Progression Delaying Effect of Escitalopram in Alzheimer's Disease

Not Applicable

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: placebo; Drug: escitalopram

• Registration Number: NCT00702780
• Lead Sponsor: Seoul National University Hospital

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)

Study Timeline

• Study First Submitted: 2008-06-15
• Study First Submitted QC: 2008-06-18
• Study First Posted: 2008-06-20
• Study Start: 2008-11
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Results First Submitted: 2014-04-10
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-13
• Last Update Submitted: 2014-05-13
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo 20mg tablet by mouth once a day
Escitalopram	escitalopram	Escitalopram 20mg tablet by mouth once a day

Primary Outcome Measures

Name	Time	Method
% Change of Whole Brain Volume	52 weeks
% Change of Hippocampus Volume	52 weeks

Trial Locations

Locations (4)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of