[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510283":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":62,"centralContacts":66,"locations":71,"responsibleParty":92,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":31,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":73,"whyStopped":31,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Daridorexant 50 mg","EXPERIMENTAL","Patients will receive daridorexant 50 mg during one month (Period A or Period B).\n\nDaridorexant is an orally administered dual orexin type 1 and type 2 (OX1 and OX2) receptor antagonist (DORA) being developed for the treatment of insomnia.",[13,14,15,16,17,18,19],"Drug: Daridorexant 50 mg","Procedure: Polysomnography","Behavioral: Neuropsychological assessment","Behavioral: Questionnaires on sleep and behavioural problems","Procedure: Actimetrics","Procedure: 24-hour Ambulatory Blood Pressure Monitoring (ABPM","Other: Biomarker assay",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo-controlled arm","PLACEBO_COMPARATOR","Patients will receive a placebo matching to daridorexant 50 mg during one month (Period A or Period B).",[25,14,15,16,17,18,19],"Drug: Placebo",[27,32,36,41,46,50,54,58],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Patients randomized in the experimental group will receive the treatment every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.",[9],null,{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Placebo","Patients randomized in the control group will receive the placebo every evening within 30 minutes of going to bed during one month. The treatment period (Period A or Period B) will be followed by a one-week (range 5-12 days) washout period at home.",[21],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"PROCEDURE","Polysomnography","A full-night polysomnography recording with blood pressure and heart rate monitoring will be performed at night in the Sleep Laboratory from 11 p.m. to 7 a.m. at baseline (before the randomization) and at the end of each period (Period A\u002FM1, Period B\u002FM2). The recording procedure consists of an electroencephalogram, two electrooculograms, an electromyogram, an electrocardiogram, and a videographic recording. This examination is painless (the sensors are glued to the skin for the duration of the recording). The advantages of this video-polysomnography are based on the evaluation of sleep architecture, micro-arousals, respiratory events and nocturnal motor behavior.",[9,21],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":31},"BEHAVIORAL","Neuropsychological assessment","A full neuropsychological assessment will be performed at inclusion, M1, M2",[9,21],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":31},"Questionnaires on sleep and behavioural problems","Questionnaires on sleep and behavioural problems will be performed at inclusion, M1, M2",[9,21],{"type":37,"name":51,"description":52,"armGroupLabels":53,"otherNames":31},"Actimetrics","Measurement of actimetrics for seven days in average (with a minimum of three nights required) prior to the inclusion visit, M1 visit and M2 visit.",[9,21],{"type":37,"name":55,"description":56,"armGroupLabels":57,"otherNames":31},"24-hour Ambulatory Blood Pressure Monitoring (ABPM","Evaluation of the 24-hour hemodynamic profile of a patient by multiple and regular blood pressure and heart rate measurements. The ABP will be monitored at inclusion, M1 and M2",[9,21],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":31},"Biomarker assay","Determination of AD biomarkers (Aβ42, Aβ40, Tau, P-Tau, neurofilament) and proinflammatory cytokines (TNFa, IL6) in serum and cerebrospinal fluid (CSF) and dosage of Orexin-A\u002Fhypocretin-1 in the CSF",[9,21],[63],{"name":64,"affiliation":5,"role":65},"Yves Dauvilliers, MD","PRINCIPAL_INVESTIGATOR",[67],{"name":64,"role":68,"phone":69,"phoneExt":31,"email":70},"CONTACT","+33467336361","y-dauvilliers@chu-montpellier.fr",[72],{"facility":5,"status":73,"city":74,"state":31,"zip":31,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Montpellier","France","FR",{"type":78,"coordinates":79},"Point",[80,81],3.87635,43.61093,{"lat":81,"lon":80},[84,86,87,90],{"name":85,"role":68,"phone":69,"phoneExt":31,"email":70},"Yves DAUVILLIERS, MD",{"name":85,"role":65,"phone":31,"phoneExt":31,"email":31},{"name":88,"role":89,"phone":31,"phoneExt":31,"email":31},"Lucie BARATEAU, MD","SUB_INVESTIGATOR",{"name":91,"role":89,"phone":31,"phoneExt":31,"email":31},"Karim BENNYS, MD",{"type":93,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[95],{"name":96,"class":97},"Idorsia Pharmaceuticals Ltd.","INDUSTRY","100510283","phase-4-daridorexant-to-treat-insomnia-in-patients-with-mild-cognitive-impairment-and-mild-to-moderate-alzheimer-disease-100510283",false,"NCT05924425","Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease","DARIDOR-ALZ","Inclusion criteria :\n\n* Age \\[60-85\\] years old\n* Outpatients\n* Pre-screening:\n\n  * Complaints of dissatisfaction with sleep quantity or quality, despite adequate opportunity for sleep, at least 3 nights per week and for at least 3 months, and\n  * Total sleep time causes clinically significant distress or impairment in daytime functioning, and\n  * Total sleep time estimated by interview was below 6 hours, on at least 3 nights per week and for at least 1 month before screening\n* Baseline PSG (at randomization) assessed TST \\\u003C 6 hours and WASO \\> 1 hour\n* Diagnosis of MCI and AD patients at an early stage according to the NIA diagnosis criteria (core clinical criteria for MCI, positive CSF Aβ42 and\u002For positive plasma biomarker, and neuronal injury (hippocampal and\u002For temporal atrophy by MRI))\n* MMSE from 12 to 26\n* Clinical Dementia Rating CDR from 0.5 to 2\n* Use of CNS-active medications is permitted provided the dose has been stable for at least 3 months, including: anticholinesterase drugs (rivastigmine, donepezil, galantamine) or memantine, antidepressants SSRI (e.g. fluoxetine, sertraline, paroxetine…), SNRI (e.g. venlafaxine, duloxetine), neuroleptics (e.g. clozapine, olanzapine, aripiprazole...) or drug for pain level 2 (codeine, tramadol).\n* For a male subject who is not sterilized and is sexually active with a female partner of childbearing potential, no contraceptive methods are needed\n\nNon inclusion criteria :\n\n* Patients significantly dependent on caregivers\n* Institutionalized patients\n* Analphabetism or subjects unable to read or\u002Fand write\n* Patients unable to perform the neuropsychological tests\n* Patients unable to complete the study instruments (sleep diary)\n* Planned longer stay outside the region that prevents compliance with the visit schedule\n* Patients who cannot be followed up for at least 2 months\n* History of narcolepsy and\u002For cataplexy\n* History of drug or alcohol abuse or addiction\n* History of diagnosed and characterized psychiatric disorders (DSM-5), cured or stabilized (with or without the same treatment for at least 3 months) and excluding any current characterized psychiatric disorder (DSM-5), the diagnosis of which is established by a psychiatrist trained in geriatric psychiatry\n* Moderate and severe liver failure\n* PSG baseline evidence of significant\u002Fsevere sleep-related breathing disorder (defined as \\>30 apnea\u002Fhypopnea episodes per hour)\n* Treatments interfering with sleep-wake patterns\n* Use of hypnotics (benzodiazepines, zolpidem, zopiclone) or drug for pain level 3 (morphine and derivatives)\n* Hypersensitivity to the active substance or to any of the excipients listed in the Summary of Product Characteristics (SmPC)\n* Forbidden and restricted concomitant medications:\n\n  * Concomitant CNS-depressant medicinal products\n  * CYP3A4 inhibitors\n  * CYP3A4 inducers\n* Participation in another clinical trial or administration of an investigational product\n* Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship\u002Fcuratorship).\n* Subjects not covered by public health insurance\n* Failure to obtain written informed consent after a reflection period","ALL","60 Years","85 Years",{"count":109,"type":110},62,"ESTIMATED","INTERVENTIONAL",[113],"PHASE4","DARIDOR-ALZ is a phase IV clinical trial designed to evaluate both the efficacy and safety of daridorexant, a selective dual orexin receptor antagonist that blocks the actions of the orexin neuropeptides at both orexin-1 and orexin-2 receptors, in selected populations of MCI and mild-to-moderate AD patients with insomnia complaints.",[116,117,118],"Alzheimer Disease","Insomnia Disorder","Sleep",[120,121,122,123,118,124],"Orexin","Daridorexant","Cognition","Alzheimer","Insomnia","2026-06-24",{"date":127,"type":128},"2026-06-25","ACTUAL",{"date":130,"type":128},"2024-03-13",{"date":132,"type":110},"2028-03-13",{"name":5,"class":6},1]