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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: escitalopram Drug: placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease
Study Start Date : November 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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)


Outcome Measures
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Primary Outcome Measures :
  1. % Change of Hippocampus Volume [ Time Frame: 52 weeks ]
  2. % Change of Whole Brain Volume [ Time Frame: 52 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00702780


Locations
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Korea, Republic of
Kangwon National University Hospital
Chuncheon, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Konkuk University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
H. Lundbeck A/S
Investigators
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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
More Information
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Responsible Party: Dong Young Lee, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00702780    
Other Study ID Numbers: SNUDC001
First Posted: June 20, 2008    Key Record Dates
Results First Posted: June 13, 2014
Last Update Posted: June 13, 2014
Last Verified: May 2014
Keywords provided by Dong Young Lee, Seoul National University Hospital:
Alzheimer's disease
escitalopram
MRI
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Citalopram
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs