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Progression Delaying Effect of Escitalopram in Alzheimer's Disease (ESAD)
This study is currently recruiting participants.
Study NCT00702780   Information provided by Seoul National University Hospital
First Received: June 15, 2008   Last Updated: June 20, 2009   History of Changes

June 15, 2008
June 20, 2009
November 2008
November 2010   (final data collection date for primary outcome measure)
% change of hippocampal and whole brain volume [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00702780 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
 
Progression Delaying Effect of Escitalopram in Alzheimer's Disease
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 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)
 
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Alzheimer's Disease
  • Drug: escitalopram
  • Drug: placebo
  • Experimental: escitalopram 20mg
  • Placebo Comparator: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
80
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 90 Years
No
Contact: Dong Young Lee, MD, PhD 82-2-2072-2205 selfpsy@snu.ac.kr
Contact: IL Han Choo, MD, PhD 82-2-2072-1630 npchoo10@snu.ac.kr
Korea, Republic of
 
NCT00702780
Dong Young Lee / Associate Professor of Neuropsychiatry, Seoul National University Hospital
SNUDC001
Seoul National University Hospital
H. Lundbeck A/S
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
Seoul National University Hospital
June 2009

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