[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"down-syndrome-trisomy-21\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:down-syndrome-trisomy-21":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,50,88,120,147,175,201,270,295,323,368],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100641242","effects-of-a-pacifier-on-obstructive-sleep-apnea-and-its-repercussions-in-infants-with-down-syndrome-100641242",false,"NCT07658053","Effects of a Pacifier on Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome","Effects of a Pacifier on the Development of Obstructive Sleep Apnea and Its Repercussions in Infants With Down Syndrome","TET21","Inclusion Criteria:\n\n* Group 1 (infants with CURAPROX pacifier)\n\n  * Age 1 month (±1 week)\n  * Children diagnosed with free and homogeneous trisomy 21\n  * For whom a consultation is planned at \\~1 month in the department of genetics\n  * Affiliated to a social security scheme\n  * With informed consent of the 2 legal representatives\n* Group 2 (infants without CURAPROX pacifier)\n\n  * Infants included in the OMF21 study (sponsored by HCL, n°ID-RCB 2025-A01900-49, approved by ethical committee Nord-Ouest IV on October 9th 2025)\n  * With informed consent of the 2 legal representatives for re-use of the data\n\nExclusion Criteria:\n\n* Group 1 (infants with CURAPROX pacifier)\n\n  * Diagnosed with mosaic trisomy 21\n  * Born preterm (gestation age at birth \\\u003C37 weeks)\n  * Known allergy to silicone\n  * Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies\n* Group 2 (infants without CURAPROX pacifier) - Use of the CURAPROX pacifier for ≥1 month","ALL","23 Days","38 Days",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system.\n\nDown Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study, OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. Therefore, there is a need to develop new strategies to prevent OSA early in infancy.\n\nOSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly.\n\nThe primary objective of the present study is to evaluate the effects of a pacifier used by infants with Down Syndrome (from the age of 1 months) on the severity of OSA at the age of 6 months, by comparing a group of infants with the pacifier vs a group of infants without the pacifier.\n\nThe main hypothesis is that infants who used the pacifier from 1 month- to 6 month-old will have lower OSA severity (estimated by the obstructive apnea hypopnea index on polysomnography (PSG)).",[28,29],"Obstructive Sleep Apnea","Down Syndrome (Trisomy 21)",[31,32,33,34,35,36],"Sleep apnea","Down syndrome","Oro-myo-functional development","Sleep","Non-nutritive sucking","Pacifier","NOT_YET_RECRUITING","2026-06-16",{"date":40,"type":41},"2026-06-18","ACTUAL",{"date":43,"type":22},"2026-07-01",{"date":45,"type":22},"2029-01-01",{"name":47,"class":48},"Hospices Civils de Lyon","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100642613","the-advance-assay-development-and-validation-for-pre-natal-and-obstetric-conditions-study-is-the-largest-us-based-prospective-study-demonstrating-a-circulating-fetal-cell-cfc-based-approach-to-non-invasive-fetal-risk-assessment-100642613","NCT07643896","The ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) Study is the Largest U.S.-Based Prospective Study Demonstrating a Circulating Fetal Cell (CFC) Based Approach to Non-invasive Fetal Risk Assessment","ADVANCE Study: Assay Development and Validation for Pre-Natal and Obstetric Conditions","ADVANCE","Inclusion Criteria:\n\n* pregnant individuals between 10 and 20 weeks of gestation\n* singleton gestation\n\nExclusion Criteria:\n\n\\- active cancer","FEMALE",{"count":60,"type":22},1000,"OBSERVATIONAL","The goal of the ADVANCE (Assay Development and Validation for Pre-Natal and Obstetric Conditions) study is to compare the concordance of results of a novel non-invasive circulating fetal cell (CFC) assay to the results of prenatal invasive diagnostic testing or postnatal genetic and clinical diagnosis of the resulting neonate. This is a prospective study of pregnant individuals.",[64,65,29,66,67,68,69],"Pregnant Individuals","Aneuploidy","22q11.2 Deletion Syndrome","Trisomy 13","Trisomy 18","Sex Chromosome Abnormalities",[71,72,73,74,75],"pregnant","aneuploidy","NIPT","NIPS","circulating fetal cell","RECRUITING","2026-06-10",{"date":79,"type":41},"2026-06-12",{"date":81,"type":41},"2026-01-10",{"date":83,"type":22},"2028-06",{"name":85,"class":86},"BillionToOne Inc.","INDUSTRY",6,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":17,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":100,"studyType":61,"phases":4,"briefSummary":101,"conditions":102,"keywords":103,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":49},"100637363","vascular-function-in-adults-with-down-syndrome-100637363","NCT07630207","Vascular Function in Adults With Down Syndrome","VDS","Inclusion Criteria:\n\n* between 18 and 35 years old\n* generally healthy\n* sedentary (defined as being involved in less than 30 minutes of moderately-intense physical activity per day)\n\nAdditionally, for the participants with Down syndrome:\n\n* diagnosis of Down syndrome trisomy 21\n* normal thyroid function or stable thyroid function (and medications) for at least 6 mo.\n\nExclusion Criteria:\n\n* unresolved congenital heart disease;\n* atherosclerotic or other vascular disease (such as blood clot history or clotting disorders);\n* asthma or other pulmonary disease;\n* hypertension (defined BP \\>140\u002F90 mmHg); blood pressure below 90\u002F60 mmHg;\n* history of pre-syncope or syncope;\n* diabetes (defined as Hba1c of \\>7.5% or use of glucose lowering medication);\n* severe obesity (defined as BMI \\>40);\n* heart medications affecting heart rate, blood pressure or arterial function, including blood thinners; anti-inflammatory medication including NSAIDS;\n* current smoking;\n* currently pregnant or planning to become pregnant during the study period;\n* currently breastfeeding;\n* unable or unwilling to use an acceptable method of contraception during the study timeframe;\n* positive pregnancy test at screening.",true,"18 Years","35 Years",{"count":99,"type":22},24,"2 Days","Adults with Down syndrome (Ds) are often thought to have a lower risk of heart and blood vessel disease because they tend to have lower blood pressure and fewer heart attacks than people without Ds. However, recent research suggests that heart and blood vessel diseases, including stroke, are becoming a more common cause of death in adults with Ds as life expectancy increases. Despite these findings, studies examining heart and blood vessel health in adults with Ds have produced mixed results, making it difficult to determine their true risk and whether preventive strategies are needed. This study will investigate the health of blood vessels in adults with Ds and compare the results with those of adults without Ds. Healthy blood vessels are important because they help deliver blood and oxygen throughout the body. Changes in blood vessel function and stiffness can occur with aging and may increase the risk of heart disease, stroke, kidney disease, and memory problems. The study aims to determine whether adults with Ds experience changes in blood vessel health that may place them at increased cardiovascular risk. Specifically, the study will: (1) Examine how well blood vessels function in adults with Ds; (2) Measure the stiffness of arteries in adults with Ds; (3) Compare two methods used to assess blood vessel function to determine whether a simpler exercise-based test provides results similar to a commonly used standard test.\n\nThe findings may improve understanding of cardiovascular risk in adults with Ds and help guide future strategies to promote healthy aging in this population.",[29],[104,105,106,107,108,109,110],"Down Syndrome","Trisomy 21","Arterial stiffness","Endothelial function","vascular function","ultrasonography","arterial doppler","2026-06-01",{"date":113,"type":41},"2026-06-05",{"date":115,"type":41},"2026-04-09",{"date":117,"type":22},"2026-12-31",{"name":119,"class":48},"University of Nevada, Las Vegas",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":97,"maxAge":128,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"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.","50 Years",{"count":130,"type":22},60,[132],"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.",[135,29,136,137],"Down Syndrome (DS)","Alzheimer Disease","Amyloid Beta Protein","2026-05-13",{"date":140,"type":41},"2026-05-15",{"date":142,"type":22},"2026-08-01",{"date":144,"type":22},"2028-12-31",{"name":146,"class":48},"Michael Rafii, MD, PhD",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100618691","phase-2-aef0217-in-participants-with-down-syndrome-100618691","NCT07334912","AEF0217 in Participants With Down Syndrome","A Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase 2b Trial to Assess the Efficacy, Safety and Tolerability of AEF0217 for 24 Weeks in Adults and Older Adolescents With Down Syndrome.","Inclusion Criteria:\n\n* 1\\. Male and female. For males: Throughout the trial and until the end of the trial, male participants should refrain from donating sperm and, if sexually active, use double-barrier contraceptive methods (i.e., male condoms and spermicide), or the female partner must use the same highly effective contraceptive methods as female trial participants .\n\nFor females: Female participants of childbearing potential, defined as having a menstrual cycle that is confirmed prior to enrolment, must use highly effective contraception throughout the trial and until 3 months after the last dose of the trial intervention, be sexually abstinent, or have a vasectomized partner.\n\n* 2\\. Age ≥16 to ≤32years.\n* 3\\. BMI ≥18.0 and ≤35 kg\u002Fm2.\n* 4\\. Clinical diagnosis of Down syndrome (full trisomy 21 or translocations) documented by chromosomal analysis (karyotyping).\n* 5\\. Must be independently mobile and have sufficient vision and hearing to participate in the trial evaluations.\n* 6\\. IQ \\>35-70 measured with Leiter-3. Individuals with IQ from \\>35 to \\\u003C40 must have adequate cognitive and behavioural abilities according to the judgment of the principal investigator.\n* 7\\. VCI of WISC-V language test score \\>4, based on mental age (estimated via IQ).\n* 8.Must be able to understand most of the time and to express if he\u002Fshe does not understand to the extent that he\u002Fshe can accept the trial procedures. Must not use other forms of communication, signs, symbol boards, or devices as his\u002Fher primary form of communication.\n* 9\\. Must have a parent or other reliable caregiver who agrees to accompany the participant to all clinic visits, provide information about the participant as required by the protocol, and ensure compliance with the medication schedule and protocol requirements\n* 10.The parent or caregiver must be a constant and reliable informant with sufficient contact with the participant to have detailed knowledge of the participant's adaptive functioning to be able to answer accurately the questions asked by a neuropsychologist at the assessments.\n* 11\\. Vital signs, ECG , and safety laboratory3 parameters must be without clinically relevant abnormalities as per the judgement of the investigator, except for:\n\n  * Stable type 1 or 2 diabetes provided the participant is monitored regularly prior to and during the trial to ensure adequate glucose control.\n  * Hypothyroidism controlled by treatment so that the participant is euthyroid and T4 stable (range 77-155 nmol\u002FL) for at least 6 weeks prior to randomization. Fluctuations in TSH up to a maximum of 10 mIU\u002FL are allowed.\n* 12\\. a. Assent by the participant and consent by the legally authorized representative(s) on behalf of the participant or b. Consent by the participant in situations where consent rather than assent can be provided by the participant.\n* 13\\. Informed consent by the participant's caregiver to take on the obligations of the caregiver in this trial.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or nursing female. Down syndrome\n* 2\\. Mosaic Down syndrome or Down Syndrome Regression Disorder (DSRD). Medical history and clinical status\n* 3\\. Active or clinically relevant conditions that could, in the investigator's judgment, affect absorption, distribution, or metabolism of the trial medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance); controlled celiac disease is allowed.\n* 4\\. Clinically relevant obstructive pulmonary disease or asthma that is untreated. Patients well-controlled by treatment (inhalation or oral) for at least 6 weeks prior to screening may be included if considered safe by the investigator.\n* 5\\. Known severe obstructive sleep apnoea or if the investigator thinks that the person should be referred for a diagnosis\u002Ftreatment of obstructive sleep apnoea.\n* 6\\. Recent (≤1 year) or ongoing haematologic or oncologic disorders (mild anaemia is allowed).\n* 7\\. History of infantile spasms\u002Fconvulsions\u002Fepilepsy, severe head trauma or central nervous system infections (e.g., meningitis), except for isolated events of febrile seizures more than 8 years ago.\n* 8\\. Clinically relevant unstable gastrointestinal, renal, hepatic, endocrine (including metabolic syndrome), or cardiovascular system disease as per the investigator's judgement.\n* 9\\. Any prevailing psychiatric disorder diagnosed using the DSM-5 that dominates a person's overall clinical condition outside of Down syndrome. If symptoms consistent with a diagnosis of psychiatric illness are detected during the screening assessment (NPI-Q) and considered as dominating, the investigator may request a psychiatric evaluation. If necessary, a consultant psychiatrist will be responsible for the final diagnosis, as this is not the investigator's responsibility.\n* 10\\. Participants with secondary psychiatric disorders including conduct disorders, attention deficit hyperactivity disorder, depressive disorders, anxiety disorders, and others that: 1) dominate the overall clinical condition according to the investigator's assessment; and\u002For 2) are not stabilized by medical or behavioural treatments, a stabilized treatment being defined as a stable therapeutic regimen and dose for the 3 months prior to randomization; and\u002For 3) the type of pharmacological treatment is on the list of drugs that are prohibited.\n* 11\\. Symptoms of early dementia confirmed by the NTG-EDSD.\n* 12\\. Substance use disorder as defined by the DSM-5.\n* 13\\. Positive urine test for alcohol and drugs of abuse at screening and prior to first dosing.\n* 14\\. Current diagnosis of epilepsy.\n* 15\\. A history of intentional self-harm or suicide attempts brought on by suicidal thoughts. Suicidal ideation in the 12 months before screening, even if there was no suicide attempt or intentional self-harm. Assessed using 3 distinct questions about suicidal behaviour, suicidal ideation, and any self-harming actions.\n* 16\\. Known hypersensitivity to AEF0217 or fructose intolerance.\n* 17\\. Clinically significant illness, such as active infections, within 2 weeks prior to randomization, according to the investigator's judgment.\n* 18\\. Any current life-threatening disease.\n* 19\\. Any additional clinically significant concomitant disease, condition, or screening result that, in the investigator's opinion, could endanger the participant's safety, interfere with trial conduct and related procedures, or influence how the trial results are interpreted.\n* 20\\. Treatment with 1st generation neuroleptic drugs currently or within 3 months prior to randomization and benzodiazepines currently or in the 4 weeks prior to baseline assessments.\n* 21\\. Intake of products containing EGCG (e.g., TEAVIGO, Mega Green Tea Capsules Life Extension, or Font-UP Grand Fontaine Laboratories) currently or during the last 4 weeks prior to the baseline assessments.\n* 22\\. Treatment with medications or very regular consumption of fruits (i.e., pomelo\u002Fgrapefruit) or natural remedies (i.e., hypericum preparations) known to strongly or moderately induce or inhibit CYP3A4\u002F5 P450 isozymes..\n* 23\\. Administration of an investigational medicinal product, including AEF0217, within the last 3 months prior to randomization.","16 Years","32 Years",{"count":157,"type":22},188,[159],"PHASE2","The goal of this clinical trial is to identify if AEF0217 show an improvement in adaptive behaviors (daily life activities) in adults and older adolescents with Down Syndrome. It will also learn about the safety of AEF0217.\n\nThe main questions it aims to answer are:\n\n* Does AEF0217 improve the daily life activities of the participants after being administered daily for 24 weeks ?\n* Does AEF0217 improve fluid cognitive function (cognitive abilities that do not depend on prior knowledge) and the crystallised one (knowledge acquired through one's culture, including verbal ability and social knowledge), the quality of life and sleep of the participants after being administered daily for 24 weeks ?\n* What medical problems do participants have when taking AEF0217?\n\nResearchers will compare 3 doses of AEF0217 to a placebo (a look-alike substance that contains no drug) to see if AEF0217 improves adaptative behaviours in people with Down Syndrome.\n\nParticipants will:\n\n* Take AEF0217 or a placebo every day for 24 weeks\n* Visit the clinic 6 times with their caregiver for checkups, performing tests on a tablet and answering questionnaires.\n* Be called by phone at home 5 times to check that they are well.",[29],[104,105,163,164],"adaptative behaviour","cognitive impairments","2026-04-03",{"date":167,"type":41},"2026-04-08",{"date":169,"type":41},"2025-12-22",{"date":171,"type":22},"2027-12-31",{"name":173,"class":86},"Aelis Farma",10,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":183,"maxAge":184,"enrollmentInfo":185,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":187,"conditions":188,"keywords":189,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":49},"100607953","oro-myofunctional-characteristics-and-obstructive-sleep-apnea-in-infants-with-down-syndrome-100607953","NCT07195253","Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome","Exploring the Relationships Between Oro-myofunctional Characteristics and Obstructive Sleep Apnea in Infants With Down Syndrome","OMF21","Inclusion Criteria:\n\n(infants with Down Syndrome)\n\n* Aged 6 months (±3 weeks)\n* Diagnosed with Trisomy 21\n* Affiliated to a social security scheme\n* With informed consent of the 2 legal representatives\n\nExclusion Criteria:\n\n* Diagnosed with mosaic Down syndrome\n* Born preterm (gestation age at birth \\\u003C37 weeks)\n* Treated for OSA with Continuous Positive Airway Pressure\n* Known allergy to silicone\n* Currently participating to an interventional study protocol implying an ongoing exclusion period from other studies\n* Refusal from legal representatives.","5 Months","6 Months",{"count":186,"type":22},30,"Obstructive Sleep Apnea (OSA) is characterised by repetitive collapse of the upper airway during sleep, inducing breathing disturbances that can result in oxygen desaturation and frequent arousals. In children, OSA can have long-term consequences on the development and on the cardiovascular system.\n\nDown Syndrome (DS) is a genetic disorder associated with intellectual disability and many comorbidities. The prevalence of OSA is particularly high in patients with DS, from infancy. In a recent study by Fauroux et al. (2024), OSA was diagnosed in 97% infants and early diagnosis and intervention from the age of 6 months was associated with better neurocognitive outcome at 3 years old. However, polysomnography (PSG - the gold standard method for diagnosing OSA) is poorly accessible, highlighting the need to develop new strategies to prevent and to screen OSA early in infancy.\n\nOSA can be linked to some orofacial abnormalities presented by patients with DS. Indeed, orofacial functions and structures ca play a crucial role in OSA. For example, nose breathing allows the tongue to act as a stimulator of the transverse maxillary growth during childhood, allowing the upper airway to develop properly.\n\nThe primary objective of the present study is to explore the relationships between oro-myo-facial functions, more specifically non-nutritive sucking, and the severity of OSA in 6 months old infants with DS.\n\nThe main hypothesis is that OSA severity (estimated by the obstructive apnea hypopnea index on PSG) will be negatively correlated to non-nutritive sucking performance.\n\nData from this study could help developing easily accessible protocols for OSA screening based on simple sucking recording. Some interventions could also be tested to prevent OSA from the beginning of life, like an innovative pacifier recently developed by a French start-up to stimulate nose breathing and to promote correct positioning of the tongue.",[28,29],[190,104,191,192,193],"sleep apnea","oro-myofunctional development","sleep","non-nutritive sucking","2026-04-02",{"date":165,"type":41},{"date":197,"type":41},"2026-04-01",{"date":199,"type":22},"2028-04-01",{"name":47,"class":48},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":213,"conditions":214,"keywords":236,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":49},"100630855","intensive-multimodal-neurorehabilitation-targeting-neuroplasticity-in-pediatric-neurodevelopmental-and-chromosomal-disorders-100630855","NCT07493096","Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders","Functional and Neurodevelopmental Outcomes Following Intensive Multimodal Neurorehabilitation in Pediatric Patients With Neurodevelopmental Disorders, Including Chromosomal Abnormalities","GEN-HOPE","Inclusion Criteria:\n\n* Pediatric participants between approximately 4 and 12 years of age at the time of enrollment.\n* Diagnosed with or presenting with neurodevelopmental, neurologic, or genetic conditions, including but not limited to:\n\n  * cerebral palsy\n  * autism spectrum disorder\n  * developmental delay\n  * hypoxic ischemic encephalopathy (HIE)\n  * traumatic brain injury\n  * sensory processing disorder\n  * chromosomal or genetic abnormalities\n  * Demonstrate functional impairments in one or more neurodevelopmental domains, including:\n* motor coordination or motor planning\n* sensory processing\n* attention or executive functioning\n* oculomotor or visual processing\n* communication\n* emotional or behavioral regulation\n* activities of daily living\n* Enrolled in and able to participate in a two-week intensive therapy program consisting of approximately 2.5 hours per day\u002F 5 days per week\n\n  * Able to complete baseline and post-program clinical assessment using clinician-observed or caregiver-reported measures.\n  * Parent or legal guardian able to provide informed consent and participate in reporting functional outcomes when applicable.\n\nExclusion Criteria:\n\n* Medical instability or acute medical condition that would prevent safe participation in an intensive therapy program.\n* Severe uncontrolled seizure activity or other neurologic condition that would interfere with participation in structured therapeutic activities, as determined by the treating clinician.\n* Behavioral or psychological conditions that would prevent safe engagement in the therapy environment despite appropriate support.\n* Inability to attend or complete the full two-week intensive program.\n* Lack of sufficient baseline or post-intervention data to assess change in functional performance.\n* Concurrent participation in another structured intervention or clinical study that would confound interpretation of functional outcomes, at the discretion of the investigator.","4 Years","12 Years",{"count":212,"type":22},100,"This observational study evaluates functional and developmental outcomes in pediatric participants undergoing a two week intensive multimodal neurorehabilitation program. The program is designed for children with neurodevelopmental disorders, including but not limited to cerebral palsy, autism spectrum disorder, developmental delay, hypoxic ischemic encephalopathy (HIE), and chromosomal or genetic abnormalities.\n\nParticipants receive individualized therapy sessions for approximately 2.5 hours per day over a two week period. The intervention is not standardized but is tailored to each child's specific needs and may include components such as sensory integration, motor planning, reflex integration, oculomotor training, executive functioning activities, communication support, and other brain based therapeutic approaches.\n\nThe purpose of this study is to observe changes in functional abilities, including attention, motor coordination, emotional regulation, communication, and activities of daily living. Outcomes are assessed using clinician observation and parent reported changes before and after the intensive program, with limited follow-up when available.\n\nThis study does not assign participants to a specific treatment as part of a research protocol. Instead, it collects real world data from children already participating in a clinical therapy program to better understand potential benefits of intensive, individualized neurorehabilitation approaches.",[215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,29,232,233,234,66,235],"Neurodevelopmental Disorders","Neurodevelopmental Disorders (NDD)","Neurodevelopmental Disorders and Developmental Abnormalities","Developmental Delay (Disorder)","Cerebral Palsy (CP)","Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment","Cerebral Palsy Infantile","Cerebral Palsy Spastic Hemiplegic","Cerebral Palsy, Dyskinetic","Autism Spectrum Disorder","Autism Spectrum Disorder (ASD","Hypoxic Ischemic Encephalopathy","Hypoxic Ischemic Encephalopathy (HIE)","Traumatic Brain Injury (TBI)","Sensory Processing Disorder","Chromosomal Abnormalities","Genetic Disorders","Fragile X Syndrome (FXS)","RETT Syndrome With Proven MECP2 Mutation","Williams Syndrome","Sensorimotor Integration",[237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,254,215,255,256,257,258,259,260],"Photobiomodulation","Low-Level Laser Therapy","Vibration Therapy","Tactile Stimulation","Cognitive Training","Behavioral Therapy","Intensive Therapy","Pediatric Neurorehabilitation","Multimodal Therapy","Neuroplasticity","Sensory Integration","Reflex Integration","Motor Planning","Executive Function","Emotional Regulation","Functional Outcomes","Activities of Daily Living","High Frequency Therapy","Rehabilitation","Child Development Disorders","Occupational Therapy","Physical Therapy Modalities","Early Intervention","Cognitive Therapy","2026-03-19",{"date":263,"type":41},"2026-03-25",{"date":265,"type":41},"2026-03-01",{"date":267,"type":22},"2036-12-30",{"name":269,"class":48},"Healing Hope International",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":278,"maxAge":279,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":293,"locationsCount":49},"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","30 Years",{"count":281,"type":22},20,[25],"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.",[104,29],[32,192,286],"Mindfulness-Based Therapy for Insomnia","2026-03-18",{"date":289,"type":41},"2026-03-20",{"date":291,"type":41},"2025-03-01",{"date":171,"type":22},{"name":294,"class":48},"University of Alabama at Birmingham",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":95,"sex":17,"minAge":303,"maxAge":304,"enrollmentInfo":305,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":307,"conditions":308,"keywords":309,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":49},"100626315","the-neurocognitive-bases-of-trust-in-intellectual-disability-100626315","NCT07434037","The Neurocognitive Bases of Trust in Intellectual Disability","The Neurocognitive Bases of Trust in Intellectual Disability: Affective Evaluation, Trait Attribution, and Epistemic Vigilance","BNConfDI","Inclusion Criteria :\n\nGroup of Down Syndrom patients\n\n* Complete chromosomal trisomy of the 21st chromosome confirmed by karyotype analysis\n* Aged 13 to 29 (chronological age)\n* French as their native language\n* Having signed an informed consent form and\u002For whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nGroup of X-Fragile Syndrome\n\n* Complete mutation of the FMR1 gene by molecular analysis (more than 200 CGG triplet repeats)\n* Aged between 13 and 29 (chronological age)\n* Native French speakers\n* Having signed an informed consent form and\u002For whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nGroup of chronological age-matched control\n\n* Aged between 13 and 29\n* Native French speakers.\n* Having signed an informed consent form and\u002For whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nGroup of mental age-matched control\n\n* Aged between 3 and 9\n* Native French speakers.\n* Whose legal guardians\u002Fpatient representatives have signed the informed consent form\n* Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system\n\nExclusion Criteria:\n\nGroups of Down Syndrom and X-Fragiles patients\n\n* Inability to understand tasks\n* Significant brain malformation\n* Uncontrolled epilepsy\n* Significant hearing impairment\n* Uncorrected visual impairment\n* Refusal of the subject and\u002For legal guardians\u002Frepresentative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.\n* Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.\n\nRegarding the neuroimaging (MRI) study:\n\n* Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.\n* Inability to perform the MRI without anaesthesia.\n* Refusal by the subject and\u002For those exercising parental authority\u002Fthe subject's representative to be informed of any abnormalities detected during the MRI.\n\nGroups of typical development persons (chronological age-matched and mental age-matched)\n\n* Known acquired neurological disorders, including epilepsy.\n* History of head trauma requiring hospitalisation.\n* Known psychiatric disorders.\n* Birth complications requiring admission to a neonatal intensive care unit or prematurity of less than 35 weeks.\n* Ongoing treatment with drugs affecting the central nervous system.\n* Significant hearing impairment\n* Uncorrected visual impairment\n* Repeating a school year\n* Learning disorders requiring rehabilitation (speech therapy, psychomotor therapy or orthoptics) for more than one year.\n* Refusal of the subject and\u002For legal guardians\u002Frepresentative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.\n* Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.\n\nRegarding the neuroimaging (MRI) study (only for chronological age-matched group):\n\n* Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.\n* Inability to perform the MRI without anaesthesia.\n* Refusal by the subject and\u002For those exercising parental authority\u002Fthe subject's representative to be informed of any abnormalities detected during the MRI.","3 Years","29 Years",{"count":306,"type":22},112,"This project studies the neurocognitive basis of trust adjustment in intellectual disability (ID), a source of significant vulnerability for these patients, focusing on two target populations chosen for their specific social characteristics: people with Down syndrome, who are often described as being hypersocial, and people with Fragile X syndrome, who are often characterized by a completely opposite social behaviour profile, with a withdrawn attitude and significant social anxiety.\n\nThe three different types of mechanisms that contribute to the adjustment of interpersonal trust: affective evaluation, trait attribution, and epistemic evaluation of informants, will be studied. Affective evaluation processes recruit subcortical structures such as the amygdala and assess potential social threats in the environment. The second mechanism for selecting whom to trust consists of forming a representation of a person's dispositions, such as benevolence and competence (also known as traits), and using it to predict that person's future behaviour. Trait attribution processes recruit a cortico-cerebellar network comprising the mPFC, CRUS I and posterior lobule VI. The third mechanism, called epistemic vigilance, allows to adjust our trust in what others communicate to us. This mechanism involves linking the assessment of the reliability of individuals who communicate (based on their benevolence and competence) with the reliability of the communicated information. Epistemic assessment involves frontal areas and areas associated with the representation of mental states in order to enable the evaluation of the truthfulness of the communicated information. All of these mechanisms become functional very early on, before a child's sixth birthday. There are reasons to expect that several of these central mechanisms supporting selective trust will behave atypically in intellectual disability.",[29,232],[310,311,312,313,32,314],"Trust","Intellectual disability","Eyetracking analysis","Neuroimaging","Fragile X syndrome","2026-02-24",{"date":317,"type":41},"2026-02-25",{"date":319,"type":22},"2026-02",{"date":321,"type":22},"2029-12",{"name":47,"class":48},{"id":324,"slug":325,"hasResults":11,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":17,"minAge":331,"maxAge":4,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":336,"conditions":337,"keywords":344,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":363,"leadSponsor":365,"locationsCount":367},"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":333,"type":22},120,[335],"PHASE3","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.",[104,135,29,338,339,136,340,341,342,343],"Alzheimer Dementia","Alzheimer Dementia (AD)","Alzheimer Disease (AD)","Alzheimer Blood Biomarkers","Epilepsy","Seizures",[32,345,346,347,348,349,350,351,352,353,354,355,356,357,358],"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":361,"type":41},"2026-01-12",{"date":169,"type":22},{"date":364,"type":22},"2028-07",{"name":366,"class":48},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",5,{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":95,"sex":17,"minAge":376,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":380,"conditions":381,"keywords":385,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":49},"100596630","neuropsychological-evaluation-in-intellectual-disability-endi-100596630","NCT07047963","Neuropsychological Evaluation in Intellectual Disability (ENDI)","Neuropsychological Evaluation in Intellectual Disability","ENDI","Inclusion Criteria:\n\nPreliminary phase:\n\n1. The inclusion criteria for the group of people with intellectual disabilities are as follows:\n\n   * Participant who has received full information on the organization of the research and has not objected to his or her participation and to the use of his or her data.\n   * Legal guardian of the participant, if applicable, who has received full information on the organization of the research and has not objected to participation and use of his\u002Fher data.\n   * Age at inclusion: ≥ 25 and ≤ 65 years\n   * Notion of intellectual disability in medical records\n   * Access to the oral language of the participant with an intellectual disability: the subject's speech must be comprehensible to the evaluator and the subject must be able to understand simple statements. It is not possible to use an oral comprehension test (e.g. Token test by Renzi \\& Vignolo, 1962), as the norms achieved in healthy subjects would exclude almost all patients with intellectual disabilities, who have more limited language skills.\n   * Enrolled in or benefiting from a social security scheme.\n2. The inclusion criteria for the normotypic group are as follows:\n\n   * Participant having received full information on the organization of the research and not having objected to his or her participation and to the use of his or her data.\n   * Age at inclusion: ≥ 25 and ≤ 65 years\n   * Affiliation with a social security scheme or beneficiary of such a scheme\n\nMain phase:\n\nInclusion criteria are as follows:\n\n* Participant with T21 who has received full information on the organization of the research and has not objected to participation and use of his\u002Fher data\n* Legal guardian of the participant with T21, where applicable, who has received full information on the organization of the research and has not objected to his or her participation and the use of his or her data.\n* Person with trisomy 21\n* Age at inclusion: ≥ 25 and ≤ 65 years\n* Access to the oral language of the participant with T21: the subject's speech must be comprehensible to the evaluator and the subject must be able to understand simple statements. It is not possible to use an oral comprehension test (e.g. Token test by Renzi \\& Vignolo, 1962), as the norms achieved in healthy subjects would exclude almost all patients with intellectual disabilities, who have more limited language skills.\n* Membership of a social security scheme or beneficiary of such a scheme\n\nExclusion Criteria for both phases of the study are as follows:\n\n* Disabling motor and\u002For sensory impairments preventing completion of the tests\n* Insufficient command of the French language to complete the tests\n* Severe general medical condition or alcoholism (habitual consumption of 3 drinks\u002Fday or history of alcohol withdrawal)\n* History of stroke, severe head trauma, or cancer\n* Change in long-term medication within 8 weeks prior to evaluation\n* Refusal to participate by the subject and\u002For legal representative\n* Individuals referred to in Articles L.1121-5 to L.1121-7 of the French Public Health Code:\n\n  * Pregnant women, women in labor, or breastfeeding mothers\n  * Individuals deprived of liberty by judicial or administrative decision\n  * Individuals undergoing psychiatric treatment under Article L.3213-1 of the French Public Health Code","25 Years","65 Years",{"count":379,"type":22},40,"The goal of this observational study is to evaluate the acceptability ofpatients with trisomy 21 (T21) to perform the full battery of ENDI neurospychological tests and each of the subsets.\n\nIn this study, three types of population will be recruted : normotypic volunteers, patients with Intellectual Disability and patients T21carriers.\n\nThis study is separated into 2 phases :\n\n* A the preliminary phase : this phase will be used to evaluate subtest design, ergonomics and understanding of instructions, and to identify any malfunctions. The observations gathered will enable the principal investigator to refine the digital design of the battery in collaboration with the publishing company. In this phase, normotypical volunteers and patients with intellectual disabilities will be recruted to perform ENDI test battery.\n* A main phase : this phase will enable to answer to the main objective. in this phase, patients with Trisomy 21 aged between 25 and 65 will be recruted to perform ENDI test battery.",[29,382,383,136,384],"Neuropsychology","Cognitive Aging","Alzheimer Disease, Early Onset",[29,374,105,386,387],"neuropsychology","ENDI tests battery","2025-06-24",{"date":390,"type":41},"2025-07-02",{"date":392,"type":22},"2025-07-01",{"date":394,"type":22},"2026-11-01",{"name":396,"class":48},"Central Hospital, Nancy, France"]