[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100386489":3},{"organization":4,"armGroups":7,"interventions":49,"overallOfficials":56,"centralContacts":60,"locations":66,"responsibleParty":83,"collaborators":55,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":55,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":55,"overallStatus":69,"whyStopped":55,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,13,17,21,25,29,33,37,41,45],{"label":9,"type":6,"description":10,"interventionNames":11},"oral hormonal therapy","Postmenopausal women who start with oral hormonal therapy (Progesteron + uterogestan) according to standard of care practice. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],"Procedure: blood take",{"label":14,"type":6,"description":15,"interventionNames":16},"transdermal hormonal therapy","Postmenopausal women who start with transdermal hormonal (Oestrogel + uterogestan) therapy according to standard of care practice. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"oral hormonal therapy + hysterectomy","Postmenopausal women who start with oral hormonal therapy (progesteron) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":22,"type":6,"description":23,"interventionNames":24},"transdermal hormonal therapy + hysterectomy","Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and had a hysterectomy in the past. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":26,"type":6,"description":27,"interventionNames":28},"oral hormonal therapy + IUD","Postmenopausal women who start with oral hormonal therapy (Progynova) according to standard of care practice and have already an intra-uterine device. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":30,"type":6,"description":31,"interventionNames":32},"transdermal hormonal therapy + IUD","Postmenopausal women who start with transdermal hormonal therapy (Oestrogel ) according to standard of care practice and have an intra-uterine device. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":34,"type":6,"description":35,"interventionNames":36},"selective oestrogenreceptor modulators","Postmenopausal women who start with hormonal therapy according to standard of care practice and take selective oestrogenreceptor modulators (Nolvadex) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":38,"type":6,"description":39,"interventionNames":40},"aromatase inhibitors","Postmenopausal women who start with hormonal therapy according to standard of care practice and who taken aromatase inhibitors (Femara) because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":42,"type":6,"description":43,"interventionNames":44},"Duavive","Postmenopausal women who start with hormonal therapy according to standard of care practice and who take duavive because of their cancer in their medical history. Before the start of the treatment blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],{"label":46,"type":6,"description":47,"interventionNames":48},"Control","Postmenopausal women who don't start with hormonal therapy according to standard of care practice. At the first study visit blood will be taken and 6 (and 12) months after the start of the therapy blood will be taken for analysis. At the 2\u002F3 study visits the patient will be asked to complete the questionaires (TANGO-SF, ICIQ, Cohen, Pittsburgh sleep quality). Only at the first study visit an MMSE test will be taken, to make sure the patient has no dementia.",[12],[50],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"PROCEDURE","blood take","Blood is taken to analyse degradation products of the metabolism of amyloid",[46,42,38,9,26,18,34,14,30,22],null,[57],{"name":58,"affiliation":5,"role":59},"Herman Depypere, MD","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":55,"email":65},"Eline Meireson, Msc","CONTACT","0032 9 332 78 17","eline.meireson@uzgent.be",[67],{"facility":68,"status":69,"city":70,"state":55,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"Ghent university hospital","RECRUITING","Ghent","9000","Belgium","BE",{"type":75,"coordinates":76},"Point",[77,78],3.71667,51.05,{"lat":78,"lon":77},[81,82],{"name":62,"role":63,"phone":64,"phoneExt":55,"email":65},{"name":58,"role":59,"phone":55,"phoneExt":55,"email":55},{"type":84,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","100386489","hormone-replacement-trial-against-alzheimers-disease-100386489",false,"NCT04312399","Hormone Replacement Trial Against ALzheimers' Disease","HARALD","Inclusion Criteria:\n\n* postmenopausal women\n* 40 - 65 years\n\nExclusion Criteria:\n\n* Longer than 10 years in menopause\n* thyroid dysfunction\n* hypertension\n* medical history of psychiatric comorbidity\n* Alcohol and\u002For drug abuse\n* medical history of neurologic symptoms with cognitive symptoms",true,"FEMALE","40 Years","65 Years",{"count":97,"type":98},600,"ESTIMATED","INTERVENTIONAL",[101],"NA","The influence of postmenopausal hormone treatment on dementia is not clear. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid.\n\nThe degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy.\n\nPostmenopausal women with and without history of breast cancer will be recruited for the trial.",[104,105],"Postmenopausal Symptoms","Alzheimer Disease","2025-01-22",{"date":108,"type":109},"2025-01-27","ACTUAL",{"date":111,"type":109},"2018-04-17",{"date":113,"type":98},"2028-12-31",{"name":5,"class":6},1]