{"protocolSection":{"identificationModule":{"nctId":"NCT00702780","orgStudyIdInfo":{"id":"SNUDC001"},"organization":{"fullName":"Seoul National University Hospital","class":"OTHER"},"briefTitle":"Progression Delaying Effect of Escitalopram in Alzheimer's Disease","officialTitle":"Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease","acronym":"ESAD"},"statusModule":{"statusVerifiedDate":"2014-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2008-11"},"primaryCompletionDateStruct":{"date":"2011-09","type":"ACTUAL"},"completionDateStruct":{"date":"2011-09","type":"ACTUAL"},"studyFirstSubmitDate":"2008-06-15","studyFirstSubmitQcDate":"2008-06-18","studyFirstPostDateStruct":{"date":"2008-06-20","type":"ESTIMATED"},"resultsFirstSubmitDate":"2014-04-10","resultsFirstSubmitQcDate":"2014-05-13","resultsFirstPostDateStruct":{"date":"2014-06-13","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-05-13","lastUpdatePostDateStruct":{"date":"2014-06-13","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Dong Young Lee","investigatorTitle":"Professor","investigatorAffiliation":"Seoul National University Hospital"},"leadSponsor":{"name":"Seoul National University Hospital","class":"OTHER"},"collaborators":[{"name":"H. Lundbeck A/S","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.","detailedDescription":"* Study institutions: Four university hospitals in Korea\n* Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial\n* Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)"},"conditionsModule":{"conditions":["Alzheimer's Disease"],"keywords":["Alzheimer's disease","escitalopram","MRI"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":74,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Escitalopram","type":"EXPERIMENTAL","description":"Escitalopram 20mg tablet by mouth once a day","interventionNames":["Drug: escitalopram"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Placebo 20mg tablet by mouth once a day","interventionNames":["Drug: placebo"]}],"interventions":[{"type":"DRUG","name":"escitalopram","description":"5 mg/day for 2 weeks, 10 mg/day for 2 weeks and 20 mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)","armGroupLabels":["Escitalopram"],"otherNames":["Lexapro"]},{"type":"DRUG","name":"placebo","description":"5mg/day for 2 weeks, 10mg/day for 2 weeks and 20mg/day for 48 weeks (maintaining donepezil at the previous stable dose during the whole trial period)","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"% Change of Hippocampus Volume","timeFrame":"52 weeks"},{"measure":"% Change of Whole Brain Volume","timeFrame":"52 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Age:40\\~90 years\n* Education:not illiterate\n* Clinical Dementia Rating (CDR):0.5\\~2\n* Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4\n* Dementia according to DSM-IV criteria\n* Probable Alzheimer's disease according to NINCDS-ADRDA criteria\n* Current ongoing donepezil medication at stable doses (5 \\~ 10 mg/day) for at least 2 months\n\nExclusion criteria:\n\n* Evidence of delirium, confusion or altered consciousness\n* Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus\n* Evidence of infectious or inflammatory brain disease\n* Evidence of serious cerebrovascular diseases\n* Current major depressive disorder or other major psychiatric illnesses\n* Evidence of serious or unstable medical illnesses which can significantly change cognitive state\n* History of alcohol or other substance dependence\n* Any antidepressant medications within the previous 4 weeks\n* Absence of a reliable and cooperative collateral informant\n* Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia\n* Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale","healthyVolunteers":false,"sex":"ALL","minimumAge":"40 Years","maximumAge":"90 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Dong Young Lee, MD, PhD","affiliation":"Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine","role":"PRINCIPAL_INVESTIGATOR"},{"name":"Jong Inn Woo, MD, PhD","affiliation":"Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Kangwon National University Hospital","city":"Chuncheon","country":"South Korea","geoPoint":{"lat":37.87472,"lon":127.73417}},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam","country":"South Korea","geoPoint":{"lat":35.48474,"lon":129.30505}},{"facility":"Seoul National University Hospital","city":"Seoul","zip":"110-744","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}},{"facility":"Konkuk University Hospital","city":"Seoul","country":"South Korea","geoPoint":{"lat":37.566,"lon":126.9784}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Escitalopram","description":"escitalopram 20mg qd"},{"id":"FG001","title":"Placebo","description":"placebo 20mg qd"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"37"},{"groupId":"FG001","numSubjects":"37"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"28"},{"groupId":"FG001","numSubjects":"29"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"8"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Escitalopram","description":"escitalopram 20mg qd"},{"id":"BG001","title":"Placebo","description":"placebo 20mg qd"},{"id":"BG002","title":"Total","description":"Total of all reporting 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":37},{"groupId":"EG001","numAffected":1,"numAtRisk":37}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":37},{"groupId":"EG001","numAffected":1,"numAtRisk":37}]}],"otherEvents":[{"term":"dizziness","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":37},{"groupId":"EG001","numAffected":0,"numAtRisk":37}]},{"term":"vomiting","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":37},{"groupId":"EG001","numAffected":1,"numAtRisk":37}]},{"term":"anorexia","organSystem":"Gastrointestinal 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complications","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":37},{"groupId":"EG001","numAffected":1,"numAtRisk":37}]},{"term":"violent behavior","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37},{"groupId":"EG001","numAffected":0,"numAtRisk":37}]},{"term":"urinary incontinence","organSystem":"Renal and urinary disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37},{"groupId":"EG001","numAffected":0,"numAtRisk":37}]},{"term":"hypoglycemia","organSystem":"Endocrine disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37},{"groupId":"EG001","numAffected":0,"numAtRisk":37}]},{"term":"cancer","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":37},{"groupId":"EG001","numAffected":1,"numAtRisk":37}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Young Min Choe","organization":"Seoul National University Hospital","email":"howlow44@daum.net","phone":"82-2-2072-1730"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D000544","term":"Alzheimer Disease"}],"ancestors":[{"id":"D003704","term":"Dementia"},{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D024801","term":"Tauopathies"},{"id":"D019636","term":"Neurodegenerative Diseases"},{"id":"D019965","term":"Neurocognitive Disorders"},{"id":"D001523","term":"Mental 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