NCT00702780
Completed
Not Applicable
Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
Overview
- Phase
- Not Applicable
- Intervention
- escitalopram
- Conditions
- Alzheimer's Disease
- Sponsor
- Seoul National University Hospital
- Enrollment
- 74
- Locations
- 4
- Primary Endpoint
- % Change of Whole Brain Volume
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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
* 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)
Investigators
Dong Young Lee
Professor
Seoul National University Hospital
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Arms & Interventions
Escitalopram
Escitalopram 20mg tablet by mouth once a day
Intervention: escitalopram
Placebo
Placebo 20mg tablet by mouth once a day
Intervention: placebo
Outcomes
Primary Outcomes
% Change of Whole Brain Volume
Time Frame: 52 weeks
% Change of Hippocampus Volume
Time Frame: 52 weeks
Study Sites (4)
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