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

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ClinicalTrials.gov Identifier: NCT00702780
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Dong Young Lee, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE June 15, 2008
First Posted Date  ICMJE June 20, 2008
Results First Submitted Date  ICMJE April 10, 2014
Results First Posted Date  ICMJE June 13, 2014
Last Update Posted Date June 13, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • % Change of Hippocampus Volume [ Time Frame: 52 weeks ]
  • % Change of Whole Brain Volume [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
% change of hippocampal and whole brain volume [ Time Frame: 52 weeks ]
Change History Complete list of historical versions of study NCT00702780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Progression Delaying Effect of Escitalopram in Alzheimer's Disease
Official Title  ICMJE Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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 Name: Lexapro
  • 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)
Study Arms  ICMJE
  • Experimental: Escitalopram
    Escitalopram 20mg tablet by mouth once a day
    Intervention: Drug: escitalopram
  • Placebo Comparator: Placebo
    Placebo 20mg tablet by mouth once a day
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 15, 2011)
74
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2008)
80
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00702780
Other Study ID Numbers  ICMJE SNUDC001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dong Young Lee, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
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
PRS Account Seoul National University Hospital
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP