Progression Delaying Effect of Escitalopram in Alzheimer's Disease
NCT ID: NCT00702780
Last Updated: 2014-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
74 participants
INTERVENTIONAL
2008-11-30
2011-09-30
Brief Summary
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Detailed Description
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* Design: Multi-center, randomized, placebo-controlled, double-blind clinical trial
* Subjects: 74 probable Alzheimer's disease patients who have been taking donepezil at stable dose within 2 months (Escitalopram 37 : Placebo 37)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Escitalopram
Escitalopram 20mg tablet by mouth once a day
escitalopram
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)
Placebo
Placebo 20mg tablet by mouth once a day
placebo
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)
Interventions
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escitalopram
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)
placebo
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Education:not illiterate
* Clinical Dementia Rating (CDR):0.5\~2
* Modified Hachinski Ischemic Score (Rosen et al., 1979):less than 4
* Dementia according to DSM-IV criteria
* Probable Alzheimer's disease according to NINCDS-ADRDA criteria
* Current ongoing donepezil medication at stable doses (5 \~ 10 mg/day) for at least 2 months
Exclusion Criteria
* Evidence of Parkinson's disease, stroke, brain tumor and normal pressure hydrocephalus
* Evidence of infectious or inflammatory brain disease
* Evidence of serious cerebrovascular diseases
* Current major depressive disorder or other major psychiatric illnesses
* Evidence of serious or unstable medical illnesses which can significantly change cognitive state
* History of alcohol or other substance dependence
* Any antidepressant medications within the previous 4 weeks
* Absence of a reliable and cooperative collateral informant
* Any conditions which prohibit MRI scan, such as presence of pacemaker or cerebrovascular clip, and claustrophobia
* Evidence of focal brain lesions on MRI including lacunes and white matter hyperintensity lesions of grade 2 or more by Fazeka scale
40 Years
90 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Dong Young Lee
Professor
Principal Investigators
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Dong Young Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Jong Inn Woo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Locations
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Kangwon National University Hospital
Chuncheon, , South Korea
Seoul National University Bundang Hospital
Seongnam, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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SNUDC001
Identifier Type: -
Identifier Source: org_study_id
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