[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596630":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":10,"centralContacts":30,"locations":36,"responsibleParty":54,"collaborators":10,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":29,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":83,"whyStopped":10,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Central Hospital, Nancy, France","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Trisomy 21 patients",null,"Trisomy 21 patients recruted on Main Phase will perform the ENDI tests in order to assess the acceptability of the subtests (individually) and the full neuropsychological battery",[13],"Diagnostic Test: ENDI (Neuropsychological Evaluation in Intellectual Disability)",{"label":15,"type":10,"description":16,"interventionNames":17},"Patients with Intellectual Disabilities","Patients with Intellectual Disabilities recruted on Preliminary Phase will be will carry out the ENDI tests in order to evaluate subtest design, ergonomics, understanding of instructions and 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.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Normotypical volunteers","Normotypical volunteers recruted on Preliminary Phase will be will carry out the ENDI tests in order to evaluate subtest design, ergonomics, understanding of instructions and 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.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DIAGNOSTIC_TEST","ENDI (Neuropsychological Evaluation in Intellectual Disability)","This neuropsychological battery comprises 15 subtests designed to assess language, memory, attention and executive skills. By analyzing changes in Trisomy 21 patients performance over time, the neuropsychologist can detect early signs of Alzheimer's disease.",[19,15,9],[29],"ENDI",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Amélie COQUELET, Psychologist","CONTACT","+33 3 83 15 79 64","a.coquelet@chru-nancy.fr",[37],{"facility":38,"status":10,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"CHRU de Nancy","Vandœuvre-lès-Nancy","Grand Est","54511","France","FR",{"type":45,"coordinates":46},"Point",[47,48],6.17114,48.66115,{"lat":48,"lon":47},[51,52],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},{"name":32,"role":53,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":53,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"COQUELET Amelie","Principal Investigator","100596630","neuropsychological-evaluation-in-intellectual-disability-endi-100596630",false,"NCT07047963","Neuropsychological Evaluation in Intellectual Disability (ENDI)","Neuropsychological Evaluation in Intellectual Disability","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",true,"ALL","25 Years","65 Years",{"count":69,"type":70},40,"ESTIMATED","OBSERVATIONAL","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.",[74,75,76,77,78],"Down Syndrome (Trisomy 21)","Neuropsychology","Cognitive Aging","Alzheimer Disease","Alzheimer Disease, Early Onset",[74,29,80,81,82],"Trisomy 21","neuropsychology","ENDI tests battery","NOT_YET_RECRUITING","2025-06-24",{"date":86,"type":87},"2025-07-02","ACTUAL",{"date":89,"type":70},"2025-07-01",{"date":91,"type":70},"2026-11-01",{"name":5,"class":6},1]