Progression Delaying Effect of Escitalopram in Alzheimer's Disease

Study Overview
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Brief Summary
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This study aimed to test whether escitalopram would slow the brain atrophy in patients with mild to moderate AD over the 52-week period.

Detailed Description
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Study institutions: Four university hospitals in Korea 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)

Official Title
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Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: escitalopram
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age:40 90 years 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 delirium, confusion or altered consciousness 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>Escitalopram 20mg tablet by mouth once a day | Drug: escitalopram<br>* 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)<br>* Other names: Lexapro;|
| Placebo Comparator: Placebo<br>Placebo 20mg tablet by mouth once a day | Drug: placebo<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Change of Hippocampus Volume |  | 52 weeks | 
| % Change of Whole Brain Volume |  | 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, escitalopram, MRI