent with signed consent by a legally authorized representative (LAR).\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Male or female, aged 18-55 inclusive.\n5. In good general health as evidenced by medical history with no diagnosis of dementia.\n6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, the medical monitoring team will review on case-by-case basis to recommend timing of baseline cognitive testing\n7. Adequate visual and auditory acuity to allow neuropsychological testing\n8. For females who are not surgically sterile or post-menopausal by two years: negative pregnancy test 24 hours prior to PET scan.\n9. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, 2nd Edition)\n10. English must be first\u002Fnative language\n11. Reliable Study Partner (may be caregiver, sibling, parent) who can provide information about the subject's clinical symptoms and history\n\nExclusion Criteria:\n\n1. Any significant disease or unstable medical condition that could affect neuropsychological testing (i.e., unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI)\n3. Participants unable to complete MRI and PET procedures\n4. IQ less than 40 (as assessed by Kaufman Brief Intelligence Test, Second Edition (KBIT-2).\n5. Pregnancy, breast-feeding\n6. History within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment\n7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow-up T3\u002FT4 levels indicate that it is not physiologically significant.\n8. Clinically significant abnormalities in screening laboratories\n9. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation (e.g warfarin)\n10. Participants whom the Site PI deems to be otherwise ineligible\n11. Clinical diagnosis of dementia\n12. Concurrent participation in a clinical trial for an investigational product or concurrent participation in a longitudinal study with overlapping outcome measures\u002Fprocedures is prohibited","18 Years","55 Years",{"count":52,"type":22},30,"INTERVENTIONAL",[55],"PHASE2","Progressive age-related cognitive deficits occurring in both AD and DS have been connected to the degeneration of several neuronal populations, but mechanisms are not fully elucidated. The most consistent neuronal losses throughout the progression of AD are seen in cholinergic neurons where these losses negatively affect cognition, particularly in attention, learning, and memory formation. Evidence of reduced cholinergic integrity in DS is largely limited to animal models and post-mortem human data. The investigators propose to use molecular, functional, and structural biomarkers to assess the cholinergic integrity in adults with DS. The investigators anticipate using the data gathered in this pilot study to inform future study designs to determine AD risk stratification in DS by identifying individuals who show an accelerated decline in cholinergic integrity that correlates with cognitive and neurobehavioral changes. Also, our cholinergic biomarkers may identify whether individuals with DS are likely to respond to pro-cholinergic interventions, including the novel cholinergic modulators that are being developed to enhance cholinergic-sensitive cognitive functioning. The investigators anticipate using the data gathered here to inform future treatment studies in TRC-DS and beyond where novel cholinergic treatments may offer opportunities for early intervention in DS and be complementary to disease-modifying approaches such as anti-amyloid treatments.",[26,58,59],"Down Syndrome, Partial Trisomy 21","Alzheimer Disease","2026-06-17",{"date":62,"type":34},"2026-06-22",{"date":64,"type":34},"2021-08-19",{"date":66,"type":22},"2027-04-30",{"name":68,"class":69},"Vanderbilt University Medical Center","OTHER",{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":53,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":42},"100589215","how-simplified-language-affects-comprehension-and-learning-in-young-children-with-down-syndrome-100589215","NCT06951516","How Simplified Language Affects Comprehension and Learning in Young Children With Down Syndrome","How Single-Word and Telegraphic Simplification Affects Language Processing and Word Learning in Young Children With Down Syndrome","Inclusion Criteria:\n\n* Down syndrome\n\nEnglish as primary language\n\n2-7 years old\n\nExclusion Criteria:\n\n* Acquired brain injury\n\nCerebral palsy\n\nUncorrected vision or hearing impairment","2 Years","7 Years",{"count":52,"type":22},[81],"NA","The long-term study goal is to experimentally evaluate the components (and likely active ingredients) of early language interventions for young children with Down syndrome (DS). The overall objective is to determine how single-word and telegraphic simplification affects real-time language processing and word learning in young children with DS (relative to full, grammatical utterances). The proposed project will investigate three specific aims: 1) Determine how single-word and telegraphic simplification affects language processing. 2) Determine how single-word and telegraphic simplification affects word learning. 3) Evaluate child characteristics that may moderate the effects of linguistic simplification on language processing and word learning. Aim 1 will test the hypothesis that children with DS will process grammatical utterances faster and more accurately than telegraphic or single-word utterances. Aim 2 will test the hypothesis that overall, children will demonstrate better word learning in the grammatical compared to the single-word and telegraphic conditions. Aim 3 will test the hypothesis that receptive language and nonverbal cognitive abilities will be significant moderators, such that children with stronger linguistic and cognitive skills will show the greatest benefit from grammatical input but children with lower linguistic and cognitive scores will perform similarly across conditions.",[26],[85,86,87,88],"Down syndrome","language development","language processing","language input","2026-06-11",{"date":91,"type":34},"2026-06-12",{"date":93,"type":34},"2025-01-01",{"date":95,"type":22},"2027-05-31",{"name":97,"class":69},"Michigan State University",{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":53,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":112,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":119},"100404441","phase-2-a-study-to-compare-blinatumomab-alone-to-blinatumomab-with-nivolumab-in-patients-diagnosed-with-first-relapse-b-cell-acute-lymphoblastic-leukemia-b-all-100404441","NCT04546399","A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)","A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC# 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >\u002F= 1 to \u003C 31 Years Old With First Relapse","Inclusion Criteria:\n\n* Patients must be \\>= 1 and \\\u003C 31 years at time of enrollment\n* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:\n\n  * Isolated bone marrow relapse\n  * Isolated central nervous system (CNS) (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n  * Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testes\n* Patients with Down syndrome (DS) are eligible in the following categories:\n\n  * Isolated bone marrow relapse\n  * Combined bone marrow with CNS (excluding known optic nerve\u002Fretinal and CNS chloromas) and\u002For testicular relapse\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients =\\\u003C 16 years of age\n\n  * Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay\n* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study\n\n  * Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 expression\n  * Patients must not have had a prior hematopoietic stem cell transplant\n  * A single intrathecal chemotherapy at the time of relapse will be allowed. If \\\u003C 7 days have elapsed between this intrathecal therapy (IT) and the start of protocol therapy, then the day 1 intrathecal chemotherapy (i.e. methotrexate, cytarabine, or triple intrathecal) may be omitted\n  * In the 28 days prior to enrollment, up to five days of post-relapse, pre-enrollment therapy (steroids and\u002For hydroxyurea only) is permissible\n\n    * Patients with Down syndrome who received pre-enrollment therapy and have a white blood count (WBC) \\>= 30,000\u002Ful at the time of enrollment still must receive protocol specified cytoreductive therapy with vincristine and dexamethasone, and no \"washout\" is required\n    * Patients with Down syndrome who received pre-enrollment therapy and have a WBC \\\u003C 30,000\u002Ful at the time of enrollment must be given a 24 hour \"washout\" before starting immunotherapy\n  * Note: There is no waiting period or \"washout\" for patients who relapse while receiving upfront therapy\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \\>= 70 mL\u002Fmin\u002F1.73 m\\^2 OR a serum creatinine based on age\u002Fsex as follows (within 7 calendar days prior to enrollment):\n\n  * Age: Maximum serum creatinine (mg\u002FdL)\n\n    * 1 to \\\u003C 2 years: 0.6 (male), 0.6 (female)\n    * 2 to \\\u003C 6 years: 0.8 (male), 0.8 (female)\n    * 6 to \\\u003C 10 years: 1 (male), 1 (female)\n    * 10 to \\\u003C 13 years: 1.2 (male), 1.2 (female)\n    * 13 to \\\u003C 16 years: 1.5 (male), 1.4 (female)\n    * \\>= 16 years: 1.7 (male), 1.4 (female)\n\n      * The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the Center for Disease Control (CDC)\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by echocardiogram, cardiac magnetic resonance imaging (MRI) or radionuclide angiogram\n* No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \\> 94% if there is clinical indication for determination\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with B-lymphoblastic lymphoma (B-LLy)\n* Patients with Burkitt leukemia\u002Flymphoma or mature B-cell leukemia\n* Patients with Philadelphia chromosome positive (Ph+) B-ALL or ABL class Ph-like B-ALL (i.e. rearrangements involving ABL1, ABL2, CSF1R or PDGFRB and predicted to be sensitive to imatinib or dasatinib)\n* Patients with mixed phenotype acute leukemia (MPAL)\n* Patients with known Charcot-Marie-Tooth disease\n* Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL, regardless of blast immunophenotype\n* Patients with active, uncontrolled infection defined as:\n\n  * Positive bacterial blood culture within 48 hours of study enrollment\n  * Receiving IV or PO antibiotics for an infection with continued signs or symptoms. Note: Patients may be receiving IV or oral antibiotics to complete a course of therapy for a prior documented infection if cultures have been negative for at least 48 hours and signs or symptoms of active infection have resolved. For patients with clostridium (C.) difficile diarrhea, at least 72 hours of antibacterial therapy must have elapsed and stools must have normalized to baseline.\n  * Fever above 38.2 degrees Celsius (C) within 48 hours of study enrollment with clinical signs of infection. Fever without clinical signs of infection that is attributed to tumor burden is allowed if blood cultures are negative for \\> 48 hours\n  * A positive fungal culture within 30 days of study enrollment or active therapy for presumed invasive fungal infection\n  * Active viral or protozoal infection requiring IV treatment\n* Patients known to have one of the following concomitant genetic syndromes: Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome are not eligible.\n* Patients with uncontrolled HIV, hepatitis B, or hepatitis C infection. Of note, patients with known human immunodeficiency virus (HIV) infection on effective anti-retroviral therapy with undetectable viral load for at least the last 6 months prior to enrollment are eligible. Similarly, hepatitis B and hepatitis C positive patients who have been treated and have no viral detectable burden are also eligible\n* Patients with significant central nervous system pathology that would preclude treatment with blinatumomab, including history of severe neurologic disorder or autoimmune disease with CNS involvement\n\n  * Note: Patients with a history of seizures that are well controlled on stable doses of anti-epileptic drugs are eligible Patients with a history of cerebrovascular ischemia\u002Fhemorrhage with residual deficits are not eligible. Patients with a history of cerebrovascular ischemia\u002Fhemorrhage remain eligible provided all neurologic deficits have resolved\n* Patients with an active known\u002Fsuspected autoimmune disease are not eligible. However, patients with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll\n* Patients with DS patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are not eligible\n\n  * Note: Group 3 and 4 patients with known non-hematopoietic, non-CNS\u002Ftesticular extramedullary disease (i.e., chloromatous disease) are eligible if this is NOT the only site of relapsed disease\n* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained within 7 days prior to enrollment. Patients who are sexually active and of reproductive potential are not eligible unless they agree to use an effective contraceptive method for the duration of this study. Men with female partners of childbearing potential should use effective contraception during the duration of their treatment. The effect of blinatumomab on fertility has not been evaluated. Blinatumomab is not recommended for pregnant women or women of childbearing potential (WOCBP) not using contraception. Females of reproductive potential must use effective contraception during treatment and for at least 48 hours after the last dose of blinatumomab. Studies in animal models have shown that nivolumab can adversely impair pregnancy. Thus, nivolumab is expected to cause fetal harm during pregnancy. WOCBP receiving nivolumab must continue contraception for a period of at least 5 months after the last dose of nivolumab. It is unknown whether nivolumab is present in breast milk, thus breastfeeding should be discontinued while a patient is receiving nivolumab\n* Lactating females are not eligible unless they agree to not breastfeed their infants. It is unknown whether blinatumomab or its metabolites are excreted in human breast milk. Women are not permitted to breastfeed while receiving blinatumomab and for the last 48 hours after the last blinatumomab dose. Due to the potential for serious adverse reactions in the breastfed infant, women are not permitted to breastfeed during treatment and for 5 months after the last nivolumab dose","30 Years",{"count":107,"type":22},461,[55],"This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.",[26,111],"Recurrent B Acute Lymphoblastic Leukemia",{"date":91,"type":34},{"date":114,"type":34},"2020-12-17",{"date":116,"type":22},"2028-06-30",{"name":118,"class":41},"National Cancer Institute (NCI)",225,{"id":121,"slug":122,"hasResults":12,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":53,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":42},"100582716","tdcs-for-catatonic-depression-in-down-syndrome-a-pilot-study-100582716","NCT06866925","tDCS for Catatonic Depression in Down Syndrome: A Pilot Study","Transcranial Direct Current Stimulation as a Treatment for Depression With Catatonic Features in Patients With Down Syndrome: a Pilot Randomized Sham-controlled Study","TOTORO","Inclusion Criteria:\n\n* Patient with Down syndrome\n* Age \\> 18\n* Diagnosis of Major Depressive Disorder MDD with catatonic symptoms according to the DSM-5 criteria\n* Informed consent signed by the patient, by the patient under curatorship, or by the legal representative in the case of a patient under guardianship.\n* Person affiliated to the French social security system or equivalent\n\nExclusion Criteria:\n\n* Pregnancy (checked with a pregnancy test)\n* Contraindication for tDCS(i.e., cochlear implant)\n* Refusal of the patients or their legal representatives\n* Other persons protected under the CSP (judicial safeguard, family habilitation)",{"count":129,"type":22},62,[81],"This study evaluates the efficacy of transcranial direct current stimulation (tDCS) for depression with catatonia in individuals with Down syndrome (DS). 62 patients will be randomized to receive 15 sessions of active or sham tDCS. The primary objective is to measure changes in depressive\u002Fcatatonic symptoms using the Bush-Francis Catatonia Rating Scale (BFCRS). Secondary objectives include safety, cognitive effects, EEG correlates, and biological markers (cortisol, BDNF, cytokines). The study aims to provide a non-pharmacological therapeutic alternative for this population",[26],[134],"catatonia","2026-06-10",{"date":89,"type":34},{"date":138,"type":34},"2025-09-12",{"date":140,"type":22},"2027-09-30",{"name":142,"class":69},"Hôpital le Vinatier",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":53,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":42},"100615765","homegrown-a-family-based-lifestyle-intervention-to-support-healthy-development-of-young-children-with-down-syndrome-100615765","NCT07296861","HomeGrown: A Family-based Lifestyle Intervention to Support Healthy Development of Young Children With Down Syndrome","HomeGrown","Inclusion Criteria:\n\nAdult:\n\n* Ability to provide informed consent\n* 18 years or older\n* Primary caregiver of a child with Down syndrome aged 2 to 6 years old\n* Have access to WI-FI or smartphone\n* Be able to read and speak English\n\nChildren:\n\n* Be 2-6 years old.\n* Are diagnosed with Down syndrome\n* Are not reliant on tube feeding\n\nExclusion Criteria:\n\n\\-",{"count":151,"type":22},38,[81],"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.\n\nThis R61\u002FR33 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\u002Ffemale) and age (2-3 vs. 4-6 years). All measures will be collected at baseline and at 6-month follow-up.\n\nThe R61 feasibility phase will address three specific aims:\n\nAccrual: Achieve an enrollment rate of 10 families per month, supporting feasibility for the R33 efficacy phase.\n\nEngagement: Demonstrate that families use at least 70% of available HomeGrown intervention components, measured using the digital behavior change interventions engagement scale.\n\nData Collection \\& Retention: Achieve at least 80% retention with completion of all outcome assessments.\n\nBy 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.",[26,155],"Child Obesity",[157],"home environmental","2026-06-09",{"date":135,"type":34},{"date":161,"type":34},"2026-04-16",{"date":163,"type":22},"2027-05",{"name":165,"class":69},"UNC Lineberger Comprehensive Cancer Center",{"id":167,"slug":168,"hasResults":12,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":12,"sex":17,"minAge":173,"maxAge":174,"enrollmentInfo":175,"targetDuration":4,"studyType":53,"phases":177,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":4},"100638251","home-and-community-use-of-a-suspension-walker-in-pre-walking-infants-with-down-syndrome-100638251","NCT07631130","Home and Community Use of a Suspension Walker in Pre-Walking Infants With Down Syndrome","Feasibility of a Novel Overground Stepping Intervention for Pre-Walking Infants With Down Syndrome","Inclusion Criteria:\n\n* Diagnosis of Down syndrome\n* 10-13 months of age\n* Able to sit independently\n* Unable to walk independently\n\nExclusion Criteria:\n\n* Medical or orthopedic conditions other than Down syndrome that prevent standing or walking","10 Months","13 Months",{"count":176,"type":22},12,[81],"The goal of this clinical trial is to learn if pre-walking infants with Down syndrome can use a suspension walker in their home and community environments. The main questions it aims to answer are:\n\n* Is suspension walker intervention feasible for pre-walking infants with Down syndrome?\n* What are barriers to successfully using suspension walkers in home and community environments?\n* What are facilitators for successfully using suspension walkers in home and community environments?\n\nParticipants will:\n\n* Use a suspension walker in the home and community for a three-month period (goal 20 minutes\u002Fday, 5 days\u002Fweek)\n* Meet with a therapist three times in their home to learn how to use the walker\n* Track how often they use the walker for one week each month\n* Complete assessments of infants' gross motor skill and ability to use the walker before and after the three-month period\n* Be interviewed after the three-month period about their experiences using the walker",[26],[85,181,182,183,184,185],"infant","mobility device","walker","walking","early intervention","NOT_YET_RECRUITING","2026-06-02",{"date":189,"type":34},"2026-06-05",{"date":191,"type":22},"2026-09",{"date":193,"type":22},"2028-08",{"name":195,"class":69},"University of Southern California",{"id":197,"slug":198,"hasResults":12,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":202,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":206,"conditions":207,"keywords":210,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100640774","collaboration-for-down-syndrome-progress-cdp-100640774","NCT07625579","Collaboration for Down Syndrome Progress (CDP)","The INCLUDE (INvestigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome) Project's Collaboration for Down Syndrome Progress (CDP) Program","CDP","Inclusion Criteria:\n\n* Individual with Down syndrome\n\nTo be considered potentially eligible for this CDP, a participant must meet the following criteria:\n\n* Diagnosis of Down syndrome (with the exception of control participants for the Subsample study on Imaging). We will be enrolling participants with all types of Down syndrome including standard Trisomy 21, mosaic Down syndrome, and translocations.\n* Primary language is English, Spanish, or Portuguese.\n\nSupport Person\n\n* Able to attend in-person or remote visits.\n* Able to provide accurate information about the study participant's clinical outcomes and family history.\n* Primary language is English, Spanish, or Portuguese.\n\nBiological parent(s) biospecimen collection\n\n* Biological parent of the enrolled participant.\n* Willing to provide a biological sample.\n* Primary language is English, Spanish, or Portuguese. Imaging subsample study controls\n* A subset of controls will be enrolled to match a cohort of individuals who take part in the CDP Subsample Study on imaging. Healthy control infants must be born at greater than 36 weeks gestational age and must have at least one older sibling. The sibling criterion allows comparability for potential analyses combining control data from DS-CDP with analogous control data previously collected by IBIS for other neurodevelopmental studies.\n\nExclusion Criteria:\n\n* A participant will also be excluded if a healthcare professional determines that CDP involvement poses a risk of mental and physical harm to the participant.\n\nImaging subsample study exclusion criteria for individuals with Down syndrome and controls:\n\n* Known genetic conditions or syndromes with effects on neurobehavioral development (except for Down syndrome) such as Fragile X syndrome, Williams syndrome, or Prader-Willi syndrome. We may also exclude other syndromes such as Marfan's syndrome or Turner syndrome because of overall significant multisystem effects.\n* Birth weight \\\u003C 2,000 grams or gestational age \\\u003C 34 weeks (infants with Down syndrome infants) or \\\u003C37 weeks (control subjects)\n* Significant perinatal adversity, in utero neurotoxin exposure or maternal gestational diabetes requiring medication management\n* Significant medical conditions (unrelated to Down syndrome) affecting growth, development, cognition or sensory impairments. We will conduct a review of the medical history to identify major medical conditions that might be a reason for exclusion.\n\n  * Neurological event like a stroke\n  * Congenital infection associated with altered development (e.g., congenital rubella)\n  * Significant infection affecting the brain after birth, like meningitis\n* In infants with Down syndrome, severe medical issues which may exert significant developmental effects beyond Down syndrome such as:\n\n  * Cyanotic cardiac abnormalities (e.g., Tetralogy of Fallot) that affect overall oxygen levels\n  * Frailty because of recovery from significant surgery or extended hospital stays\n* Contraindication for MRI\n* English not predominant home language\n* Family history of a first-degree relative with psychosis or bipolar disorder (controls only)\n* To be consistent with prior imaging studies from the infant brain imaging study, healthy controls will additionally be excluded for a family history of a first- or second-degree relative with ASD to also allow them to serve as a comparison group for elevated familial liability for ASD.\n\nSleep subsample study exclusion criteria:\n\n* Participants under the age of 12 who are currently being treated for obstructive sleep apnea using a positive airway pressure (PAP) device.\n* For the WatchPAT device, participants must weigh more than 65 pounds. They cannot have a permanent pacemaker or sustained non-sinus cardiac arrhythmias.",{"count":205,"type":22},1400,"The Collaboration for Down Syndrome Progress (CDP) is a long-term study that follows people with Down syndrome of all ages. The goal is to better understand their health, development, and everyday experiences over time. Participants and their caregivers will answer questions, share medical information, and may give samples like blood or saliva. Some participants may also take part in optional activities such as sleep studies, movement tracking, or brain imaging. By collecting the same types of information at many sites, the CDP will help researchers learn why certain health conditions are more common in people with Down syndrome and how to improve care and quality of life.",[26,208,209],"Chromosome Disorders","Intellectual and Developmental Disabilities",[85],"2026-05-28",{"date":213,"type":34},"2026-06-04",{"date":215,"type":34},"2026-05-01",{"date":217,"type":22},"2029-08-31",{"name":219,"class":69},"RTI International",16,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":78,"maxAge":228,"enrollmentInfo":229,"targetDuration":4,"studyType":53,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":42},"100604961","drumming-lessons-influence-on-children-with-down-syndrome-100604961","NCT07156318","Drumming Lessons' Influence on Children With Down Syndrome","Effects of Drumming Lessons on Brain and Behavior in Children With Down Syndrome","Inclusion Criteria:\n\n* Down syndrome\n\nExclusion Criteria:\n\n* Already taken drumming lessons\n* Uncorrected hearing loss\n* Uncorrected vision loss","15 Years",{"count":52,"type":22},[81],"The goal of this clinical trial is to learn if drumming lessons can increase self-control in children with Down syndrome. The main question it aims to answer is whether 2 months of drumming lessons can improve the behavioral control and timing skills in children with Down syndrome. Participants are between 7 and 15 years of age and receive two months of drumming lessons given by a professional drummer with extensive experience working with children with Down syndrome. Children in the experimental group visit our lab once before lessons start and once after lessons are completed. Children in the control group visit our lab twice before they start their lessons. Lab visits include brain recordings taken using a net-style cap, computer tasks, and drumming to music.",[26],[234,235,236,237,238,239],"Children with Down syndrome;","Effects of drumming lessons","Effects on brain and behavior","Inhibitory control","Beat perception","Intervention study","2026-05-15",{"date":242,"type":34},"2026-05-19",{"date":244,"type":34},"2026-02-15",{"date":246,"type":22},"2027-12",{"name":248,"class":69},"Vanderbilt University",{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":4,"studyType":53,"phases":260,"briefSummary":261,"conditions":262,"keywords":263,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":42},"100638800","phase-2-modulation-of-the-immune-system-in-down-syndrome-for-improved-outcomes-and-neurodevelopment---1-100638800","NCT07598643","Modulation of the Immune System in Down Syndrome for Improved Outcomes and Neurodevelopment - 1","MISSION-1","Inclusion Criteria:\n\n1. Individuals with DS aged 6 years (inclusive) to 22 years (inclusive). All forms of DS will qualify, including complete trisomy 21, Robertsonian translocation trisomy 21, partial trisomy 21 (segmental duplication), and\u002For mosaic trisomy 21.\n2. Available parent(s) or guardian(s) legally able to sign the consent form and who can complete study materials as appropriate.\n3. Body weight is at least 10 kgs.\n\nExclusion Criteria:\n\n1. Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.\n2. Current or planned use of a JAK inhibitor during the 6-month study period.\n3. Known allergies, hypersensitivity, or intolerance to tofacitinib.\n4. Active, uncontrolled, or life-threatening infection that at the determination of the treating physician would preclude safe use of tofacitinib.\n5. History of gastrointestinal perforation.\n6. Vaccination with live attenuated virus within six weeks of inclusion in the study or planned during the study.\n\n   Note on vaccines: Participants not yet vaccinated for MMR-V should consider their timeline for MMR-V vaccination. Specifically, the study team recommends MMR-V vaccination as soon as possible and delay study start until 6 weeks after MMR-V vaccinations.\n7. Concomitant treatment with any of the following:\n\n   1. Concomitant treatment with other immunosuppressants (e.g., methotrexate, azathioprine, tacrolimus, cyclosporine).\n   2. Strong CYP3A4 inhibitors (e.g., ketoconazole).\n   3. Strong CYP3A4 Inducers (e.g., rifampin).\n   4. Moderate CYP3A4 inhibitor(s) with a strong CYP2C19 inhibitor(s) (e.g., fluconazole).\n   5. Other supplements or medications that at the determination of the treating physician would preclude safe use of tofacitinib.\n8. Evidence of severe organ dysfunction, including severe renal impairment, that at the determination of the treating physician would preclude safe administration of tofacitinib.\n9. Any history of leukemia, lymphoma, or unresolved transient myeloproliferative disorder.\n10. Any current, recurrent, or metastatic forms of cancer.\n11. Any cancer treatment within five years prior to study entry.\n12. Known personal history of thrombosis or bleeding disorder.\n13. History of tuberculosis, disseminated herpes zoster, disseminated herpes simplex, or recurrent localized herpes zoster.\n14. Intravenous antimicrobial therapy within 3 months of inclusion in the study.\n15. History of organ or bone marrow transplant.\n16. History of myocardial infarction or stroke.\n17. Evidence of lipid disorder, including but not limited to LDL \\> 190 mg\u002FdL, per discretion of the treating physician.\n18. Participant received blood or plasma products within 30 days of the Baseline visit.\n19. Treatment with intravenous immunoglobulin (IVIG) within 8 weeks of the Baseline visit.\n20. Hospitalization longer than 6 months in the last year.\n21. History of neurological syndrome that in the opinion of the study doctors would inhibit successful participation in the study.\n22. Less than 6 weeks post-surgery at Baseline appointment.\n23. Total vision or hearing loss (with no corrective devices available).\n24. Participant must be able to attempt the neurodevelopment assessment battery at Baseline and caregiver must be able to complete proxy reports for neurodevelopmental assessments.\n25. Poor venous access not allowing repeated blood tests or non-compliance with venipuncture requirements.\n26. Participants may be excluded for other unforeseen reasons at the study doctor's discretion.\n27. Pregnancy or breastfeeding.\n28. Use of estrogen-containing oral contraceptives.","6 Years","22 Years",{"count":259,"type":22},92,[55],"This protocol describes a phase 2, double-blind, randomized, placebo-controlled clinical trial for Janus kinase (JAK) inhibition in Down syndrome (DS). This trial will evaluate the safety and efficacy of a 6-month treatment with the JAK1\u002F3 inhibitor tofacitinib (XELJANZ) in individuals ages 6-22 (inclusive) with DS. There will be two main arms for this study: a treatment arm and a placebo control arm. Participants will be randomized into the treatment or placebo arm. Those completing 6 months in the placebo arm may be eligible to participate in a cross-over, open-label extension arm to receive 6 months of tofacitinib treatment. Participants will be evaluated during a Screening visit to determine eligibility, complete a Baseline visit if eligible, and be monitored via safety clinical laboratories and in-person evaluations by study doctors at 1 month, 3 months (mid-point visit) and 6 months (endpoint visit). An interim analysis of safety will be completed by an independent Data and Safety Monitoring Board (DSMB) after 40 participants have completed 6 months of treatment or placebo (20 in each arm).",[26],[85,264,265],"JAK inhibition","Tofacitinib","2026-05-13",{"date":268,"type":34},"2026-05-20",{"date":270,"type":22},"2026-05",{"date":272,"type":22},"2030-08",{"name":274,"class":69},"University of Colorado, Denver",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":283,"maxAge":50,"enrollmentInfo":284,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100375179","trial-ready-cohort-down-syndrome-trc-ds-100375179","NCT04165109","Trial-Ready Cohort-Down Syndrome (TRC-DS)","Alzheimer's Clinical Trial Consortium for Down Syndrome (ACTC-DS) Trial-Ready Cohort - Down Syndrome (TRC-DS)","TRC-DS","Inclusion Criteria:\n\n1. Diagnosis of DS (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21 or partial trisomy 21) (as confirmed by genetic testing or medical record review)\n2. Provision of signed and dated informed consent form; this includes adults with DS who can provide consent, or for whom an LAR provides consent on behalf of the individual to participate. Adults with DS who cannot consent must sign and date an assent accompanied with a signed and dated consent by legally authorized representative (LAR).\n3. Stated availability and willingness to comply with all study procedures and availability for the duration of the study or until referred to a clinical trial\n4. Male or female, aged 25-55 inclusive\n5. In good general health as evidenced by medical history with no diagnosis of dementia\n6. Permitted CNS-active medications, stable in dose for at least 4 weeks or longer. If new medications have been started, medical monitoring team will review on case by case basis to recommend timing of baseline cognitive testing\n7. Adequate visual and auditory acuity to allow neuropsychological testing\n8. Mental Age of 4 years or greater (based upon the Kaufman Brief Intelligence Test, Second Edition, KBIT-2, verbal age equivalent, or based upon medical records)\n9. Ability to complete KBIT-2 with IQ equal to or greater than 40\n10. Must speak English or Spanish fluently\n11. Must have a reliable Study Partner (may be caregiver, sibling, parent) who is capable of providing correct information about the participant's clinical symptoms and history\n\nExclusion Criteria:\n\n1. Any significant disease or unstable medical condition that could affect participation (i.e., unstable psychiatric disease, unstable cardiac problems, chronic renal failure, chronic hepatic disease, severe pulmonary disease)\n2. Participants in whom magnetic resonance imaging (MRI) is contraindicated including, but not limited to, those with a non-compatible pacemaker, presence of MRI-incompatible metallic fragments near the eyes or spinal cord, or cochlear implant (Dental fillings do not present a risk for MRI)\n3. Participants unable to complete MRI procedure\n4. History, within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment\n5. Clinically significant abnormalities in B12 or TFTs that might interfere with the study. A low B12 is exclusionary, unless follow-up labs (homocysteine (HC) and methylmalonic acid (MMA)) indicate that it is not physiologically significant. A high TSH is exclusionary unless follow up T3\u002FT4 levels indicate that it is not physiologically significant.\n6. Clinically significant abnormalities in screening laboratories\n7. For participants undergoing CSF collection: a current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening or if on anti-coagulation therapy (e.g. warfarin)\n8. Concurrent participation in a clinical trial for an investigational product or concurrent participation in longitudinal study with overlapping outcome measures\u002Fprocedures is prohibited with the exception of ABC-DS co-enrollment or as approved by project director\n9. Participants whom the investigator deems to be otherwise ineligible. The Investigators should consult with the Coordinating Center on any issues that may disqualify the participant from participation in future clinical trials to determine whether enrollment into TRC-DS would be appropriate","25 Years",{"count":285,"type":22},550,"The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 550 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression.\n\nTo learn more about the study and participating sites, visit our study website at: https:\u002F\u002Fwww.trcds.org\u002F.\n\nTRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as \"co-enrollment\". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https:\u002F\u002Fwww.nia.nih.gov\u002Fresearch\u002Fabc-ds or http:\u002F\u002Fabcds.pitt.edu\u002F.",[26,59,288],"Dementia",[290,291,292,293,26],"Trial-Ready Cohort","Observational","Alzheimer's","Prevention",{"date":295,"type":34},"2026-05-18",{"date":297,"type":34},"2021-06-07",{"date":299,"type":22},"2027-12-31",{"name":195,"class":69},22,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":17,"minAge":309,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":53,"phases":313,"briefSummary":314,"conditions":315,"keywords":316,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":42},"100638633","effects-of-bean-bag-tossing-game-on-balance-and-gait-in-children-with-down-syndrome-100638633","NCT07578922","Effects of Bean Bag Tossing Game on Balance and Gait in Children With Down Syndrome.","Effects of Bean Bag Tossing Game Using Static and Dynamic Surface on Balance and Gait in Children With Down Syndrome","Inclusion Criteria:\n\n* Ageof7-12years\n* Abletorecognize the command given to them\n* Understand the verbal command\n* Standand walk independently without repeated falling\n* Normalvisualization and Audible range\n\nExclusion Criteria:\n\n* Children suffering from seizures\n* Children with Multiple Sclerosis\n* Children with Muscular Dystrophy\n* Children with cardiac anomalies","5 Years","17 Years",{"count":312,"type":22},36,[81],"The research design will be a randomized clinical trial. The study will recruit 36 children with spastic cerebral palsy and toe walking that fall within the ages of 5-17 years who have a defined balance deficit. The participants will be randomly assigned to one of two groups: group A (n=18), which will play the Bean Bag Tossing Game on Wedge, and group B (n=18), which will play the Bean Bag Tossing Game on a Balance Board. The intervention will be performed 3 times a week for 4 weeks 30 minutes a day. All participants will be assessed according to eligibility criteria. Guardians of participants who meet the eligibility criteria are requested to sign consent forms before they are entered into the study. The study involves two standardized assessment tools that measure the Gait and balance in children with Down syndrome: Berg Balance Scale and GALLOP Scale. The synopsis will present to the Research Ethical Committee of Riphah International University Lahore for ethical approval to conduct this study. Data will be analyzed by SPSS 27.0 version",[26],[317],"Down syndrome, Balance, Gait, Bean Bag Tossing","2026-05-05",{"date":320,"type":34},"2026-05-11",{"date":322,"type":34},"2025-10-28",{"date":324,"type":22},"2026-06-15",{"name":326,"class":69},"Riphah International University",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":228,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":53,"phases":336,"briefSummary":338,"conditions":339,"keywords":341,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":346,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":42},"100633842","phase-1-escalating-doses-of-memantine-in-down-syndrome-meds-123-100633842","NCT07531940","Escalating Doses of Memantine in Down Syndrome (MEDS-123)","Phase 1B Trial on Escalating Doses of Memantine in Down Syndrome","Inclusion Criteria:\n\n* Cytogenetically documented Trisomy 21 or Complete Unbalanced Translocation of Chromosome 21. Mosaic Trisomy 21 and partial translocations will be excluded from the study\n* No pregnancy by serum testing at screening. Females of child-bearing potential, sexually active must be practicing a reliable method of birth control. Urine pregnancy tests will be done at the 2 follow-up medical visits\n* Laboratory findings within normal limits or judged clinically insignificant at baseline\n* Vital signs within normal limits for age. Stable, medically treated hypotension will be allowed\n* ECG must demonstrate predominately normal sinus rhythm. Minor abnormalities documented as clinically insignificant will be allowed\n* Participants and their authorized representatives will provide written informed consent\n* Participants who have received any experimental drug for Down syndrome must undergo a washout\n* All participants must: Be in general good health as judged by the investigators; Be able to swallow oral medication; Have a reliable caregiver or family member who agrees to accompany participant to all visits, provide information about the participant as required by the protocol, and ensure compliance with the medication schedule; Be sufficiently proficient in English to reliably complete the study assessments\n* Age and gender matching participants without Down syndrome, must be: Males or females without Down syndrome aged-matching (within 3 years) participants with Down syndrome whom they are expected to serve as controls\n\nExclusion Criteria:\n\n* Participant weighing less than 40 kg\n* Current psychiatric or neurologic diagnosis other than Down syndrome (e.g., major depressive disorder, schizophrenia, bipolar disorder, autism, Alzheimer disease)\n* Current treatment with psychotropic drugs\n* Drug or alcohol abuse or dependence\n* Significant suicide risk or who would require treatment with electro-convulsive therapy or with psychotropic drugs during the study or who have received treatment with a depot neuroleptic drug within 6 months of entering the study.\n* Current or expected (within the next 6 months) hospitalization or residence in a skilled nursing facility (may reside in group homes or other residential settings with no skilled nursing)\n* Active or clinically significant conditions affecting absorption, distribution, or metabolism of study drug (e.g. inflammatory bowel disease or celiac disease)\n* Significant allergies to or other significant intolerance of memantine therapy, its ingredients, or with contraindications to memantine therapy as stated in the prescribing information\n* Participants who are expected to require general anesthetics during the course of the study\n* Presence or recent history of seizure disorder (\\\u003C 3 years).\n* Clinically significant and\u002For clinically unstable systemic disease. (Those with controlled hypothyroidism must be on a stable dose of medication for at least 3 months prior to screening and have normal serum T-4 and TSH at screening; and those with controlled diabetes mellitus must have an HbA1c of \\\u003C 8.0% and a random serum glucose value of \\\u003C 170 mg\u002Fdl)\n* Severe infections or a major surgical operation within 3 months prior to screening\n* History of persistent cognitive deficits immediately following head trauma.\n* Donation of blood or blood products less that 30 days prior to screening, while participating in the study, or four weeks after completion of the study\n* Inability to comply with the protocol or perform the outcomes measures due to significant hearing or visual impairment or other issues judged relevant by the investigators","32 Years",{"count":7,"type":22},[337],"PHASE1","Down syndrome (DS) is typically caused by an extra chromosome 21 in the cell nucleus (trisomy 21, or T21). T21 is both the most common cause of genetically defined intellectual disability and the earliest documented cause of Alzheimer's disease (AD)-type pathology. Currently, all presymptomatic individuals with DS are classified as having 'Stage 0' DS-associated AD (DSAD). DSAD pathology evolves inexorably, with virtually all individuals with DS developing AD pathology by age 40, and approximately 50% meeting clinical dementia diagnosis criteria at 55 years of age. This study will test the hypothesis that the FDA-approved AD drug memantine, at higher-than-standard doses, may be effective as a cognitive enhancer in adolescents and young adults with DS. The primary goal of this phase 1b clinical trial will be the assessment of the safety and tolerability of three memantine doses in persons with DS. In addition, we will assess the effect of this drug on cognitive test scores and plasma biomarkers of AD in the study participants. Finally, we will also investigate steady-state plasma levels of memantine and the time course of memantine plasma levels after a single dose in the study participants (pharmacokinetics, or PK). The data generated through this phase 1b study will provide the essential safety, PK, and preliminary efficacy signals required to advance a phase 2 trial evaluating high-dose memantine as a first-in-class therapeutic strategy in DS.",[26,340],"Intellectual Disability",[342,343,344,345],"Memantine","Episodic Memory","CVLT","Short-term memory",{"date":320,"type":34},{"date":348,"type":22},"2026-06",{"date":350,"type":22},"2028-05",{"name":352,"class":69},"University Hospitals Cleveland Medical Center",{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":256,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":367,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":375},"100493245","a-study-to-learn-more-about-the-health-of-persons-with-down-syndrome-after-treatment-for-acute-leukemia-100493245","NCT05702645","A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia","Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)","Inclusion Criteria:\n\n* Patients age \\>= 6 and \\\u003C 40 years at the time of enrollment\n* A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells)\n* All patients must be DS-AL survivors (acute lymphoblastic leukemia \\[ALL\\] or acute myeloid leukemia \\[AML\\])\n\n  * Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant\n  * Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study\n* Patients must have been treated for ALL or AML\n\n  * Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above\n* All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment\n* Patients must have a life expectancy of \\> 1 year\n* Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish\n\n  * Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are \\>= 18 years old\n* All patients and\u002For their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met\n\nExclusion Criteria:\n\n* Patients with history of hematopoietic stem cell transplant (HSCT) are excluded\n\n  * Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied\n* Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded\n\n  * Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility\n* Patients whose parents or guardians are unable to complete the required forms are excluded","39 Years",{"count":362,"type":22},330,"This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.",[365,26,366],"B Acute Lymphoblastic Leukemia Associated With Down Syndrome","Myeloid Leukemia Associated With Down Syndrome",{"date":318,"type":34},{"date":369,"type":34},"2023-11-30",{"date":371,"type":22},"2029-06-30",{"name":373,"class":374},"Children's Oncology Group","NETWORK",70,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":53,"phases":387,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":42},"100611275","phase-3-exploring-sympathetic-nervous-system-function-in-individuals-with-down-syndrome-100611275","NCT07238465","Exploring Sympathetic Nervous System Function in Individuals With Down Syndrome","Dysautonomia InVestigation in Individuals With Down SyndromE: DIVE Study","DIVE","Inclusion Criteria:\n\n* 18-50 yrs old and apparently healthy individuals\n* Ability to understand the study and give assent to participate\n* Has a study partner who can attend all visits for the individuals with DS, and answer questionnaires, provide consent when necessary\n* Corrected or non-existent congenital heart disease\n* Euthyroid or on stable thyroid medication dose for at least 6 months\n* Free from cardiovascular, pulmonary, inflammatory, or metabolic disease in the past 6 months that would prevent participation in study procedures\n* BMI \\\u003C45kg\u002Fm2\n* Ability to tolerate repeated blood draws \u002F catheter placement\n\nExclusion Criteria:\n\n* Hypertension (resting systolic blood pressure \\[SBP\\] ≥140 and\u002For diastolic blood pressure \\[DBP\\] ≥90 mmHg) this includes those on medications to treat hypertension\n* Hypotension (resting BP of \\\u003C90\u002F60 mmHg)\n* Cancer in the last six months\n* Any heart-rate-altering medications or any other medication that may modify metabolic responses\n* Self-reported diabetes or use of glucose-lowering medication\n* Tobacco products, including vaping, or marijuana use\n* Currently pregnant\n* Post-menopausal women\n\nSpecific Exclusion Criteria for Certain Stressors:\n\n* Orthopedic limitations that would prohibit exercise or movement for exercise\n* Fracture of limb to be immersed for CPT\n* Open cut or sore on hand to be immersed for CPT\n* Raynaud's syndrome for CPT\n* Chronic caffeine drinkers for caffeine stressor (consumption of caffeine in the last 7 days)","50 Years",{"count":386,"type":22},200,[388],"PHASE3","Down syndrome (DS), the most common genetic cause of intellectual disability, is associated with widespread organ dysfunction, including abnormalities in the autonomic nervous system (ANS). The ANS regulates critical functions such as heart rate (HR) and blood pressure (BP), both essential for maintaining homeostasis and supporting physical activity. Individuals with DS often exhibit blunted HR responses to exercise-typically \\~30 beats per minute below expected levels-suggesting reduced sympathetic nervous system (SNS) activity. The SNS governs rapid changes in HR and BP during stress by releasing catecholamines: epinephrine (from the adrenal medulla) and norepinephrine (from sympathetic nerve endings). Despite its importance, SNS function has not been comprehensively assessed among individuals with DS.\n\nThis study addresses a critical knowledge gap by evaluating SNS responses to physiological stressors in individuals with DS. The investigators will measure beat-to-beat HR and BP, along with plasma catecholamine levels, in response to sympathetic activation, comparing individuals with DS to age- and sex-matched controls. Understanding the mechanisms of SNS dysfunction in DS is vital, as it likely underlies reduced exercise capacity and contributes to broader clinical challenges. These insights may guide targeted interventions to improve cardiovascular function, physical capacity, and overall quality of life in this understudied population.",[26,391],"Autonomic Dysfunction",[393,394,395,396,397,398,399,400,401,402,403,404],"Cold Stress","Pain Responses","Fear","Exercise","Blood Pressure","Heart Rate","Caffeine","12-Hour Fast","Catecholamines","Epinephrine","Norepinephrine","Dopamine","2026-04-28",{"date":407,"type":34},"2026-05-04",{"date":409,"type":34},"2026-04-06",{"date":411,"type":22},"2029-12",{"name":274,"class":69},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":42},"100532460","patterns-of-neurodevelopmental-disorders-100532460","NCT06213090","Patterns of Neurodevelopmental Disorders","Patterns of Disease, Outcomes and Treatment Response in Children With Neurodevelopmental Disorders","Inclusion Criteria:\n\nNeurodevelopmental delays Clinical visit at an Rossignol Medical Center\n\nExclusion Criteria:\n\n\\-",{"count":421,"type":22},1000,"The purpose of this study is to systematically evaluate the results of medical investigations to identify symptom and biological patterns and common etiologies of neurodevelopmental disorders.",[424,425,426,427,26,428,429,430],"Neurodevelopmental Disorders","Autism Spectrum Disorder","Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcal Infection","Pediatric Acute-Onset Neuropsychiatric Syndrome","Epilepsy","Mitochondrial Encephalomyopathies","Cerebral Folate Deficiency","2026-04-13",{"date":161,"type":34},{"date":434,"type":34},"2024-02-01",{"date":436,"type":22},"2030-12-31",{"name":438,"class":69},"Richard Frye",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":256,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":53,"phases":447,"briefSummary":449,"conditions":450,"keywords":452,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":468},"100614505","phase-4-endotype-directed-treatment-for-osa-in-down-syndrome-100614505","NCT07280468","Endotype DIrected Treatment for OSA in Down Syndrome","EDIT OSA","Inclusion Criteria:\n\n1. Age 6 years or older\n2. Down syndrome diagnosis\n3. Any gender or ethnicity\n4. Adults without a legally authorized representative must have a caregiver\u002Fsupport person that can co-sign consent and complete study questionnaires.\n\nExclusion Criteria:\n\n1. Currently using and adherent to PAP therapy (\\>4 hours per night for 70% of nights in the past 30 days based on device download or parent\u002Fcaregiver report)\n2. MAO inhibitor use\n3. Urinary retention\n4. Seizure disorder\n5. Untreated or inadequately treated hypothyroidism\n6. Significant traumatic brain injury\n7. Not cleared to participate in the study by their cardiologist for individuals with congenital heart disease requiring follow up with cardiology at least once in the past year\n8. History of current, untreated depression\n9. History of liver disease (not including metabolic dysfunction-associated steatotic liver disease)\n10. 3+ or greater tonsillar hypertrophy (for children only, no restriction for adults)",{"count":386,"type":22},[448],"PHASE4","Down syndrome is the most common genetic cause of intellectual disability. People with Down syndrome often have obstructive sleep apnea (OSA), a condition where people have difficulties with breathing while asleep. OSA can lead to poor sleep, worse quality of life, behavior problems and more difficulties with thinking (\"cognitive impairment\"). Current treatments for OSA in people with Down syndrome are not very effective or require surgery. The combination of 2 medications, atomoxetine and oxybutynin (\"ato-oxy\") is a promising treatment for OSA in people with Down syndrome, but ato-oxy does not work for everyone with Down syndrome. Similarly, oxygen is effective for OSA in some people, but does not work for everyone. This study will evaluate the use a precision medicine approach to increase the effectiveness of OSA treatment in people with Down syndrome. The study will compare two groups. In the first group, everyone will be treated with ato-oxy. In the second group, a precision medicine approach will be used to assign participants to either ato-oxy or oxygen therapy, based on the specific reasons they have OSA.\n\nThe research team will enroll 200 children (age 6-17 years old) and adults with Down syndrome and OSA from five sites across the country. Half of participants will randomly receive ato-oxy while the other will receive either oxygen or ato-oxy dependent upon which treatment would be expected to work better for them. The research team will measure OSA severity, quality of life, behavior and cognition at the start of the study and after 12 months of treatment for every participant. The study will also track any treatment side effects for each treatment group.",[451,26],"Obstructive Sleep Apnea (OSA)",[85,453,454,455,456,457,458],"obstructive sleep apnea","ato-oxy","precision medicine","oxygen","atomoxetine","oxybutynin","2026-04-01",{"date":461,"type":34},"2026-04-07",{"date":463,"type":34},"2026-03-14",{"date":465,"type":22},"2030-01",{"name":467,"class":69},"University of Arizona",5,{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":475,"eligibilityCriteria":476,"healthyVolunteers":16,"sex":17,"minAge":477,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":515},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","0 Years","20 Years",{"count":480,"type":22},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[483,484,485,486,487,488,489,490,491,492,493,494,495,496,497,498,499,500,501,502,503,504,505,506,26],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","2026-03-31",{"date":409,"type":34},{"date":510,"type":34},"2020-03-05",{"date":512,"type":22},"2027-07",{"name":514,"class":69},"Duke University",51,{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":16,"sex":17,"minAge":283,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":53,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":42},"100454395","gamma-frequency-stimulation-in-individuals-with-down-syndrome-100454395","NCT05196984","Gamma Frequency Stimulation in Individuals With Down Syndrome","Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation","Inclusion Criteria:\n\n* Subject is between the ages of 25-65\n* Subject must have a clinically confirmed diagnosis of Down Syndrome (karyotypes optional). Individuals with mosaic Down syndrome will be excluded.\n* Subject or their legal guardian is willing to sign informed consent document.\n* If subject is deemed to not have capacity to sign the informed consent, he\u002Fshe will need a legally authorized representative to provide surrogate consent.\n* Subject will be medically stable with consistent medication over the previous 3 months.\n\nExclusion Criteria:\n\n* Subjects has history of a dual diagnosis Down Syndrome and Autism\n* Subjects with has history of seizure or epilepsy within the past 24 months.\n* Subjects with a new diagnosis of Attention-deficit\u002Fhyperactivity disorder (ADHD) (\\\u003C 6 months) or untreated ADHD\n* Active treatment with one or more anti-epileptic agent.\n* Subjects who have a known history a stroke within the past 24 months.\n* Subjects with a known history of migraine headache.\n* Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.\n* Subjects with clinically significant suicide risk and\u002For suicide attempt in the past 1 year.\n* Subjects with behavioral problems such as aggression\u002Fagitation\u002Fimpulsivity that might interfere with their ability to comply with protocol.\n* Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).\n* Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and\u002For sacral nerve stimulator.\n* Subjects who have profound and uncorrected hearing or visual impairment.\n* Subjects who are pregnant (self-report).","65 Years",{"count":525,"type":22},60,[81],"Down Syndrome (DS) is characterized by an additional copy of chromosome 21, which also increases risk of Alzheimer's Disease (AD). The investigators' lab found a non-invasive way to remove toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators then translated this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients and cognitively normal adults. The investigators have also translated this research into a vibrating speaker device to study tactile vibration to stimulate the brain as well. For the present study, 30 participants with Down Syndrome and 30 cognitively normal adult controls will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) during light, sound, and tactile stimulation. The investigators will also test for safety, feasibility, and cognitive performance before and after a 30-60 minute session of light and sound stimulation to optimize the stimulation devices for use in the DS population.",[26],[26,59,530,531,532,533],"Non-Invasive Sensory Stimulation","Light and Sound Stimulation","Gamma","Tactile Stimulation","2026-03-30",{"date":507,"type":34},{"date":537,"type":34},"2021-12-06",{"date":539,"type":22},"2026-12-31",{"name":541,"class":69},"Massachusetts Institute of Technology",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":550,"maxAge":105,"enrollmentInfo":551,"targetDuration":4,"studyType":53,"phases":553,"briefSummary":554,"conditions":555,"keywords":557,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":566,"locationsCount":42},"100576317","sleep-intervention-and-quality-of-life-in-down-syndrome-100576317","NCT06783725","Sleep Intervention and Quality of Life in Down Syndrome","Improving Sleep and Quality of Life in Individuals With Down Syndrome and Their Caregivers","SleepDS","Inclusion Criteria:\n\n* Individuals with a confirmed diagnosis of Down syndrome (DS).\n* English is the primary language spoken in the household.\n* Nonverbal mental age of at least 36 months, as determined by a baseline measure of adaptive skills.\n* Presence of at least one sleep disturbance occurring five or more nights per week, as reported by a caregiver. Sleep disturbances may include: Bedtime resistance; Delayed sleep onset; Problematic sleep associations; Nighttime awakenings; Early morning awakenings\n\nExclusion Criteria:\n\n* Severe sensory or motor impairments that would interfere with participation in the intervention.\n* Inability to complete assessments or participate in the intervention sessions due to behavioral or medical conditions.\n* Participation in other concurrent behavioral or sleep interventions.\n* Caregiver inability or unwillingness to provide accurate reports or assist in intervention activities as needed.","12 Months",{"count":552,"type":22},20,[81],"Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS and sleep medicine to ensure that the intervention protocol is relevant and appropriate for young people with DS (age 12 and older). Planned adaptations include 1) utilization of visual aids and videos to increase engagement and reinforce mindfulness concepts and practices; 2) shortened meditation practices to accommodate concentration limits of individuals with DS; 3) caregiver involvement reflecting the important role of caregivers in daily functioning of individuals with DS; 4) adapted homework to cater to the learning styles of individuals with DS; 5) daily reminders to encourage regular practice and reinforce the importance of consistency; and 6) modified session structure to ensure that participants are able to discuss their experiences and refine their mindfulness practice. During the first 6 months of the project, the investigators will meet monthly with the community advisory board and use an iterative process to develop detailed intervention protocol for a virtual MBTI suitable for young people with DS.\n\nAim 2 of the project will be to pilot test the efficacy of the virtual MBTI for young people with DS. In the second half of the one-year project, the investigators will conduct a pilot randomized clinical trial (RCT) of the intervention developed in Aim 1.\n\nThis project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people with Down syndrome (DS). The interventions will be compared on their impact on improving sleep problems, quality of life, and functional outcomes. This project will also test if targeting the sleep of the caregiver in addition to the individual with Down syndrome has any effect on the outcomes.",[26,556],"Down Syndrome (Trisomy 21)",[85,558,559],"sleep","Mindfulness-Based Therapy for Insomnia","2026-03-18",{"date":562,"type":34},"2026-03-20",{"date":564,"type":34},"2025-03-01",{"date":299,"type":22},{"name":567,"class":69},"University of Alabama at Birmingham",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":4,"eligibilityCriteria":574,"healthyVolunteers":12,"sex":17,"minAge":575,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":53,"phases":578,"briefSummary":579,"conditions":580,"keywords":581,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":592,"locationsCount":42},"100630191","effects-of-the-otago-exercise-program-on-balance-endurance-and-motor-coordination-in-children-with-down-syndrome-100630191","NCT07484464","Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome","Effects of OTAGO Exercise Program On Balance, Endurance And Motor Coordination In Children With Down Syndrome","Inclusion Criteria:\n\n* • Clinically diagnosed with Trisomy 21.\n\n  * Aged between 8-14 years.(29)\n  * Able to follow basic verbal instructions.\n  * Ambulatory with or without assistive devices\n\nExclusion Criteria:\n\n* • Severe visual or auditory impairments.\n\n  * Patient with moderate to severe cognitive impairments. (29)\n  * Co-morbid neurological conditions (e.g., uncontrolled seizures, cerebral palsy).\n  * Cardiac contraindications to moderate physical activity","8 Years","14 Years",{"count":52,"type":22},[81],"The study will use a quasi-experimental design conducted over ten months in pediatric physiotherapy departments of tertiary care hospitals and special education schools. It will include 30 children aged 6-14 years with mild to moderate intellectual disability, selected after eligibility screening and guardian consent. Outcomes will be assessed using BOT-2, Berg Balance Scale, MMSE-C, and Six-Minute Walk Test to measure motor skills, balance, cognition, and endurance. Ethical approval will be obtained from the Research Ethical Committee of Riphah International University, Lahore, and data will be analyzed using SPSS version 26.0.",[26],[582,583,584,585],"Balance,","Motor Coordination","Endurance","OTAGO Exercises","2026-03-16",{"date":562,"type":34},{"date":589,"type":34},"2026-03-02",{"date":591,"type":22},"2026-08-30",{"name":326,"class":69},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":17,"minAge":599,"maxAge":600,"enrollmentInfo":601,"targetDuration":4,"studyType":53,"phases":603,"briefSummary":604,"conditions":605,"keywords":611,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":42},"100479797","self-supporting-nasopharyngeal-airway-ssnpa-treating-upper-airway-obstruction-in-hypotonia-100479797","NCT05527652","Self-Supporting Nasopharyngeal Airway (ssNPA) Treating Upper Airway Obstruction in Hypotonia","Inclusion Criteria:\n\n* Children with Hypotonic Upper Airway Obstruction (HUAO): This includes those who newly diagnosed with obstructive sleep apnea (OSA). These children will undergo overnight polysomnography to determine the presence of OSA (apnea-hypopnea index \\[AHI\\]\\>10 or AHI\\>5 with nocturnal hypoxemia defined as oxygen saturation by pulse oximetry \\[SpO2\\] nadir \\\u003C=75%).\n* All subjects require the presence of at least one symptom of OSA (such as snoring 3 or more nights per week, daytime sleepiness, or hyperactive\u002Finattentive behaviors)\n* Post adenotonsillectomy or those with contraindications to tonsillectomy.\n* Tonsil size 2+ or smaller.\n* Parent\u002Fcaregivers willing and able to provide informed consent and child willing and able to provide assent, where appropriate.\n\nExclusion Criteria:\n\n* AHI ≤10 on polysomnogram (PSG) without hypoxemia or AHI\\\u003C5 with hypoxemia.\n* Any medical reason why Self-Supporting Nasopharyngeal Airway (ssNPA) therapy may not be suitable\n* Active Coronavirus (COVID) 19 infections\n* End-tidal carbon dioxide (ETCO2) or Transcutaneous carbon dioxide (TCO2) values \\>60 mmHg for \\>10% of sleep time on PSG\n* Psychiatric, medical, or social factors likely to invalidate assessments, make adherence with ssNPA highly unlikely or make local follow-up at 8 weeks unfeasible. Some psychiatric conditions may be provoked or exacerbated by OSA, and those most commonly implicated - Attention Deficit\u002FHyperactivity Disorder, Conduct Disorder, and Oppositional Defiant Disorder - will not be exclusions. However, more pervasive conditions such as severe autism will be excluded.\n* Presence of supraglottic airway collapse or more distal airway stenosis or collapse (for example glottic, subglottic stenosis, or concern for distal airway stenosis or malacia)\n* Moderate\u002Fsevere tracheobronchomalacia\n* Need for anticoagulative therapy\n* Bleeding disorder\n* Restrictive thoracic disorders","3 Years","21 Years",{"count":602,"type":22},40,[81],"The researchers are investigating if the Self-Supporting Nasopharyngeal Airway (ssNPA) device can be used in the treatment of obstructive sleep apnea in children with Hypotonic Upper Airway Obstruction (HUAO).",[606,607,608,609,610,26],"Obstructive Sleep Apnea","Hypertonia, Muscle","Nasal Airway Obstruction","Tolerance","Trisomy 21",[612,613,607,614,615,616,617,618,619,620,621,622],"Sleep Apnea Syndromes","Sleep Apnea, Obstructive","Apnea","Respiration Disorders","Respiratory Tract Diseases","Sleep Disorders, Intrinsic","Dyssomnias","Sleep Wake Disorders","Nervous System Diseases","Neuromuscular Manifestations","Neurologic Manifestations","2026-03-10",{"date":625,"type":34},"2026-03-12",{"date":627,"type":34},"2022-11-16",{"date":629,"type":22},"2026-12",{"name":631,"class":69},"University of Michigan",{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":640,"enrollmentInfo":641,"targetDuration":4,"studyType":53,"phases":643,"briefSummary":644,"conditions":645,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":652,"leadSponsor":653,"locationsCount":42},"100514975","brain-outcomes-with-lifestyle-change-in-down-syndrome-100514975","NCT05985486","Brain Outcomes With Lifestyle Change in Down Syndrome","The Impact of Weight Loss on Alzheimer's Disease Risk in Adults With Down Syndrome","BOLD","Inclusion Criteria:\n\n* Diagnosis of Down syndrome\n* BMI of 25 to 50 kg\u002Fm2\n* Ability to communicate through spoken language.\n* Ability to come to the University of Kansas Medical Center 3 times across 1 year for outcomes testing\n* Living at home with a parent\u002Fguardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner including providing transportation to our facilities for study assessments.\n\nExclusion Criteria:\n\n* Diagnosis of dementia\n* Insulin dependent diabetes\n* Participation in a weight management program involving diet or physical activity in the past 6 mos.\n* Dairy allergy\n* Serious medical risk (e.g., cancer, recent heart attack, stroke, pregnancy, angioplasty)\n* Unwilling to be randomized\n* Contraindications for MRI, including metal implants or devices incompatible with MRI such as pacemakers, claustrophobia, and inability to lay in a supine position\n* Use of GLP-1 medications\n* Use of anti-amyloid medications","64 Years",{"count":642,"type":22},81,[81],"The goal of this study is to determine if weight loss or changes in dietary intake can help prevent of delay adults with Down syndrome from developing Alzheimer's Disease\n\nAdults with Down syndrome without dementia will be randomized to either a weight loss group or a general health education control group. The weight loss group will be asked to follow a reduced energy diet, attend monthly education sessions delivered remotely and self-monitor diet and body weight using commercially available web-based applications. The control group will be asked to attend remotely delivered monthly education sessions on general health education topics.\n\nAll participants will come to the University of Kansas Medical Center, 3 times across 12 months for a blood draw, cognitive testing, a MRI, assessment of height and weight, and assessment of diet intake.",[26,59,646],"Obesity","2026-03-09",{"date":649,"type":34},"2026-03-11",{"date":651,"type":34},"2024-10-22",{"date":140,"type":22},{"name":654,"class":69},"University of Kansas Medical Center",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":12,"sex":17,"minAge":662,"maxAge":228,"enrollmentInfo":663,"targetDuration":4,"studyType":53,"phases":665,"briefSummary":666,"conditions":667,"keywords":668,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":678,"leadSponsor":679,"locationsCount":42},"100625917","effects-of-jump-rope-on-navicular-drop-in-down-syndrome-100625917","NCT07428863","Effects of Jump Rope on Navicular Drop in Down Syndrome","Effects of Jupming Rope on Navicular Drop and Foot Posture in Children With Down Syndrome","Inclusion Criteria:\n\n* age of 4 to 15 years\n* navicular drop\n* prone foot\n* Acute musculoskeletal injuries\n* Normal: 5-10 mm\n* Excessive Drop: \\>10 mm (indicating possible flatfoot)\n* Minimal Drop: \\\u003C5 mm (indicating a higher arch)\n\nExclusion Criteria:\n\n* visual or auditory impairment\n* lower limb trauma\n* recent Surgical Intervention on lower limb\n* Non- compliance and behavioral issue\n* Inability to participate","4 Years",{"count":664,"type":22},32,[81],"foot posture in children with Down syndrome. The current study will be randomized control trial, data will be collected from Tanzeem ul Lissan School FSD, Children Hospital FSD and Allied Hospital FSD. The study will include 32 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will be Children between the age of 4 to 15 years with navicular drop and prone foot. Patients with visual or auditory impairment, lower limb trauma, recent Surgical Intervention on lower limb will be excluded from the study. Experimental group will perform jumping rope combined with play activities and control group will be given play activities. Data collection will be done before and after the intervention. Tools used for data collection will be Navicular Drop Test and Foot Posture Index .Data will be analyzed through SPSS version 23.00.",[26],[26,669,670,671,672,673],"foot muscle deformities","navicular drop","play activities","jumping rope","foot posture","2026-02-23",{"date":676,"type":34},"2026-02-24",{"date":322,"type":34},{"date":674,"type":22},{"name":326,"class":69},{"id":681,"slug":682,"hasResults":12,"nctId":683,"briefTitle":684,"officialTitle":685,"acronym":686,"eligibilityCriteria":687,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":53,"phases":690,"briefSummary":691,"conditions":692,"keywords":702,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":708,"lastUpdatePostDateStruct":709,"startDateStruct":710,"completionDateStruct":712,"leadSponsor":714,"locationsCount":716},"100572968","physical-activity-and-community-empowerment-project-100572968","NCT06740162","Physical Activity and Community EmPOWERment Project","A Stage 1 Pilot Test for Feasibility and Efficacy of a Multi-Level Intervention to Increase Physical Activity in Adults With Intellectual Disability: Physical Activity and Community EmPOWERment (PACE)","PACE","Inclusion criteria for adults with ID will include:\n\n* ages 18 and older with a prior clinical diagnosis of ID, confirmed by scores \\\u003C 70 and + 90% on the Leiter-3 International Performance Scales and\u002For an adaptive behavior measure using the Vineland Adaptive Behavior Scales,\n* Medical clearance to participate in moderate-to-vigorous physical activity as determined by the American College of Sports Medicine (ACSM) preparticipation algorithm,\n* Adult does not show clinically elevated symptoms of Alzheimer's Disease (AD)\u002F Alzheimer's Disease and Related Dementias (ADRD) as indicated by a score of \\\u003C 20 on the Dementia Screening Questionnaire for Individuals with Intellectual Disabilities.\n* One caregiver\u002Fguardian is able and willing to participate.\n* must tolerate at least 8 hours of daily wear-time of Actigraph device during initial assessment period (4 of 7 days),\n* must average 20 minutes or less of moderate to vigorous physical activity (MVPA) minutes per day (140 MVPA minutes or less across 7-day period measured during the initial assessment period, and\n* must reside in North Carolina or Arkansas.\n\nExclusion Criteria for adults with ID:\n\n• Diagnosis of AD, dementia, or related disorders. Participants will not be excluded based on gender, race, or ethnicity. There will be no upper age limit due to the heterogeneity of onset of AD\u002FADRD in individuals with ID.\n\nInclusion criteria for coach will include:\n\n* access to the internet and a mobile device,\n* has weekly contact with the adult participant with ID,\n* can converse and read in English to comprehend intervention materials and website content, and\n* must reside in North Carolina or Arkansas\n\nInclusion criteria for caregiver will include:\n\n* ability to converse and read in English to comprehend and answer interview questions, (2) must care for an adult with ID who is willing to participate in the study,\n* must reside in North Carolina or Arkansas, and\n* must attend all study visits with adult with ID.",{"count":689,"type":22},376,[81],"Purpose: Conduct a wait-list randomized controlled trial (RCT) of an inclusive physical activity program called PACE for adults with intellectual disability (ID) who are not yet showing signs of Alzheimer's Disease (AD)\u002Fage-related dementias (ARD).\n\nParticipants: Participants include 120 adults with ID, their caregivers, and their coaches (up to 360 individual participants, grouped as triads), recruited through the University of North Carolina at Chapel Hill and the University of Arkansas. Participants also include 16 exercise professionals.\n\nProcedures (methods): Each cohort will include 20 triads who are randomly assigned to the PACE program or the waitlist control group.",[340,424,425,26,693,694,695,696,697,698,699,700,701],"Fragile X Syndrome","Cri-du-Chat Syndrome","De Lange Syndrome","Mental Retardation, X-Linked","Prader-Willi Syndrome","Rubinstein-Taybi Syndrome","Trisomy 13 Syndrome","WAGR Syndrome","Williams Syndrome",[703,704,705,706,707],"physical activity","intellectual disability","age-associated memory impairment","aging","Alzheimer Disease prevention","2026-02-19",{"date":674,"type":34},{"date":711,"type":34},"2025-01-10",{"date":713,"type":22},"2028-06",{"name":715,"class":69},"University of North Carolina, Chapel Hill",2]