[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100413261":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":27,"locations":36,"responsibleParty":52,"collaborators":54,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":12,"enrollmentInfo":67,"targetDuration":12,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":39,"whyStopped":12,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive remediation","NO_INTERVENTION","Non-drug treatment, cognitive remediation, cognitive stimulation",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Cognitive remediation + Donepezil","EXPERIMENTAL","Non-drug treatment, cognitive remediation, cognitive stimulation + Donepezil",[18],"Drug: Donepezil",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Donepezil","Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.",[14],[26],"Aricept",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},"DUMURGIER Julien, MD, PhD","CONTACT","+33140054313","julien.dumurgier@aphp.fr",{"name":34,"role":30,"phone":12,"phoneExt":12,"email":35},"PAQUET Claire, MD, PhD","claire.paquet@inserm.fr",[37],{"facility":38,"status":39,"city":40,"state":12,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Cognitive Neurology Center","RECRUITING","Paris","75010","France","FR",{"type":45,"coordinates":46},"Point",[47,48],2.3488,48.85341,{"lat":48,"lon":47},[51],{"name":29,"role":30,"phone":31,"phoneExt":12,"email":32},{"type":53,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[55],{"name":56,"class":6},"France Alzheimer","100413261","phase-3-donepezil-versus-non-drug-treatment-in-alzheimers-disease-100413261",false,"NCT04661280","Donepezil Versus Non-drug Treatment in Alzheimer's Disease.","Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study","CHOLINE-2","Inclusion Criteria:\n\n* Diagnosis of Alzheimer's disease according to the IWG-2 criteria.\n* Age ≥ 50 years.\n* Absence of legal protection measures (guardianship, curatorship).\n* MMSE score ≥ 10 at inclusion.\n* abnormal values for Aβ42 in the CSF or Aβ40 \u002F Aβ42 ratio.\n* abnormal values for phosphorylated Tau in CSF\n* Presence of a family carer or a person at home who can ensure compliance with treatment if MMSE score \\\u003C20.\n* French native speaker.\n\nExclusion Criteria:\n\n* Other cause of dementia.\n* Previous use of symptomatic treatment for Alzheimer's disease.\n* Hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the SPC.\n* Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, sinus disease or other supra-ventricular conduction abnormalities such as sinoatrial or atrioventricular block.\n* Taking concomitant medications known to prolong the interval QTc\n* Patients at particular risk of ulcer, known ulcer disease or receiving concomitant treatment with non-steroidal anti-inflammatory drugs.\n* Patient at risk of urinary retention.\n* History of epileptic disease.\n* History of neuroleptic malignant syndrome.\n* History of asthma or obstructive bronchopulmonary disease.\n* Severe hepatic impairment.\n* Taking one of the following treatments:\n\n  * CYP3A4 inhibitors, such as ketonazole.\n  * 2D6 inhibitors, such as quinidine.\n  * CYP3A4 inhibitors, such as itraconazole and erythromycin.\n  * CYP2D6 inhibitors, such as fluoxetine.\n  * Enzyme inducers such as rifampicin, phenytoin, carbamazepine.\n  * Antiarrhythmic class IA agents\n  * Antiarrhythmic class III agents\n  * other Antipsychotics such as phenothiazine, sertindole, pimozide, ziprasidone.\n  * some antiobiotics such as clarithromycine, erythromycine, levofloxacine, moxifloxacine.\n* Participation in another interventional study.","ALL","50 Years",{"count":68,"type":69},240,"ESTIMATED","INTERVENTIONAL",[72],"PHASE3","Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more reimbursed by the French healthcare system, due to a controversy about its efficiency. French health authorities currently preconize a non-rug approach based on cognitive remediation or stimulation.\n\nThe aim of this study is to compare the efficiency of the 2 approaches (non-drug versus donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.",[75],"Alzheimer Disease, Early Onset",[77,22],"Alzheimer Disease","2026-02-16",{"date":80,"type":81},"2026-02-18","ACTUAL",{"date":83,"type":81},"2022-02-10",{"date":85,"type":69},"2026-08",{"name":5,"class":6},1]