Progression Delaying Effect of Escitalopram in Alzheimer's Disease (ESAD)

May 13, 2014 updated by: Dong Young Lee, Seoul National University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Chuncheon, Korea, Republic of
        • Kangwon National University Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Konkuk University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Escitalopram
Escitalopram 20mg tablet by mouth once a day
Drug: 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)
Other Names:
  • Lexapro
Placebo Comparator: Placebo
Placebo 20mg tablet by mouth once a day
Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
% Change of Hippocampus Volume
Time Frame: 52 weeks
52 weeks
% Change of Whole Brain Volume
Time Frame: 52 weeks
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

H. Lundbeck A/S

Investigators

  • Principal Investigator: Dong Young Lee, MD, PhD, Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
  • Principal Investigator: Jong Inn Woo, MD, PhD, Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 15, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUDC001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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