[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489161":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":41,"centralContacts":45,"locations":51,"responsibleParty":69,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":24,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":54,"whyStopped":24,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","Prodromal Alzheimer's patients",[13,14,15,16,17],"Procedure: Polysomnography","Behavioral: Neuropsychological assessment","Behavioral: Questionnaires on sleep and behavioural problems","Procedure: Actimetrics","Other: Biomarker assay",[19,25,30,33,37],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Polysomnography","Polysomnography will be performed for 24 hours at inclusion and 24 months",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"BEHAVIORAL","Neuropsychological assessment","A full neuropsychological assessment will be performed at inclusion, 12 and 24 months",[9],{"type":26,"name":31,"description":31,"armGroupLabels":32,"otherNames":24},"Questionnaires on sleep and behavioural problems",[9],{"type":20,"name":34,"description":35,"armGroupLabels":36,"otherNames":24},"Actimetrics","Measurement of actimetrics for 14 days at inclusion and at 24 months",[9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":24},"Biomarker assay","Determination of the biomarkers Aβ42, Aβ40, Tau and P-Tau in blood and in the cerebrospinal fluid",[9],[42],{"name":43,"affiliation":5,"role":44},"Karim BENNYS, MD","PRINCIPAL_INVESTIGATOR",[46],{"name":47,"role":48,"phone":49,"phoneExt":24,"email":50},"Yves Dauvilliers, MD","CONTACT","+33467335219","y-dauvilliers@chu-montpellier.fr",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"CHU de Montpellier","RECRUITING","Montpellier","Hérault","34000","France","FR",{"type":61,"coordinates":62},"Point",[63,64],3.87635,43.61093,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":24,"phoneExt":24,"email":24},"Yves DAUVILLIERS",{"type":70,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[72],{"name":73,"class":74},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV","100489161","sleep-impairment-in-subjects-at-risk-of-developing-alzheimers-disease-100489161",false,"NCT05649514","Sleep Impairment in Subjects at Risk of Developing Alzheimer's Disease","Objective Sleep Impairment in APOEε4\u002Fε4 Subjects at Risk of Developing Alzheimer's Disease: Risk Factor for Cognitive Decline?","WAVE-APOE4","Inclusion Criteria:\n\n* Diagnosis of mild Alzheimer's disease with a MMS between 21-30\n* Without anticholinesterase and\u002For memantine treatment or on stable doses for at least 3 months\n* No antidepressant or anxiolytic treatment or stopped for at least 15 days\n* The presence of a family carer to complete neuropsychological scales, questionnaires and sleep diaries\n* Signed informed consent\n* Able to carry out all visits and follow study procedures\n* Affiliation to the French social security system\n\nExclusion Criteria:\n\n* Genetic form of alzheimer's disease\n* Insufficient clinical and paraclinical information for the diagnosis of AD\n* Patient living in a nursing home\n* Illiteracy or inability to perform psycho-behavioural tests\n* Major physical or neurosensory problems that may interfere with the tests\n* Patient deprived of liberty, by judicial or administrative decision;\n* Major depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)\n* Major protected by law;\n* Short-term life-threatening conditions","ALL","50 Years","85 Years",{"count":87,"type":88},50,"ESTIMATED","INTERVENTIONAL",[91],"NA","Alzheimer's disease (AD) is characterised by a progressive loss of memory and cognitive function. In the early stages of AD, there is a progressive accumulation of molecules: β-amyloid peptides (Aβ) in the brain. There is a link between the accumulation of Aβ peptides and the deterioration of sleep, but current knowledge does not confirmed this link. The objective of this study is to define whether there is a link between cognitive decline and sleep disorders. If a correlation is found, this could allow earlier treatment of sleep disorders in the longer term in order to slow the development of AD.\n\nTreatment protocols in the field of Alzheimer's disease (AD) are directed towards participants at risk of developing the disease, such as those who carry at least one ε4 allele on apolipoprotein E (APOE ε4). An individual with 2 ε4 copies has a 30-55% risk of developing AD with an age of onset around 68 years and a dose effect of the allele on risk and age of onset of symptoms.",[94,95,96],"Neuropathology","Cognitive Decline","Sleep Disorder",[98,99,100,101],"cognitive composite score","sleep","biomarkers","cognitive decline","2025-06-23",{"date":104,"type":105},"2025-06-27","ACTUAL",{"date":107,"type":105},"2025-02-05",{"date":109,"type":88},"2027-12-01",{"name":5,"class":6},1]