[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"down-syndrome-ds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:down-syndrome-ds":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,44,72,97,128,153,198,226,255,287,318],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100614353","phase-1-nad-augmentation-to-prevent-or-reverse-alzheimers-disease-in-people-with-down-syndrome-100614353",false,"NCT07278492","NAD Augmentation to Prevent or Reverse Alzheimer's Disease in People With Down Syndrome","Nicotinamide Adenine Dinucleotide Augmentation to Prevent or Reverse the Progression of Alzheimer's Disease in People With Down Syndrome","Inclusion Criteria:\n\n1. A diagnosis of full trisomy for chromosome 21 or complete unbalanced translocation of chromosome 21, confirmed by karyotype analysis or clinical documentation.\n2. 18 years or older\n3. Participant has a caregiver\u002F informant who has direct contact with the participant \\>10 hours\u002F week and who can provide information about participant's health\n4. Participant or Legal Authorized Representative is able to understand and willing to provide written informed consent and capable of completing study assessments.\n5. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.\n\nExclusion Criteria\n\n1. Fasting morning UACR \\> 5,000 mg\u002F g creatinine\n2. Other laboratory abnormalities:\n\n   1. Has AST or ALT \\> 3 times the upper limit of normal\n   2. eGFR \\\u003C 30 mL\u002F min \u002F 1.73 m2\n   3. Hematocrit \\\u003C 0.34 or \\> 0.50 L\u002FL\n3. A major adverse cardiovascular event in preceding 3 months\n4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter\n5. Current alcohol or substance use disorder or dependence (DSM 5 criteria).\n6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.\n7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.\n8. Has a history of anaphylaxis from vitamin B3 derivatives\n9. BMI \\> 42.5 kg\u002F m2\n10. Non-ambulatory","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The aim of the study is to determine the safety and tolerability of different increasing doses of MIB-626 (a microcrystalline form of β nicotinamide mononucleotide; NMN) given daily for 28 consecutive days to adults with Down syndrome (DS). The study will also explore how the drug moves through the body over time (pharmacokinetics or PK) and how the drug affects the body in different ways (pharmacodynamics or PD). The study participants will be monitored for adverse events and measurements to detect safety events will take place including laboratory tests of blood counts, chemistries and coagulation profile, and electrocardiogram (ECG). The trial will enroll a total of 24 adults with DS who are 18 years or older and are medically stable. People enrolled in the study will be randomly assigned to receive either the active intervention (MIB-626) tablets, or placebo tablets for 28 days. Study participants will be followed for an additional 28 days (total 56 days of follow-up). This study will also explore the effect of MIB-626 on different measures associated with aging and risk of Alzheimer's Disease (AD).",[26],"Down Syndrome (DS)",[28,29,30],"Down Syndrome","NMN","safety","NOT_YET_RECRUITING","2026-06-24",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":20},"2026-07-31",{"date":39,"type":20},"2028-06-30",{"name":41,"class":42},"Brigham and Women's Hospital","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100586174","phase-4-amyloid-lowering-for-alzheimers-in-downs-with-donanemab-investigation-100586174","NCT06911944","Amyloid Lowering for Alzheimer's in Down's With Donanemab Investigation","A Randomized, Double-Blind, Placebo-Controlled, Phase 4 Dose-Escalation Study Evaluating the Safety, Tolerability, and Efficacy of Donanemab in Adults With Down Syndrome","ALADDIN","Inclusion Criteria:\n\n1. Documentation of the participant's informed consent to study procedures\n2. Ages 35-50 years (inclusive).\n3. Plasma Phosphorylated tau (pTau) 217 levels at screening consistent with amyloid PET eligibility.\n4. Diagnosis of Down syndrome (including trisomy 21, mosaic trisomy 21, Robertsonian translocation trisomy 21, or partial trisomy 21) as confirmed by medical record review or Karyotype genetic testing.\n5. Intelligence quotient (IQ) equal to or greater than 40 based on Kaufman Brief Intelligence Test, Second Edition.\n6. Participants must be in good general health as evidenced by medical history with no diagnosis of dementia.\n7. Elevated brain amyloid (\\>18 centiloids) at screening.\n8. Stable dose of permitted medications as described protocol for 4 weeks prior to screening.\n9. In the opinion of the site PI, has a study partner able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week) for the duration of the study.\n10. As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy sufficient for compliance with required testing procedures.\n11. Must complete all screening evaluations as outlined in protocol\n\nExclusion Criteria:\n\n1. Females who are lactating or pregnant (as confirmed by a urine pregnancy test) during screening, or plan to become pregnant during the study.\n2. Females of childbearing potential or males with a female partner of childbearing potential who did not use a highly effective method of contraception within 28 days of screening alongside with a suitable barrier method (e.g., male condom) and\u002For are not willing to use both methods for the duration of their participation in the study and for 3 months after the last dose of study drug.\n3. Weight less than 40kg at screening.\n4. Lack of good venous access such that intravenous (IV) drug delivery or multiple blood draws would be precluded.\n5. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to humanized monoclonal antibodies or any components of the study treatments (donanemab or placebo).\n6. Previous treatment with donanemab unless there is firm evidence that the participant received placebo only.\n7. Prior or current treatment with a prohibited medication as described in protocol.\n8. Enrollment in another investigational study, or intake of investigational drug, within 30 days prior to screening or five half-lives of the investigational drug, whichever is longer.\n9. MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or evidence of a prior macro-hemorrhage, or showing more than one (1) cerebral microhemorrhage (regardless of their anatomical location with a diagnostic characterization as \"definite\"), evidence of space occupying lesions, more than two (2) lacunar infarcts, or one (1) infarct larger than 1cm in diameter, severe white matter disease, and structural evidence of alternative pathology not consistent with AD and considered to be at the origin of participant's symptoms.\n\n   NOTE: Small incidental meningiomas and arachnoid cysts (\\\u003C1cm in diameter) may be permitted with Medical Monitor review and approval.\n10. Contraindication(s) to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker or other devices that are not compatible with MRI, and\u002For severe claustrophobia.\n11. Contraindications to amyloid positron emission tomography (PET) imaging and\u002For use of florbetapir.\n12. Any unstable and\u002For clinically significant medical condition likely to hamper the evaluation of safety and\u002For efficacy of study drug (e.g., moderate and\u002For severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per the site PI's judgement.\n13. History of severe allergic reaction (e.g., anaphylaxis) including, but not limited to: severe allergic reaction to previous vaccines, foods, and\u002For medications.\n14. Hospitalization within 30 days prior to screening or baseline.\n15. Clinically significant infections or major surgical operation within 3 months prior to screening.\n16. History of chronic or recurrent infections judged to be clinically significant by the site PI and which would potentially hamper the evaluation of efficacy and safety assessments.\n17. Myocardial infarction within one (1) year prior to baseline, unstable angina pectoris, or significant coronary artery disease.\n18. History of cancer within the past five (5) years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer, which have been fully removed and are considered cured.\n19. History or presence of immunological or inflammatory conditions, including neurological disorders, judged to be clinically significant by the site PI.\n20. History of meningitis or meningoencephalitis.\n21. History of moderate or severe traumatic brain injury.\n22. History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years prior to study screening. The use of antiepileptic medications is permitted.\n23. Concomitant or past history of psychiatric or neurologic disorder (e.g., head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and\u002For non-hemorrhagic stroke) other than those considered to be related to AD.\n24. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) criteria for drug or alcohol abuse or dependence currently met within the past 5 years.\n25. Significant risk of suicide defined, using the Columbia-Suicide Severity Rating Scale (C-SSRS) (Child Version), as the participant answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 12 months.\n26. Clinically significant abnormal vital signs including sustained sitting blood pressure \\>160\u002F90 millimeters of mercury (mmHg).\n27. Participants with diabetes mellitus with hemoglobin A1c (HbA1c) levels of ≥8.0%.\n28. In the opinion of the site PI, clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures.\n29. Participants with a known history of human immunodeficiency virus (HIV-1 and 2).\n30. Participants with known history of acute\u002Fchronic hepatitis B or C.\n31. Clinically significant arrhythmias or other clinically significant abnormalities on electrocardiogram (ECG) at screening (minor abnormalities documented as clinically insignificant by the site PI are allowed).\n32. Residing in a continuous care nursing facility.\n33. For participants undergoing Lumbar Puncture (LP) as part of the optional longitudinal cerebrospinal fluid (CSF) biomarker sub-study, any contraindication to LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; international normalized ratio (INR) \\>1.4 or other metrics indicating coagulopathy; platelet count of \\\u003C120,000\u002Fmicroliter(μL); infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of LP (Note: low dose (up to 81 milligram (mg)) aspirin is permitted); degenerative arthritis of the lumbar spine; suspected or known non-communicating hydrocephalus or intracranial mass, or elevated intracranial pressure from any cause; prior history of spinal mass or trauma.\n34. Participants unwilling to learn their APOE genotype and\u002For amyloid PET scan results\n35. Participants who are apolipoprotein E ε4 (APOE ε4) homozygotes.\n36. Participants who receive anti-coagulants or thrombolytics within 30 days prior to baseline. Any use of anticoagulants or thrombolytics during the study will lead to discontinuation of the study drug.\n37. Participants with clotting disorders.\n38. Any condition, which in the opinion of the site PI, Coordinating Center, regulatory sponsor, or Project Lead\u002FProtocol PI, makes the participant unsuitable for inclusion.","35 Years","50 Years",{"count":55,"type":20},60,[57],"PHASE4","The goal of this clinical trial is to learn if donanemab can reduce levels of amyloid in the brain, and if donanemab is safe and well-tolerated in participants with Down syndrome.\n\nThe main questions it aims to answer are: Does donanemab reduce amyloid in the brain? Is donanemab safe and well-tolerated in people with Down syndrome? Researchers will compare donanemab to a placebo (a look-alike substance that contains no drug) to see if donanemab works to reduce levels of amyloid in the brain.\n\nParticipants in the study will be 35-50 years old and will be in the study for 12 months. Participants will then stay in the study for an additional 12 months in an long-term extension where all participants will receive donanemab. Participants who had a reduction in amyloid (measured by amyloid brain scan) by the end of the first 12 months will receive placebo for the long-term extension, while participants who did not have an amyloid reduction will receive study donanemab for the long-term extension. Everyone (participants and study staff) will remain blinded to treatment for the duration of the study.\n\nParticipants will:\n\n* Have intravenous (IV) infusions of donanemab (or placebo) every 4 weeks\n* Visit the clinic once every other month for checkups and tests. These tests will include brain scans (magnetic resonance imaging \\[MRI\\] and positron emission tomography \\[PET\\] ), blood draws and memory tests.\n* Have a study partner who who can provide information about the participant and can join participant for some of the study visits.",[26,60,61,62],"Down Syndrome (Trisomy 21)","Alzheimer Disease","Amyloid Beta Protein","2026-05-13",{"date":65,"type":35},"2026-05-15",{"date":67,"type":20},"2026-08-01",{"date":69,"type":20},"2028-12-31",{"name":71,"class":42},"Michael Rafii, MD, PhD",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":94,"locationsCount":96},"100625679","adapting-rdad-for-ds-100625679","NCT07425769","Adapting RDAD for DS","Adapting the RDAD Intervention for Individuals With Down Syndrome Phase 3- Pilot Test","CareFit DS\u002FAD","Inclusion Criteria - Adults with Down syndrome:\n\n* Age \\>35 yrs. with a diagnosis of DS as self-reported or reported by caregiver. This age range was selected as cognitive decline related to AD is observed at age \\~31 in adults with DS.\n* Sufficient functional ability to understand directions, communicate preferences, wants, and needs through spoken language.\n* Living at home or in a supported living environment with a parent\u002Fcaregiver who agrees to serve as a study partner.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Adults with Down syndrome:\n\n* Unable to participate in moderate-to-vigorous physical activity.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.\n\nInclusion Criteria - Caregivers\n\n* Age ≥18 yrs.\n* Reports being a primary caregiver of an adult with DS.\n* English speaking.\n* Self-reported ability to participate in physical activity.\n\nExclusion Criteria - Caregivers\n\n* Unable to participate in moderate PA, i.e., brisk walking.\n* Self-reported, cardiovascular, metabolic or renal disease and\u002For signs or symptoms.",{"count":81,"type":20},40,[83],"NA","The goal of this clinical trial is to observe feasibility and initial efficacy of a remotely delivered exercise and dementia caregiving intervention in older adults with Down syndrome and their caregivers.",[26,86],"Alzheimer's Disease (AD)","RECRUITING","2026-05-05",{"date":90,"type":35},"2026-05-06",{"date":92,"type":35},"2026-03-31",{"date":37,"type":20},{"name":95,"class":42},"University of Kansas Medical Center",1,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":103,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":125,"locationsCount":127},"100603334","phase-3-compassionate-use-study-of-epi-on-corneal-collagen-crosslinking-performed-using-uva-exposure-on-eyes-with-ectatic-corneal-diseases-for-subjects-with-down-syndrome-100603334","NCT07135167","Compassionate Use Study of Epi-ON Corneal Collagen Crosslinking Performed Using UVA Exposure on Eyes With Ectatic Corneal Diseases for Subjects With Down Syndrome","Inclusion Criteria:\n\n1. Be at least 8 years of age or older, male or female, of any race.\n2. Have a diagnosis of Down syndrome or other cognitive, developmental, or medical conditions that precludes the subject from reliably following instructions or performing some of the study examination procedures.\n3. Have a diagnosis of keratoconus, pellucid marginal degeneration, progressive ectasia after previous CXL treatment, other ectatic condition, or forme fruste keratoconus based on topography, tomography, and slit lamp examination.\n4. Provide written informed consent and a signed HIPAA form. Pediatric subjects less than 14 years of age must sign an assent, and a parent or legal guardian must sign an informed consent. If the subject has impaired consent capacity, determined by the consenter, the consent form must be signed by the subject's legally authorized representative on behalf of the subject.\n5. Satisfactory completion of the standardized clinical decision tool evaluation of patient suitability for CXL. (See Section 7.2.3)\n6. Be willing and able to follow all instructions to the best of his\u002Fher abilities and comply with the schedule for follow-up visits.\n\nExclusion Criteria:\n\n1. Normal corneal topography.\n2. A history of previous corneal transplant in the study eye.\n3. Minimum corneal thickness \\\u003C 300 (measured by Pentacam and Ultrasound) at the screening exam.\n4. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye to future complications or prevent the possibility of improved vision, for example:\n\n   1. History of, or active, corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)\n   2. Clinically significant corneal scarring in the central cornea that, in the investigator's opinion, will not allow the subject to achieve functional vision, even with contact lens correction, after the crosslinking procedure.\n5. A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.\n6. Nystagmus or any other condition that would prevent a steady gaze during the crosslinking treatment or other diagnostic tests.\n7. If female, pregnant, lactating or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of either eye during the course of the study. \\[NOTE: If female and capable of becoming pregnant, must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue one month following treatment. \\]\n\n7\\. Inability to remove soft or scleral contact lenses at least 3 days before initial and follow-up examinations.\n\n8\\. Inability to remove rigid gas-permeable contact lenses at least 2 weeks before initial and follow-up examinations.\n\n9\\. Inability to return for required postoperative examinations. 10. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for crosslinking or study participation or may confound the outcome of the study.","8 Years",{"count":105,"type":20},225,[107],"PHASE3","The goal of this clinical trial is to study the effects of an experimental (not Food and Drug Administration (FDA)-approved) treatment called corneal crosslinking (CXL) for conditions in which the cornea becomes progressively thin, steep, and misshapen, causing vision to be blurred.\n\nCXL is performed by putting riboflavin (vitamin B2) drops onto the eye and then exposing it to ultraviolet (UVA) light at about the same intensity as you get outdoors on a bright, sunny day. It is designed to stop the progression of disease by strengthening the cornea. Study participants will be 8 years of age or older and have a diagnosis of Down syndrome.\n\nThe main question it aims to answer is:\n\n* Does CXL help prevent or slow the progression of someone's corneal condition and vision loss?\n\nParticipants will:\n\n* Attend up to a total of 7 in office visits over the course of 6 months, where several eye and vision tests will be given.\n\nReceive CXL (applying riboflavin (Vitamin B2 eye drops) to the eye, then exposing the eye to ultraviolet (UV-A) light for 20 minutes).",[26,110,111,112],"Keratoconus","Pellucid Marginal Degeneration","Forme Fruste Keratoconus (FFK)",[114,115,116,117,118],"corneal crosslinking (CXL)","cornea","riboflavin","vitamin B2","ultraviolet","2026-01-29",{"date":121,"type":35},"2026-02-02",{"date":123,"type":35},"2025-08-01",{"date":69,"type":20},{"name":126,"class":42},"Woolfson Eye Institute",12,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":96},"100609321","effects-of-chronic-creatine-and-beta-hydroxy-beta-methylbutyrate-supplementation-on-oxidative-stress-inflammation-muscle-strength-and-body-composition-in-individuals-with-down-syndrome-100609321","NCT07213063","Effects of Chronic Creatine and Beta-Hydroxy-Beta-Methylbutyrate Supplementation on Oxidative Stress, Inflammation, Muscle Strength, and Body Composition in Individuals With Down Syndrome","Inclusion Criteria:\n\n* Diagnosis: Medical confirmation of Down syndrome (trisomy of chromosome 21).\n* Physical capacity: Ability to perform basic physical tests (e.g., standing up from a chair or walking without assistance).\n* Informed consent: Informed consent will be obtained from both the participant and their legal representative, in compliance with current legislation for individuals requiring support measures.\n\nExclusion Criteria:\n\n* Chronic kidney disease: Diagnosis of chronic kidney disease.\n* Severe motor limitations: Inability to perform the required physical tests (e.g., paralysis or mobility impairments preventing the execution of muscle strength assessments).\n* Participation in other studies: Participation in another nutritional or supplementation intervention study within the last 6 months.\n* Allergies or intolerances: Known allergy to creatine or to components of the placebo (inulin).",{"count":135,"type":20},50,[83],"Purpose:\n\nThis study will test whether 8 weeks of creatine and HMB supplementation can improve muscle strength, body composition, balance, and overall health in people with Down syndrome. Participants will also receive nutrition tips during the study.\n\nWho can participate:\n\nPeople with Down syndrome who can perform basic physical tasks. Must provide consent from the participant and legal guardian.\n\nWhat participants will do:\n\nTake creatine (3 g\u002Fday) and HMB (3 g\u002Fday) or placebo for 8 weeks. Complete tests for muscle strength, balance, and cognitive function. Undergo body composition scans and give blood samples for health markers.\n\nTiming:\n\nAll tests and blood samples are taken before and after each 8-week period.\n\nImportance:\n\nResults will help determine if creatine and HMB can safely improve strength, balance, and overall health in people with Down syndrome.",[26,139],"Supplementation",[141,142,143],"creatine","down syndrome","bone mineral health","2026-01-12",{"date":146,"type":35},"2026-01-14",{"date":148,"type":35},"2025-09-15",{"date":150,"type":20},"2026-05-30",{"name":152,"class":42},"Universidad de Burgos",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":161,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":173,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":197},"100610985","phase-3-levetiracetam-to-prevent-seizures-in-symptomatic-alzheimers-disease-in-adults-with-down-syndrome-100610985","NCT07234695","LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome","A Phase III, Randomized, Double-blinded Study of the Efficacy and Safety of LEvetiracetam to Prevent Seizures in Symptomatic Alzheimer's Disease in Adults With Down Syndrome (the LESS-AD Trial).","LESS-AD","Inclusion Criteria:\n\n* Diagnosed with Down Syndrome (DS), either with a karyotype or a compatible typical phenotype.\n* Age over 40 years at time of screening.\n* Symptomatic Alzheimer's Disease (AD) dementia, based on change in functionality and neuropsychological tests' results. Different cut-off points will be established to diagnose dementia depending on the level of intellectual disability of the individual, according to previous experience (Benejam et al; 2020): in adults with mild intellectual disability, a CAMCOG-DS score of 80 and an mCRT score of 29 will be chosen, whereas values of 56 and 28, respectively, will be used in subjects with moderate intellectual disability. Doubtful cases (e.g., with compromised functionality, but without alteration in the neuropsychological assessment) or those unable to complete the evaluation will be categorized by consensus among expert clinicians, using all available clinical information.\n* Willing and able caregiver who has daily contact with the study subject.\n* Subjects and caregivers must be able to comply with the prescribed regimen of study treatment throughout the course of the study and meet a minimum required time commitment of biannual in-person visits.\n* Any concurrent treatment for AD approved by the European Medicines Agency (EMA) must be stable for at least 30 days prior to screening and at least 60 days prior to study day 1. Other medications (except for those listed under exclusion criteria) are allowed as long as the dose is stable for 30 days prior to screening.\n* Subjects and\u002For their caregivers must be able to provide their consent before participating in any study-related procedures.\n\nExclusion Criteria:\n\n* Cognitive changes attributable to causes other than AD (for example, but not limited to, uncorrected visual or hearing deficit, severe, untreated sleep apnea or uncontrolled thyroid disorders).\n* Previous history of adult-onset epileptic seizures (over 18 years old).\n* Treatment with any kind of antiepileptic drugs, benzodiazepines, narcotics.\n* Significant comorbidities or analytical abnormalities, such as:\n* Any unstable and\u002For clinically significant medical condition likely to hamper the evaluation of safety and\u002For efficacy of the study (eg, moderate and\u002For severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgement.\n* Severe renal dysfunction (creatinine clearance \\\u003C 30 mL\u002Fmin), which would affect serum levetiracetam levels, or any other medical condition which is determined by the investigators to potentially create an undue risk for an adverse effect.\n* Concomitant or past history psychiatric or neurologic disorder other than those considered to be related to AD (eg, head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks \\[TIAs\\]).\n* Significant risk of suicide, defined using the C-SSRS as the subject answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 12 months.\n* Deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, judged to be clinically significant by the investigator.\n* Participation in another clinical trial within 3 months of screening.\n* Hypersensitivity to the active ingredient, other pyrrolidone derivatives, or any of the excipients\n* Pregnant and breastfeeding patients","40 Years",{"count":163,"type":20},120,[107],"The purpose of this study is to evaluate whether levetiracetam can prevent epileptic seizures in patients with Alzheimer's disease associated with Down syndrome. It will also analyze whether it can delay the neurodegeneration associated with this disease.\n\nPatients will be randomly assigned to one of two groups: one group will receive the active drug (levetiracetam), and the other will receive a placebo.\n\nBoth groups will receive the treatment for 96 weeks. Each patient will participate for a total of 2 years and 5 months.",[28,26,60,167,168,61,169,170,171,172],"Alzheimer Dementia","Alzheimer Dementia (AD)","Alzheimer Disease (AD)","Alzheimer Blood Biomarkers","Epilepsy","Seizures",[174,175,176,177,178,179,180,181,182,183,184,185,186,187,188],"Down syndrome","epilepsy","Alzheimer","dementia","levetiracetam","prevention","placebo-controlled","epileptic seizures","Alzheimer's disease markers","phase III","randomized","double-blind","bilateral tonic-clonic seizure","217-pTau","NfL","2026-01-08",{"date":144,"type":35},{"date":192,"type":20},"2025-12-22",{"date":194,"type":20},"2028-07",{"name":196,"class":42},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",5,{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":206,"maxAge":17,"enrollmentInfo":207,"targetDuration":4,"studyType":21,"phases":209,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":96},"100610788","phase-3-the-efficacy-of-therapy-in-patients-with-acute-myeloid-leukemia-and-down-syndrome-in-russia-100610788","NCT07232134","The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia","Prospective Non-randomized Multicenter Trial: the Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia","AML-DS-2025","Inclusion Criteria:\n\n* Age 0-18 years\n* Diagnosis of AML, MDS and presence of Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Children with Down syndrome and acute lymphoblastic leukemia (ALL)\n* Severe comorbidities with contraindications to the treatment according to the protocol\n* Pre-treatment \\>14 days with intensive induction therapy\n* Refusal of all therapy or important elements of therapy","1 Day",{"count":208,"type":20},100,[107],"This prospective non-randomized multicenter trial created based on protocol ML DS 2006 and aimed at standardization of current therapy approaches and creating a national network for diagnostic, treatment and monitoring of children (0-18 years) with AML and Down syndrome in Russia. Based on the results the investigators expect to increase long-term overall and event-free survival in children with AML and DS and reduce the immediate and remote toxicity of chemotherapy by reducing the dose load of chemotherapeutic drugs.\n\nThe study protocol therapy for all patients includes four chemotherapy blocks:\n\nCourse 1 AIE (cytarabine\u002Fidarubicin\u002Fetoposide) Course 2 AI (cytarabine\u002Fidarubicin) Course 3 HAD (high -dose cytarabine (1g)\u002Fdaunorubicin) Course 4 HA (high-dose cytarabine) Safety to be monitored based on CTCAE v5.0",[212,26],"AML (Acute Myelogenous Leukemia)",[214,215,28,216],"AML","Acute Myelogenous Leukemia","DS","2025-11-17",{"date":219,"type":35},"2025-11-20",{"date":221,"type":35},"2025-07-24",{"date":223,"type":20},"2032-12-30",{"name":225,"class":42},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":234,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":21,"phases":238,"briefSummary":239,"conditions":240,"keywords":241,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":246,"lastUpdatePostDateStruct":247,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":96},"100605535","the-effect-of-the-hep-approach-in-infants-with-down-syndrome-100605535","NCT07163780","The Effect of the HEP Approach in Infants With Down Syndrome","The Effectiveness of the HEP (Homeostasis-Enrichment-Plasticity) Approach in Infants With Down Syndrome","HEP-DS","Inclusion Criteria:\n\n* Must be between 4 and 12 months old\n* Must have been diagnosed with Down Syndrome\n* Must not be at any neurological risk\n* Parent must agree to participate regularly in the study process\n\nExclusion Criteria:\n\n* History of intraventricular hemorrhage (Grade III or IV)\n* Major vision or hearing impairment\n* History of febrile convulsion\n* Medical conditions (e.g., oxygen dependence) that prevent active participation in the study\n* Participation in other experimental rehabilitation studies","4 Months","12 Months",{"count":237,"type":20},26,[83],"This study evaluates the effect of the HEP (Homeostasis-Enrichment-Plasticity) approach on motor and sensory development in infants with Down syndrome. Thirty-two infants will receive either HEP or traditional therapy over 12 sessions, and outcomes will be measured using standardized developmental tests.",[26],[28,242,243,244,245],"Infants","Early Intervention","Neuroplasticity","Environmental Enrichment","2025-11-13",{"date":248,"type":35},"2025-11-14",{"date":250,"type":35},"2025-09-03",{"date":252,"type":20},"2025-12-03",{"name":254,"class":42},"Izgi Miray Demirbag",{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":16,"minAge":262,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":21,"phases":265,"briefSummary":266,"conditions":267,"keywords":270,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":96},"100600748","using-technologies-to-promote-healthy-lifestyles-in-adolescents-with-intellectual-disabilities-100600748","NCT07101523","Using Technologies to Promote HEalthy Lifestyles in Adolescents With Intellectual Disabilities","IDHEAPP","Inclusion Criteria:\n\n* Diagnosis of intellectual disability\n* Being able to follow basic instructions\n* Age between 4-30 years old\n\nExclusion Criteria:\n\n* presence of severe sensory or motor impairments\n* medical conditions that contraindicated moderate physical activity\n* unable to access an smartphone during the intervention","4 Years","30 Years",{"count":55,"type":20},[83],"IDHEApp will implement various educational technology tools and work with the families, teachers and caregivers to increase physical activity (PA) and improve healthy eating. Due to the current COVID-19 pandemic restrictions, the use of innovative digital technology can contribute not just to distance learning but also to support families and students in remote. However, both healthy habits and technologies are insufficiently addressed in the population with IDD. These needs are in line with the following objectives of the Erasmus+ programme: a) Inclusion and diversity in all fields of education, training, youth and sport; b) Addressing digital transformation through development of digital readiness, resilience and capacity, and c) Encouraging the participation in sport and physical activity.\n\nEducators will find innovative possibilities and the right instruments that will enable them to fulfil their potential through innovative online education \\& learning \\& training skills module for lifestyle promotion and others available on the app. Furthermore, mentors and others health professionals (e.g., nursing etc.) will be equipped with knowledge and skills on how to use the app to teach practical skills for PA enhancement in an evidence-based way. Consequently, this project will contribute to \\[specific objectives - SO\\]:\n\n\\- Raise awareness of the importance of healthy and active living among young Europeans with intellectual disabilities.\n\nDifferent workshops and bigger events (i.e., international conference), together with the involvement of numerous participants from the institutions of this consortium will be ensured. Further, a sensitized community will participate through the social networks and the website itself, in the proposed activities.\n\n\\- Provide digital resources and tools to the partner entities of the exchange to improve lifestyle of young people with intellectual disabilities.\n\nBest Practices to provide high quality, inclusive digital health education with the best educational technology tools and methodology. A website, a mobile app and different electronic guidelines will be delivered.\n\n\\- Analyze the current state of use and acceptance of technologies as support in the management of health in adolescent with intellectual disabilities.",[268,26,269],"Intellectual Disabilities (F70-F79)","Autism Disorder",[271,272,273,274,275,276,277],"Intellectual Disabilities","Physical Activity","Sedentary Behavior","mHealth","Health Behavior Change","Health Promotion","Lifestyle Intervention","2025-08-02",{"date":280,"type":35},"2025-08-07",{"date":282,"type":35},"2024-01-01",{"date":284,"type":20},"2025-09-01",{"name":286,"class":42},"University of Seville",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":16,"minAge":293,"maxAge":17,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":295,"briefSummary":296,"conditions":297,"keywords":299,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":307,"lastUpdatePostDateStruct":308,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":317},"100581517","pediatric-down-syndrome-post-approval-study-100581517","NCT06851338","Pediatric Down Syndrome Post-Approval Study","Inclusion Criteria:\n\n1. Patient has been diagnosed with Down syndrome;\n2. Patient is 13-18 years of age;\n3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG);\n4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance;\n5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy;\n6. Treatment of patient's OSA has followed standard of care in considering all other alternative\u002Fadjunctive therapies;\n7. Patient, and their parents\u002Fguardians, is willing to have stimulation hardware permanently implanted, and be willing to participate in follow-up visits, postoperative in-lab sleep studies (PSGs), and questionnaire completion.\n\nExclusion Criteria:\n\n1. Patient's recent PSG (within 6 months of enrollment) reports central + mixed apneas \\> 25% of the total apnea-hypopnea index (AHI);\n2. Patient has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;\n3. Patient has any condition or procedure that has compromised neurological control of the upper airway;\n4. Patient, or their parent\u002Fguardian, is unable or does not have the necessary assistance to operate the patient remote;\n5. Patient is pregnant or plans to become pregnant;\n6. Patient has an implantable device that may be susceptible to unintended interaction with the Inspire system;\n7. Patient will require magnetic resonance imaging (MRI) other than what is specified in the MR conditional labeling;\n8. Patient has a terminal illness with life expectancy of less than 12 months;\n9. Any other reason the investigator deems the patient is unfit for participation in the study.","13 Years",{"count":55,"type":20},[83],"The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.",[298,26],"Pediatric Obstructive Sleep Apnea",[300,301,28,302,303,304,305,306],"Pediatrics","OSA","Pediatrics OSA","Obstructive Sleep Apnea","Long-term follow-up","Post Approval Study","PAS","2025-02-24",{"date":309,"type":35},"2025-02-28",{"date":311,"type":20},"2025-02",{"date":313,"type":20},"2030-05",{"name":315,"class":316},"Inspire Medical Systems, Inc.","INDUSTRY",6,{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":11,"sex":16,"minAge":326,"maxAge":327,"enrollmentInfo":328,"targetDuration":4,"studyType":21,"phases":329,"briefSummary":330,"conditions":331,"keywords":332,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":43},"100573589","suspension-therapy-effects-on-mobility-and-balance-in-down-syndrome-100573589","NCT06748248","Suspension Therapy Effects on Mobility and Balance in Down Syndrome","Effects of Suspension Therapy on Mobility and Balance in Children With Down Syndrome","STOMP","Inclusion Criteria: • Diagnosed children with Down syndrome with mild (IQ: 69-50) to moderate (IQ: 50-35) mental retardation\n\n* Aged between 3 to 6 years\n* Both gender\n* Able to follow the instructions\n* Able to stand and walk\n\nExclusion Criteria: • Any Cardiovascular disease\n\n* Visual and Hearing impairment\n* Orthopedic limitation to exercise such as hip, knee, foot or spinal deformities","3 Years","6 Years",{"count":237,"type":20},[83],"Down syndrome (DS) is one of the most common congenital disorders. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. These factors are responsible for the developmental challenges faced by children with Down syndrome. These individuals also present with balance dysfunctions. Neuromuscular and musculoskeletal impairments due to the chromosomal abnormality lead to developmental delay. These children also exhibit poor balance with greater instability and inefficient compensatory mechanisms including altered center of pressure displacement and trunk stiffening that predisposes them to falls. The aim of this study is to determine the Effects of Suspension Therapy (ST) on mobility and balance of children with Down syndrome. Suspension Therapy using Universal exercise Unit (UEU) is a three dimensional (3D) cage, consists of system of pulleys, suspensions, belts for supporting and elastic cords. Suspension Therapy is based on the concept of unloading the body against gravity and to perform movement of weak part of body.",[26],[174,333,334,335,336,337,338],"Suspension Therapy","Universal Exercise Unit","Pediatric Balance Scale","four Square Step Test","1min Walk Test","Timed up and go test","2024-12-20",{"date":341,"type":35},"2024-12-27",{"date":343,"type":35},"2024-09-24",{"date":345,"type":20},"2025-01-15",{"name":347,"class":42},"Riphah International University"]