Official Title: “Multi-Center, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease”

The purpose of this study is to verify the progression delaying effect of escitalopram in Alzheimer's disease using volumetric MRI change as a primary outcome measure.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2010

- Study institutions: Four university hospitals in Korea - Design:52 week, randomized, placebo-controlled, double-blind, parallel group design - Subjects:80 probable Alzheimer's disease patients who have been taking donepezil at stable dose for at least 2 months (Escitalopram 40 : Placebo 40)

Intervention(s) in this Clinical Trial

• Drug: escitalopram
  • 5mg/day for 2weeks, 10mg/day for 2weeks and 20mg/day for 48weeks (maintaining donepezil at the previous stable dose during the whole trial period)
• Drug: placebo
  • 5mg/day for 2weeks, 10mg/day for 2weeks and 20mg/day for 48weeks (maintaining donepezil at the previous stable dose during the whole trial period)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • escitalopram 20mg
• Placebo Comparator: 2
  • Placebo

Primary Measures

• % change of hippocampal and whole brain volume
  • Time Frame: 52 weeks
    Safety Issue?: No

Secondary Measures

• Cognition: ADAD-cog (Alzheimer's Disease Assessment Scale-cognitive subscale), MMSE (Mini-Mental State Examination) Neuropsychiatric symptoms: NPI (Neuropsychiatric Inventory), CSDD (Cornell Scale for Depression in Dementia)
  • Time Frame: 52 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Seoul National University Hospital

Overall Clinical Trial Officials and Contacts

Dong Young Lee, MD, PhD Principal Investigator Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine  

Overall Contact: Dong Young Lee, MD, PhD 82-2-2072-2205 selfpsy@snu.ac.kr

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00702780

Study ID Number: SNUDC001

ClinicalTrials.gov Identifier: NCT00702780

Health Authority: Korea: Food and Drug Administration