search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
escitalopram
placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, escitalopram, MRI

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kangwon National University Hospital
  • Seoul National University Bundang Hospital
  • Seoul National University Hospital
  • Konkuk University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Escitalopram

Placebo

Arm Description

Escitalopram 20mg tablet by mouth once a day

Placebo 20mg tablet by mouth once a day

Outcomes

Primary Outcome Measures

% Change of Hippocampus Volume
% Change of Whole Brain Volume

Secondary Outcome Measures

Full Information

First Posted
June 15, 2008
Last Updated
May 13, 2014
Sponsor
Seoul National University Hospital
Collaborators
H. Lundbeck A/S
search

1. Study Identification

Unique Protocol Identification Number
NCT00702780
Brief Title
Progression Delaying Effect of Escitalopram in Alzheimer's Disease
Acronym
ESAD
Official Title
Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, escitalopram, MRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram 20mg tablet by mouth once a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 20mg tablet by mouth once a day
Intervention Type
Drug
Intervention Name(s)
escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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)
Primary Outcome Measure Information:
Title
% Change of Hippocampus Volume
Time Frame
52 weeks
Title
% Change of Whole Brain Volume
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Young Lee, MD, PhD
Organizational Affiliation
Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Inn Woo, MD, PhD
Organizational Affiliation
Dept. of Neuropsychiatry, Seoul National University Hospital & Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Progression Delaying Effect of Escitalopram in Alzheimer's Disease

We'll reach out to this number within 24 hrs